Aflibercept Biosimilar(Zakłady Farmaceutyczne Polpharma SA)

Retinal vein occlusion-related macular edema

European Union
Iceland
Liechtenstein
Norway


ubiquitin associated and SH3 domain containing B


United States
European Union
Switzerland
Iceland
Liechtenstein
Norway


Philadelphia chromosome positive chronic myelogenous leukemia

Acute myeloid leukaemia with 11q23 abnormality

Acute myeloid leukemia with multilineage dysplasia

Adult Acute Monoblastic and Monocytic Leukemia

Adult acute myeloid leukemia with del(5q)

Aggressive-Phase Chronic Myelocytic Leukemia

Anemia, Refractory, With Excess of Blasts

Blast Phase Chronic Granulocytic Leukemia


Adalimumab Biosimilar (Wuhan Institute of Biological Products)

Adalimumab Biosimilar (Wuhan Institute of Biological Products Co., Ltd.)

Recombinant anti-TNFα monoclonal antibody (Wuhan Institute of Biological Products)

Polyarticular Juvenile Idiopathic Arthritis


Philadelphia positive acute lymphocytic leukaemia

Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase with the T315I mutation

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Recurrent Childhood Acute Lymphoblastic Leukemia

Refractory Adult Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia with FLT3/ITD Mutation

BCR-ABL1 positive Acute Lymphoblastic Leukemia

Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia

Philadelphia Chromosome Positive Leukemia

Unresectable Gastrointestinal Stromal Tumor

Philadelphia chromosome positive chronic myelogenous leukemia

United States
China
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


China
Japan
United Kingdom
Australia
Ireland
South Korea
Malta


Chlorpheniramine Maleate/Belladonna Total Alkaloid/Pseudoephedrine Hydrochloride


Advanced Gastroesophageal Junction Adenocarcinoma

Malignant neoplasm of gastro-oesophageal junction

Metastatic Gastroesophageal Junction Adenocarcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

Neuroendocrine neoplasm of gastrointestinal tract

Platinum-Resistant Primary Peritoneal Carcinoma

Recurrent Gastroesophageal Junction Adenocarcinoma

Squamous Cell Carcinoma of Head and Neck


Metastatic castration-resistant prostate cancer

United States
China
Japan
Australia
Austria
Belgium
Cyprus
Czechia
Germany
Estonia
Spain
Finland
France
Greece
Hungary
Ireland
Italy
South Korea
Lithuania
Luxembourg
Latvia
Malta
Netherlands
Poland
Portugal
Romania
Sweden
Slovenia
Slovakia


Recombinant human brain natriuretic peptide (RxD Biopharma)

Nesiritide Recombinant Biosimilar (Suzhou Landing Biopharmaceutical, Inc.)


Microsatellite instability-high Endometrial Carcinoma

Urothelial Carcinoma of the Urinary Bladder

EGFR positive non-small cell lung cancer

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma


Paracetamol, Clemastine Fumarate and Pseudoephedrine Hydrochloride


Chronic lymphocytic leukaemia refractory

Recurrent Anaplastic Large Cell Lymphoma

United States
China
European Union
Japan
Canada
Australia
Switzerland
Iceland
South Korea
Liechtenstein
Norway


Chlorpheniramine Maleate/Scopolamine Hydrobromide Hydrate


Crouzon Syndrome With Acanthosis Nigricans


Malignant neoplasm of gastro-oesophageal junction


United States
China
Canada
Australia
Switzerland
Europe


Obesity due to melanocortin 4 receptor deficiency

United States
European Union
United Kingdom
Canada
Iceland
Liechtenstein
Norway


acetic acid 2-acetoxymethyl-4-(2-amino-purin-9-yl)-butyl ester


Transthyretin-related (ATTR) familial amyloid polyneuropathy

United States
European Union
Japan
United Kingdom
Iceland
Liechtenstein
Norway


Advanced Triple-Negative Breast Carcinoma

Hereditary Leiomyomatosis and Renal Cell Cancer

Metastatic castration-resistant prostate cancer

Metastatic HER2-Negative Breast Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma


Squamous Cell Carcinoma of Head and Neck

Unresectable Lung Non-Small Cell Carcinoma

Urothelial Carcinoma of the Urinary Bladder

United States
China
Canada
Australia
United Arab Emirates
Hong Kong
Israel
Macao
Singapore


Irritable bowel syndrome with constipation

China Japan India Czechia Malaysia Philippines Thailand


Multiple Sclerosis, Secondary Progressive

Spinocerebellar Ataxia, Autosomal Recessive 6

United States
China
European Union
Australia
Iceland
South Korea
Liechtenstein
Norway


Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

United States
China
United Kingdom
Canada
Australia
Austria
Belgium
Czechia
Germany
Denmark
Spain
Finland
France
Ireland
Italy
South Korea
Netherlands
Norway
Poland
Romania
Russia
Sweden
Slovakia


Trifluridine and Tipiracil Hydrochloride

Metastatic Gastroesophageal Junction Adenocarcinoma

HER2 negative Gastroesophageal Junction Adenocarcinoma

Advanced Pancreatic Ductal Adenocarcinoma

Malignant neoplasm of gastro-oesophageal junction

Metastatic Microsatellite Stable Colorectal Carcinoma

Pancreatic neuroendocrine tumour metastatic

United States
China
European Union
Japan
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


重组三价新冠病毒（XBB+BA.5+Delta 变异株）三聚体蛋白疫苗（Sf9细胞）

Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine(Sf9 Cell) (WestVac Biopharma)

Recombinant COVID19 vaccine (Sf9 cells) (trivalent)

Prophylactic vaccine
Multivalent vaccine
Genetically engineered subunit vaccine


Heparin-induced thrombocytopenia and thrombosis

United States
Japan
United Kingdom
Canada
Denmark
Spain
Italy
Norway
Sweden


Pabinafusp Alfa (Genetical Recombination)

Pabinafusp alfa (genetical recombination) (JAN)


Peginterferon alfa-2b/Ribavirin(Merck & Co., Inc.)

Pegylated interferon-alpha-2b + ribavirin


Rituximab biosimilar (Shanghai Institute of Biological Products)

Recombinant chimeric anti-CD20 antibody(Shanghai Institute of Biological Products)

CD20 positive Diffuse Large B-Cell Lymphoma

CD20 Positive B-Cell Non-Hodgkin Lymphoma


COVID-19 Bivalent Vaccine(Original/Omicron BA.1)


Idursulfase (genetical recombination) (JAN)

United States
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Mycobacterium indicus pranii heat-killed

Locally Advanced Head and Neck Squamous Cell Carcinoma


Panitumumab Biosimilar (Qilu Pharmaceutical Co., Ltd.)


Acetaminophen/Chlorpheniramine Maleate/Dextromethorphan Hydrobromide Hydrate/Guaifenesin/Riboflavin


Recombinant polypeptide
Biosimilar
Peptide Hormone


Filgrastim  Biosimilar (Curateq Biologics Pvt Ltd.)


United States
China
Japan
Australia
Austria
Switzerland
Germany
Spain
Finland
Italy
Luxembourg
Norway
Portugal


Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Chronic lymphocytic leukaemia refractory

Recurrent Transformed Chronic Lymphocytic Leukemia

United States
European Union
Canada
Australia
Iceland
Liechtenstein
Norway


Tumor necrosis factor ligand superfamily member 11

European Union
Japan
Iceland
Liechtenstein
Norway


United States
China
Japan
Canada
Australia
Brazil
South Korea
Taiwan Province


Teduglutide Recombinant Biosimilar (Viatris Ltd. (New Zealand))

European Union
Iceland
Liechtenstein
Norway


布洛芬/愈创甘油醚/盐酸伪麻黄碱/氢溴酸右美沙芬水合物/马来酸氯苯那敏/盐酸DL-甲基麻黄碱/盐酸溴己新

Ibuprofen/Guaifenesin/Pseudoephedrine Hydrochloride/Dextromethorphan Hydrobromide Hydrate/Chlorpheniramine Maleate/Methylephedrine Hydrochloride/Bromhexine Hydrochloride


Loteprednol Etabonate Ophthalmic Suspension


T-cell Acute Lymphoblastic Leukemia/Lymphoma

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Refractory T Acute Lymphoblastic Leukemia

CD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma

pediatric lymphoblastic non-Hodgkin's lymphoma

Recurrent Childhood Acute Lymphoblastic Leukemia

T-cell acute lymphoblastic leukemia in relapse

United States
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Complicated lower urinary tract infection


Irritable bowel syndrome with constipation


Hypertrophic Cardiomyopathy without Obstruction

United States
China
European Union
Iceland
Liechtenstein
Norway


European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


Germline BRCA-mutated, HER2-negative metastatic breast cancer

Platinum-sensitive epithelial ovarian cancer

Platinum-Sensitive Fallopian Tube Carcinoma

Platinum-Sensitive Primary Peritoneal Carcinoma

Metastatic castration-resistant prostate cancer

Hormone receptor positive HER2 positive breast cancer

Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma


Hemoglobin glutamer 250 bovine (HbO2 Therapeutics)

Hemoglobin glutamer250 (bovine) HbO2 Therapeutics

Hemoglobin glutamer250 HbO2 Therapeutics

Hemoglobin glutamer250 bovine HbO2 Therapeutics


Pegylated recombinant human granulocyte colony stimulating factor (Jiuyuan Gene)


United States
China
European Union
Japan
Iceland
Liechtenstein
Norway


EGFR ex20ins mutation in non-small cell lung cancer

EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer

EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer

Squamous Cell Carcinoma of Head and Neck


Bevacizumab biosimilar(Samsung Bioepis Co., Ltd.)

EGFR positive Non-squamous non-small cell lung cancer

Platinum-sensitive epithelial ovarian cancer

Platinum-Sensitive Fallopian Tube Carcinoma

Platinum-Sensitive Primary Peritoneal Carcinoma

European Union
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


United States
European Union
Iceland
Liechtenstein
Norway


Natalizumab Biosimilar (Polpharma Biologics)


United States
China
Japan
Taiwan Province


AQP4-IgG positive Neuromyelitis optica spectrum disorder

Chronic lymphocytic leukaemia refractory

Diffuse large B-cell lymphoma refractory


Recombinant human TNK tissue-type plasminogen activator(Recomgen Biotech)

Recombinant Human TNK Tissue-type Plasminogen Activator(rhTNK-tPA)


Sarcoplasmic/endoplasmic reticulum calcium ATPase 1

Sarcoplasmic/endoplasmic reticulum calcium ATPase 2


Hormone receptor positive HER2 negative breast cancer

PIK3CA mutation/HR-positive/HER2-negative Breast Cancer

PIK3CA mutated/HER2 Positive Breast Cancer

Metastatic castration-resistant prostate cancer

Estrogen receptor positive breast cancer

Squamous Cell Carcinoma of Head and Neck

Locally Advanced Malignant Solid Neoplasm

United States
China
European Union
United Kingdom
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Whole-Virion Inactivated SARS-CoV-2 Vaccine

Inactivated vaccine
Prophylactic vaccine


Low-dose topical imiquimod - Moberg Derma


United States
China
United Kingdom
Czechia
Germany
Denmark
Spain
Italy


Bevacizumab Biosimilar (Boan Biological)

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma


FTO alpha-ketoglutarate dependent dioxygenase


Recombinant humanized anti-PD-1 monoclonal antibody(Taizhou Hanzhong Biomedical Co., Ltd.)

Microsatellite Instability-high Solid Tumors

Microsatellite instability-high colorectal cancer

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Locally Advanced Head and Neck Squamous Cell Carcinoma

Metastatic Triple-Negative Breast Carcinoma


Liraglutide Biosimilar (Tonghua Dongbao)


Recombinant vector vaccine
Prophylactic vaccine


アパダムターゼ アルファ（遺伝子組換え）/シナキサダムターゼ アルファ（遺伝子組換え）（JAN）

ADAM metallopeptidase with thrombospondin type 1 motif 13

Congenital Thrombotic Thrombocytopenic Purpura

Thrombotic Thrombocytopenic Purpura, Acquired

United States
European Union
Japan
United Kingdom
Australia
Iceland
Liechtenstein
Norway


Pyridoxamine 5-Prime-Phosphate Oxidase Deficiency


Transforming growth factor-beta-1 gene therapy


Denosumab Biosimilar (Qilu Pharmaceutical Co., Ltd.)

Recombinant human anti-RANKL momoclonal antibody(Qilu Pharmaceutical Co., Ltd.)

地舒单抗生物类似药（Qilu Pharmaceutical Co., Ltd.）

Tumor necrosis factor ligand superfamily member 11


Polyarticular Juvenile Idiopathic Arthritis


Liraglutide biosimilar(Zhuhai United Laboratories)

Liraglutide Biosimilar (Zhuhai United Pharmaceutical Co.,Ltd.)


Hormone receptor positive HER2 negative breast cancer

Metastatic Microsatellite Stable Colorectal Carcinoma

PD-L1 positive Non-Small Cell Lung Cancer

Metastatic Triple-Negative Breast Carcinoma

HR Positive/HER2 Negative/Node positive breast cancer

Advanced Esophageal Squamous Cell Carcinoma

Diffuse large B-cell lymphoma refractory

Epstein-Barr virus associated Solid Tumors

Metastatic Carcinoma to the Uterine Cervix

Metastatic human epidermal growth factor 2 positive carcinoma of breast


Recombinant Human Hyaluronidase (BaoPharma)

Recombinant human hyaluronidase(Kangju Biotechnology)


Progesterone Sustained-release vaginal gel

Thyroid Hormone Plasma Membrane Transport Defect

United States
China
Japan
Canada
South Korea


Bevacizumab biosimilar(Qilu Pharmaceutical Co., Ltd.)

Recombinant Anti-VEGF Humanized Monoclonal Antibody

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma


Ocriplasmin (genetical recombination) (JAN)


Isocitrate dehydrogenase [NADP] cytoplasmic

Isocitrate dehydrogenase [NADP], mitochondrial

United States
European Union
Japan
United Kingdom
Canada
Australia
India
Iceland
South Korea
Liechtenstein
Norway


Emtricitabine and tenofovir disoproxil fumarate

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


对乙酰氨基酚/愈创甘油醚/DL-甲基麻黄碱盐酸盐/氢溴酸右美沙芬水合物/马来酸氯苯那敏

Acetaminophen/Guaifenesin/DL-Methylephedrine Hydrochloride/Dextromethorphan Hydrobromide Hydrate/Chlorpheniramine Maleate


CD19-positive B-cell acute lymphoblastic leukemia

Refractory Adult Acute Lymphoblastic Leukemia

Recurrent Childhood Acute Lymphoblastic Leukemia


Human Prothrombin Complex (Weiguang Biological Products)


Human coagulation factor VIII (Nanyue Bio)


B-VEC formulated as an eyedrop(Krystal Biotech)

Epidermolysis Bullosa Dystrophica, Pasini Type

United States
European Union
Japan
Iceland
Liechtenstein
Norway


United States
China
Japan
Canada
Australia
Switzerland


Recombinant coronavirus (SARSCoV-2) spike protein antigen(Shionogi)

Prophylactic vaccine
Genetically engineered subunit vaccine


European Union
United Kingdom
Iceland
Liechtenstein
Norway


Proto-oncogene tyrosine-protein kinase ROS


Glioblastoma Harboring BRAF V600 Mutation

BRAF V600E mutant Non-small Cell Lung Cancer

United States
China
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Skin structures and soft tissue infections

Non-complicated skin and skin structure infection

United States
China
Japan
Australia
South Korea


Metastatic Microsatellite Stable Colorectal Carcinoma

Cutaneous Squamous Cell Carcinoma of the Head and Neck

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

United States
European Union
United Kingdom
Canada
Australia
Iceland
Liechtenstein
Norway


EGFR mutation MET positive Non-small Cell Lung Cancer

MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer

MET gene amplification Non-small Cell Lung Cancer

Locally Advanced Lung Non-Small Cell Carcinoma

c-Met positive non-small cell lung cancer

EGFR positive non-small cell lung cancer

Locally Advanced Malignant Solid Neoplasm


Congenital Bilateral Aplasia of Vas Deferens

Metabolic Dysfunction Associated Steatohepatitis


对乙酰氨基酚/愈创甘油醚/氢溴酸右美沙芬水合物/盐酸DL-甲基麻黄碱/盐酸溴己新

Acetaminophen/Guaifenesin/Dextromethorphan Hydrobromide Hydrate/DL-Methylephedrine Hydrochloride/Bromhexine Hydrochloride


Levocarnitine propionate hydrochloride (USAN)


c-Met positive non-squamous non-small cell lung cancer

Metastatic Clear Cell Renal Cell Carcinoma


Non-erosive gastro-esophageal reflux disease

United States
China
Japan
Australia
Taiwan Province


Anthrax Vaccine Adsorbed, Adjuvanted (Emergent BioSolutions)


Sleep Initiation and Maintenance Disorders


BRCA Mutation Castration-Resistant Prostate Cancer

HRR Gene-mutated Castration-Resistant Prostate Cancer

Metastatic Castration-Sensitive Prostate Carcinoma

Metastatic castration-resistant prostate cancer

United States
China
European Union
Canada
Iceland
South Korea
Liechtenstein
Norway


Recurrent Squamous Cell Carcinoma of the Head and Neck

Refractory B Acute Lymphoblastic Leukemia

CD20 positive Diffuse Large B-Cell Lymphoma

Refractory Central Nervous System Lymphoma

Recurrent Central Nervous System Lymphoma

Secondary Central Nervous System Lymphoma

Advanced Pancreatic Neuroendocrine Tumor

Anemia, Refractory, With Excess of Blasts

Chronic lymphocytic leukaemia refractory

Diffuse large B-cell lymphoma refractory

EGFR C797S Mutation Non-small Cell Lung Cancer

Monoclonal Gammopathy of Undetermined Significance

Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia

Philadelphia chromosome positive chronic myelogenous leukemia

Philadelphia positive acute lymphocytic leukaemia

Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type

Refractory Mature B-Cell Non-Hodgkin Lymphoma

Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma

Steroid Refractory Graft Versus Host Disease

United States
China
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Mexico
Norway


United States
European Union
United Kingdom
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Female infertility associated with anovulation


United States
European Union
Iceland
Liechtenstein
Norway


Insulin glargine biosimilar(Tonghua Dongbao Pharmaceutical Co., Ltd.)

Insulin glargine  Biosimilar (Tonghua Dongbao Pharmaceutical Co., Ltd.)


Elotuzumab (genetical recombination) (JAN)

Immunoglobulin G1, anti-(human protein CS1) (human-mouse HuLuc63 heavy chain), disulfide with human-mouse HuLuc63 kappa-chain, dimer

United States
European Union
Japan
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


United States
European Union
Japan
Iceland
South Korea
Liechtenstein
Norway


United States
China
Japan
Canada
Australia
South Korea


IL-15N72D:IL-15RαSu/Fc fusion protein complex

Non-Muscle Invasive Bladder Urothelial Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

Squamous Cell Carcinoma of Head and Neck

Urothelial Carcinoma of the Urinary Bladder

Advanced Triple-Negative Breast Carcinoma

Anemia, Refractory, With Excess of Blasts

Core binding factor acute myeloid leukemia

Refractory Indolent Non-Hodgkin Lymphoma

United States
European Union
United Kingdom
Iceland
Liechtenstein
Macao
Norway
Saudi Arabia


glomerulonephritis chronic complement component 3 glomerulopathy

United States
European Union
Japan
United Kingdom
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Disruptive, Impulse Control, and Conduct Disorders

Sleep Initiation and Maintenance Disorders


BCMAxCD3 bispecific antibody(Regeneron Pharmaceuticals, Inc.)

Monoclonal Gammopathy of Undetermined Significance


Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis


Dementia due to Alzheimer's disease (disorder)


Non-degrading molecular glue
Synthetic peptide
Cyclic Peptide


Recombinant COVID-19 Vaccine ( CanSino Biotech)

Adenovirus type5 vectored COVID19 vaccine

Recombinant SARS-CoV-2 Ad5 vectored vaccine

China
Chile
Hong Kong
Hungary
Indonesia
Morocco
Mexico
Malaysia
Pakistan


Recombinant human interferon alpha-1b(Beijing Tri-Prime Gene Pharmaceutical Co Ltd)

Interferon-alpha/beta receptor alpha chain

Pneumonia due to respiratory syncytial virus


Diphtheria toxin-il-3 fusion protein targeting IL-3 receptor

Blastic Plasmacytoid Dendritic Cell Neoplasm

Recurrent B Acute Lymphoblastic Leukemia

Refractory B Acute Lymphoblastic Leukemia

Refractory T Acute Lymphoblastic Leukemia

Treatment related acute myeloid leukaemia

United States
European Union
Japan
Iceland
Liechtenstein
Norway


Renal Tubular Acidosis, Proximal, With Ocular Abnormalities and Mental Retardation

United States
China
Japan
United Kingdom


Sleep Initiation and Maintenance Disorders

United States
European Union
Japan
United Kingdom
Canada
Iceland
Liechtenstein
Norway


Polyarticular Juvenile Idiopathic Arthritis

European Union
Japan
United Kingdom
Iceland
Liechtenstein
Norway


B-cell antigen receptor complex-associated protein beta chain

Diffuse large B-cell lymphoma refractory

Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type

T-cell/histiocyte rich large B-cell lymphoma

CD20 positive Diffuse Large B-Cell Lymphoma

High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements

Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Refractory Aggressive Non-Hodgkin Lymphoma

Epstein-Barr virus associated Diffuse Large B-Cell Lymphoma

Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

United States
China
European Union
Japan
United Kingdom
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway
Taiwan Province


United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Difenidol Hydrochloride/Scopolamine Hydrobromide Hydrate/Riboflavin

Calcium release-activated calcium channel protein 1


Sarcoplasmic/endoplasmic reticulum calcium ATPase 1

Sarcoplasmic/endoplasmic reticulum calcium ATPase 2

Metabolic Dysfunction Associated Steatohepatitis

United States
China
European Union
United Kingdom
Canada
Iceland
Liechtenstein
Norway


Nemolizumab (genetical recombination) (JAN)

United States
European Union
Japan
United Kingdom
Canada
Australia
Switzerland
Iceland
South Korea
Liechtenstein
Norway


Vascular endothelial growth factor receptor

EGFR positive non-small cell lung cancer


United States
China
European Union
Canada
Iceland
South Korea
Liechtenstein
Norway


MRSA - Methicillin resistant Staphylococcus aureus infection

Complicated skin and soft tissue infection

Complicated skin and skin structure infection


Denosumab Biosimilar (Zydus Lifesciences Ltd.)

Tumor necrosis factor ligand superfamily member 11


COVID-19 messenger ribonucleic acid(mRNA) vaccine from Stemirna Therapeutics

SARS-Cov-2 mRNA vaccine immunization(Stemirna Therapeutics)


Progressive fibrotic interstitial lung disease


KRAS G12C mutant Non-small Cell Lung Cancer

KRAS G12C mutant non-squamous non-small cell lung cancer

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

KEAP1 Mutation Non-Small Cell Lung Cancer

United States
European Union
United Kingdom
Iceland
Liechtenstein
Norway


Acetaminophen/Pseudoephedrine Hydrochloride/Chlorpheniramine Maleate/Methylephedrine Hydrochloride


United States
European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


Cystic fibrosis transmembrane conductance regulator

United States
Brazil
Botswana
Ecuador
Zimbabwe


Denosumab Biosimilar (Teva Pharmaceutical Industries Ltd.)

地舒单抗生物类似药（Teva Pharmaceutical Industries Ltd.）

United States
European Union
Iceland
Liechtenstein
Norway


Golimumab Biosimilar (JAMP Pharma Corp.)


United States
China
European Union
Japan
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Multiple Sclerosis, Secondary Progressive

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

United States
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Budesonide/Glycopyrronium Bromide/Formoterol Fumarate Hydrate

Moderate chronic obstructive pulmonary disease

Severe chronic obstructive pulmonary disease

United States
China
European Union
Japan
United Kingdom
Canada
Iceland
Liechtenstein
Norway


United States
European Union
Canada
Australia
Iceland
Liechtenstein
Norway


Hormone receptor positive HER2 negative breast cancer

Locally Advanced Lung Non-Small Cell Carcinoma

Metastatic human epidermal growth factor 2 positive carcinoma of breast


Recombinant Human TNF Receptor-IgG Fusion Protein (Celgen Bio)


Aflibercept (genetical recombination) (JAN)

Retinal vein occlusion-related macular edema

Metastatic castration-resistant prostate cancer

Proliferative retinopathy with diabetes mellitus

United States
China
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Anemia, Refractory, With Excess of Blasts

Chronic lymphocytic leukaemia refractory

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

United States
European Union
United Kingdom
Canada
Australia
Belarus
Germany
Denmark
Ireland
Iceland
Liechtenstein
Netherlands
Norway
Russia
Ukraine


United States
China
European Union
Iceland
South Korea
Liechtenstein
Norway


Insulin aspart Biosimilar (Guangdong HEC Technology Holding Co., Ltd.)


Nuclear factor erythroid 2-related factor 2


Interleukin-1 receptor-associated kinase 1

Aggressive-Phase Chronic Myelocytic Leukemia

BCR-ABL Negative Atypical Chronic Myeloid Leukemia

Blast Phase Chronic Granulocytic Leukemia

Treatment related acute myeloid leukaemia


COVID-19 Vaccine (ChAdOx1-S [recombinant])(AstraZeneca Plc)

コロナウイルス（SARS-CoV-2）ワクチン（遺伝子組換えサルアデノウイルスベクター）(AstraZeneca Plc)

Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19


Estrogen receptor positive breast cancer

Locally Advanced Malignant Solid Neoplasm

Unresectable Pleural Malignant Mesothelioma

United States
China
European Union
Japan
Australia
Brazil
Iceland
Liechtenstein
Norway


重组新型冠状病毒疫苗（CHO细胞）(Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.)

Recombinant SARS-CoV-2 vaccine (CHO Cell)(Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.)

Recombinant new coronavirus vaccine (CHO cell)Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.)


United States
Japan
United Kingdom
Australia


Proto-oncogene tyrosine-protein kinase ROS

c-Met positive non-small cell lung cancer


Sirolimus AngioInfusion Balloon-Virtue SAB(Terumo/Orchestra)

Angiofibroma associated with tuberous sclerosis

Chronic thromboembolic pulmonary hypertension

Central Nervous System Cavernous Hemangioma

Philadelphia positive acute lymphocytic leukaemia

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Recurrent Adult Acute Lymphoblastic Leukemia

Acute myeloid leukaemia with 11q23 abnormality

Adult Acute Monoblastic and Monocytic Leukemia

Aggressive-Phase Chronic Myelocytic Leukemia

BCR-ABL Negative Atypical Chronic Myeloid Leukemia

Blast Phase Chronic Granulocytic Leukemia

Blastic Plasmacytoid Dendritic Cell Neoplasm

Chronic lymphocytic leukaemia refractory

Locally Advanced Malignant Solid Neoplasm

Metastatic castration-resistant prostate cancer

pediatric lymphoblastic non-Hodgkin's lymphoma

Philadelphia chromosome positive chronic myelogenous leukemia

Primary Cutaneous Anaplastic Large Cell Lymphoma

Recurrent Anaplastic Large Cell Lymphoma

Recurrent Childhood Acute Lymphoblastic Leukemia

Resectable Lung Non-Small Cell Carcinoma

Stage II Non-Contiguous Adult Diffuse Small Cleaved Cell Lymphoma

untreated pediatric acute nonlymphocytic leukemia

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Platelet-derived growth factor receptor alpha

Platelet-derived growth factor receptor beta

Vascular endothelial growth factor receptor 1

Vascular endothelial growth factor receptor 2

Vascular endothelial growth factor receptor 3

Malignant Gastric Gastrointestinal Stromal Tumor

Pancreatic neuroendocrine tumour metastatic

Well Differentiated Pancreatic Endocrine Tumor

Advanced Pancreatic Neuroendocrine Tumor

Advanced Triple-Negative Breast Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Malignant neoplasm of gastro-oesophageal junction

Metastatic castration-resistant prostate cancer

Metastatic Clear Cell Renal Cell Carcinoma

Non-Muscle Invasive Bladder Urothelial Carcinoma

Recurrent Gastroesophageal Junction Adenocarcinoma

Unresectable Gastrointestinal Stromal Tumor

Unresectable Lung Non-Small Cell Carcinoma

Urothelial Carcinoma of the Urinary Bladder


[Lu-177]-DOTATATE(Advanced Accelerator Applications SA)

Somatostatin Receptor-Positive Neuroendocrine Tumor

SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor

Peptide Conjugate Radionuclide
Cyclic Peptide
Therapeutic radiopharmaceuticals

United States
European Union
Japan
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Mycobacterium tuberculosis derived antigens(Vakzine)

European Union
United Kingdom
India
Iceland
Liechtenstein
Norway


European Union
Iceland
Liechtenstein
Norway


Transthyretin-related (ATTR) familial amyloid polyneuropathy

United States
European Union
Japan
United Kingdom
Canada
Australia
Brazil
Iceland
South Korea
Liechtenstein
Norway


Anemia, Refractory, With Excess of Blasts


EGFR positive non-small cell lung cancer


Insulin aspart biosimilar(Geropharm LLC)

Insulin aspart Biosimilar (Geropharm LLC)


Human immunodeficiency virus type 1 Pol protein


Locally Advanced Lung Non-Small Cell Carcinoma

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

Squamous Cell Carcinoma of Head and Neck

Breast Carcinoma Metastatic in the Brain

Metastatic HER2-Negative Breast Carcinoma

Platinum-Resistant Epithelial Ovarian Carcinoma

Platinum-Resistant Fallopian Tube Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma


Metformin Hydrochloride/Lobeglitazone Sulfate/Empagliflozin L-ProlineEmpagliflozin L-Proline

Peroxisome proliferator-activated receptor γ

Protein kinase AMP-activated non-catalytic subunit beta 1


Sodium chondroitin sulfate/Hypromellose/Sodium chloride/Potassium chloride

Sodium Chondroitin Sulfate/Hypromellose 2910/Sodium Chloride/Potassium Chloride


Henagliflozein Proline/Retagliptin Phosphate/Metformin Hydrochloride


Ustekinumab Biosimilar (Samsung Bioepis Co., Ltd.)


Metastatic Pancreatic Ductal Adenocarcinoma

Locally Advanced Pancreatic Adenocarcinoma

Metastatic Triple-Negative Breast Carcinoma


glomerulonephritis chronic complement component 3 glomerulopathy

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Early onset of age-related macular degeneration

Infantile multisystem neurologic-endocrine-pancreatic disease


Emtricitabine/Rilpivirine Hydrochloride/Tenofovir Disoproxil Fumarate

Emtricitabine Rilpivirine and Tenofovir Disoproxil Fumarate

Emtricitabine/tenofovir disoproxil fumarate/TMC 278


Human prothrombin complex(Hualan Genetic Engineering Co Ltd)


China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Platelet-derived growth factor receptor alpha

Platelet-derived growth factor receptor beta

Vascular endothelial growth factor receptor 1

Vascular endothelial growth factor receptor 2

Vascular endothelial growth factor receptor 3

Locally Advanced Unresectable Gastric Adenocarcinoma

Locally Advanced Malignant Solid Neoplasm

Metastatic Gastroesophageal Junction Adenocarcinoma

Microsatellite instability-high colorectal cancer

Squamous Cell Carcinoma of Head and Neck

Unresectable Gastrointestinal Stromal Tumor

Urothelial Carcinoma of the Urinary Bladder


Isocitrate dehydrogenase [NADP] cytoplasmic

CCUS Clonal Cytopenia of Undetermined Significance

Acute myeloid leukaemia with 11q23 abnormality


Protein kinase AMP-activated non-catalytic subunit beta 1


Recombinant human serum albumin-human granulocyte colony stimulating factor fusion protein(Mabwell)

重组 (酵母分泌型)人血清白蛋白-人粒细胞集落刺激因子(I)融合蛋白 (上海迈威生物)


Acute myeloid leukemia with mutated NPM1

Malignant Gastric Gastrointestinal Stromal Tumor


(5-benzoyl-1H-benzimidazol-2-yl)-carbamic acid methyl ester

TRAF2 and NCK-interacting protein kinase


Denosumab biosimilar (Alkem Laboratories)

Denosumab Biosimilar (Alkem Laboratories Ltd.)

Tumor necrosis factor ligand superfamily member 11


Type 2 diabetes mellitus with established diabetic nephropathy

United States
China
Japan
United Kingdom
Germany


COVID 19 vaccine( Gamaleya National Research Center of Epidemiology and Microbiology)

COVID-2019 vaccine (Gamaleya National Research Center of Epidemiology and Microbiology


United States
China
European Union
Iceland
Liechtenstein
Norway


Insulin Lispro (Genetical Recombination)

Mixed Protamine Zinc Recombinant Human Insulin Lispro

Hyperinsulinemic Hypoglycemia, Familial, 7

United States
China
European Union
Japan
Canada
Iceland
Liechtenstein
Norway


Porcine vasoactive intestinal octacosapeptide

Vasoactive intestinal octacosapeptide (pig)

Vasoactive intestinal octacosapeptide (swine)

Vasoactive intestinal polypeptide receptor 1

Vasoactive intestinal polypeptide receptor 2


Hyaluronidase (glycoprotein, sheep testis isoenzyme)


Metabolic dysfunction-associated steatotic liver disease

Metabolic Dysfunction Associated Steatohepatitis

Heart failure with mid range ejection fraction

Heart failure with normal ejection fraction

Heart failure with reduced ejection fraction


Alkaline phosphatase, tissue-nonspecific isozyme

Locally Advanced Head and Neck Squamous Cell Carcinoma

Squamous Cell Carcinoma of Head and Neck

Squamous cell carcinoma of the hypopharynx

Unresectable Lung Non-Small Cell Carcinoma


Refractory T Acute Lymphoblastic Leukemia

T-cell acute lymphoblastic leukemia in relapse

Treatment related acute myeloid leukaemia

Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia


Sleep Initiation and Maintenance Disorders


Bimekizumab (genetical recombination) (JAN)

United States
China
European Union
Japan
United Kingdom
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Teriparatide biosimilar(Accord Healthcare S.L.U.)

teriparatide biosimilar(Accord Healthcare S.L.U.)

European Union
Australia
Iceland
Liechtenstein
Norway


KRAS G12C mutant Non-small Cell Lung Cancer

KRAS G12C mutant non-squamous non-small cell lung cancer


Attention Deficit Disorder With Hyperactivity

Postural Orthostatic Tachycardia Syndrome


Proto-oncogene tyrosine-protein kinase ROS

Neurotrophic tyrosine kinase receptor type 2

Neurotrophic tyrosine kinase receptor type 3

Reactive oxygen species 1 positive non-small cell lung cancer

NTRK fusion-positive Non-small Cell Lung Cancer

Locally Advanced Malignant Solid Neoplasm

Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma

HR Positive/HER2 Negative Lobular Carcinoma

United States
China
European Union
Japan
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway
Taiwan Province


Adult Acute Monoblastic and Monocytic Leukemia

Adult acute myeloid leukemia with del(5q)

Anemia, Refractory, With Excess of Blasts

Chronic idiopathic thrombocytopenic purpura

Metabolic Dysfunction Associated Steatohepatitis

United States
China
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Recombinant Botulinum Toxin Type A (Claruvis)

Recombinant Botulinum Toxin Type A(Chongqing Yuyan Pharmaceutical)

Recombinant botulinum toxin type A (MingMed Bio)


Metastatic castration-resistant prostate cancer

United States
European Union
Japan
United Kingdom
Canada
Iceland
Liechtenstein
Norway


Irinotecan Hydrochloride Lioposome (Heng Rui)

Advanced Esophageal Squamous Cell Carcinoma


Hypoxia-inducible factor prolyl hydroxylase

United States
European Union
Japan
United Kingdom
Australia
Switzerland
Iceland
South Korea
Liechtenstein
Norway


Pioglitazone Hydrochloride Orally Disintegrating

Peroxisome proliferator-activated receptor γ

Metabolic dysfunction-associated steatotic liver disease

United States
China
European Union
Japan
Australia
Brazil
Iceland
South Korea
Liechtenstein
Norway


Respiratory Syncytial Virus Vaccine(Moderna)

Respiratory Syncytial Virus (RSV) pre-fusion F protein (Moderna)

Respiratory syncytial virus (RSV) vaccine (Moderna)

Pneumonia due to respiratory syncytial virus

United States
European Union
United Kingdom
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Porcine Fibrin sealant (Shanghai Likangrui )


Skin structures and soft tissue infections


Chronic Kidney Disease-Mineral and Bone Disorder

United States
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Vascular endothelial growth factor receptor 3

Vascular endothelial growth factor receptor 1

Vascular endothelial growth factor receptor 2

Locally Advanced Lung Non-Small Cell Carcinoma

Advanced Lung Non-Small Cell Squamous Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

Progressive fibrotic interstitial lung disease

Locally Advanced Esophageal Squamous Cell Carcinoma

Resectable Lung Non-Small Cell Carcinoma

Metastatic Carcinoma to the Uterine Cervix

Hormone receptor positive HER2 negative breast cancer

Platinum-Resistant Epithelial Ovarian Carcinoma

EGFR positive non-small cell lung cancer

Unresectable Esophageal Squamous Cell Carcinoma

KRAS G12C mutant Non-small Cell Lung Cancer

Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma

PD-L1 positive Non-Small Cell Lung Cancer

Unresectable Lung Non-Small Cell Carcinoma

Advanced Thyroid Gland Medullary Carcinoma

Advanced Triple-Negative Breast Carcinoma

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

Metastatic Esophageal Squamous Cell Carcinoma

Metastatic Gastroesophageal Junction Adenocarcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Microsatellite Instability-high Solid Tumors

Platinum-Resistant Primary Peritoneal Carcinoma

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

Recurrent Triple-Negative Breast Carcinoma

Squamous Cell Carcinoma of Head and Neck


United States
Australia
Spain
Netherlands
Portugal


Adalimumab biosimilar(Biocad Medical, Inc.)


Idiopathic pulmonary arterial hypertension


Tumor necrosis factor ligand superfamily member 11


HPV positive oropharyngeal squamous cell carcinoma

Human Papillomavirus-Related Anal Squamous Cell Carcinoma

Human Papillomavirus-Related Cervical Carcinoma

Human Papillomavirus-Related Squamous Cell Carcinoma of the Penis

Human Papillomavirus-Related Vulvar Squamous Cell Carcinoma

Secondary malignant neoplasm of peritoneum

Recurrent Platinum-Resistant Fallopian Tube Carcinoma

Acute myeloid leukemia with multilineage dysplasia

Adult Acute Monoblastic and Monocytic Leukemia

Adult acute myeloid leukemia with del(5q)

Aggressive-Phase Chronic Myelocytic Leukemia

Anemia, Refractory, With Excess of Blasts

Blast Phase Chronic Granulocytic Leukemia

Childhood Acute Monoblastic Leukemia and Acute Monocytic Leukemia

Chronic lymphocytic leukaemia refractory

Estrogen receptor positive breast cancer

Estrogen receptor-negative breast cancer

MAGE-A3 Positive Muscle Invasive Bladder Carcinoma

Metastatic Clear Cell Renal Cell Carcinoma

Philadelphia chromosome positive chronic myelogenous leukemia

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

progesterone receptor-negative breast cancer

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Childhood Acute Lymphoblastic Leukemia

Refractory cytopenia with multilineage dysplasia and ringed sideroblasts

Stage II Non-Contiguous Adult Diffuse Small Cleaved Cell Lymphoma

Steroid Refractory Graft Versus Host Disease

Treatment related acute myeloid leukaemia

untreated pediatric acute nonlymphocytic leukemia


Factor VIII(China Resources Boya Bio-Pharmaceutical Group)


United States
China
Australia
Switzerland
South Korea


Metastatic castration-resistant prostate cancer

CD-30 positive Peripheral T-Cell Lymphoma

Estrogen receptor positive breast cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Perennial allergic rhinitis with seasonal variation

Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia

Philadelphia positive acute lymphocytic leukaemia


Transient receptor potential cation channel subfamily M member 8


Peroxisome proliferator-activated receptor α

Metabolic Dysfunction Associated Steatohepatitis


Bevacizumab biosimilar (Nichi-Iko Pharmaceutical)


United States
China
European Union
Japan
Canada
Australia
Switzerland
Iceland
Liechtenstein
Norway


Insulin lispro biosimilar(Geropharm LLC)

Insulin lispro Biosimilar (Geropharm LLC)


Transient receptor potential cation channel subfamily V member 1


KRAS-mutated low-grade serous ovarian cancer

thyroid gland poorly differentiated carcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

KRAS G12C mutant Non-small Cell Lung Cancer

BRAF Mutation Non-small Cell Lung Cancer


Self-Amplifying mRNA Ancestral-strain Monovalent Vaccine(Arcturus Therapeutics)

European Union
Japan
United Kingdom
Iceland
Liechtenstein
Norway


Recombinant Human Coagulation Factor VIII (Takeda)

Rurioctocog Alfa (Genetical Recombination)


Vascular endothelial growth factor receptor 1

Vascular endothelial growth factor receptor 2

Vascular endothelial growth factor receptor 3

Advanced Gastroesophageal Junction Adenocarcinoma

Metastatic Microsatellite Stable Colorectal Carcinoma

Advanced Lung Non-Small Cell Squamous Carcinoma

Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Hormone Receptor Positive Breast Adenocarcinoma

Locally Advanced Malignant Solid Neoplasm

Metastatic Triple-Negative Breast Carcinoma

United States
China
European Union
Japan
United Kingdom
Canada
Australia
Hong Kong
Iceland
South Korea
Liechtenstein
Macao
Norway


RANIBIZUMABU BS INTRAVITREAL INJECTION KIT 10mg/mL(SENJU)

RANIBIZUMABU BS INTRAVITREAL INJECTION KIT 10mg/mL「SENJU」

Ranibizumab  Biosimilar (Senju Pharmaceutical Co., Ltd.)

雷珠单抗生物类似药（Senju Pharmaceutical Co., Ltd.）

Retinal vein occlusion-related macular edema


Hyperinsulinemic Hypoglycemia, Familial, 7

United States
European Union
Iceland
Liechtenstein
Norway


Arthropathy, Progressive Pseudorheumatoid, of Childhood

Epilepsy, Female-Restricted, With Mental Retardation

United States
China
European Union
United Kingdom
Iceland
Kuwait
Liechtenstein
Norway


Heart failure with normal ejection fraction

Idiopathic pulmonary arterial hypertension

Brazil
South Korea
Malaysia
Philippines
Russia


Dual specificity mitogen-activated protein kinase kinase 1

Dual specificity mitogen-activated protein kinase kinase 2

BRAF V600E mutant Non-small Cell Lung Cancer

BRAF Mutation Non-small Cell Lung Cancer

Advanced Lung Non-Small Cell Squamous Carcinoma

Advanced Triple-Negative Breast Carcinoma

Glioblastoma Harboring BRAF V600 Mutation

KRAS-mutated low-grade serous ovarian cancer

Metastatic Microsatellite Stable Colorectal Carcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

Philadelphia positive acute lymphocytic leukaemia

Platinum-Resistant Primary Peritoneal Carcinoma

Recurrent Primary Peritoneal Low Grade Serous Adenocarcinoma


Tumor necrosis factor ligand superfamily member 11

United States
European Union
United Kingdom
Canada
Iceland
Liechtenstein
Norway


European Union
Japan
Iceland
Liechtenstein
Norway


Candesartan cilexetil/amlodipine - HanAll BioPharma


Ezetimibe/Fimasartan Potassium Trihydrate/Atorvastatin Calcium


Cobicistat /Darunavir/Emtricitabine/Tenofovir Alafenamide Fumarate

ダルナビル エタノール付加物/コビシスタット/エムトリシタビン/テノホビル アラフェナミドフマル酸塩

Darunavir / Cobicistat / Emtricitabine / Tenofovir Alafenamide

Darunavir Ethanolate/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fumarate

Human immunodeficiency virus type 1 Pol protein

United States
European Union
Japan
Canada
Iceland
Liechtenstein
Norway


United States
European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


United States
China
European Union
Japan
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Ustekinumab Biosimilar (Qyuns Therapeutics)

Ustekinumab Biosimilar (Qyuns Therapeutics Co., Ltd.)


Molybdenum Cofactor Deficiency, Complementation Group A

United States
European Union
United Kingdom
Israel
Iceland
Liechtenstein
Norway


阿达木单抗生物类似药(Mochida Pharmaceutical Co., Ltd.)

Adalimumab biosimilar(Mochida Pharmaceutical Co., Ltd.)

Adalimumab Biosimilar (Mochida Pharmaceutical Co., Ltd.)

阿达木单抗生物类似药（Mochida Pharmaceutical Co., Ltd.）

Polyarticular Juvenile Idiopathic Arthritis


Denosumab Biosimilar (Novartis Pharma AG)

Tumor necrosis factor ligand superfamily member 11

United States
European Union
Australia
Iceland
Liechtenstein
Norway


Pegfilgrastim biosimilar(Adello Biologics LLC)

Pegfilgrastim biosimilar(KASHIV BIOSCIENCES LLC)


Berberine Tannate/Scopolia Extract Powder 33.3%/Ursodeoxycholic Acid/Bismuth Subnitrate


Human Fibrinogen(Shandong Taibang Biological Products)


Nartograstim (genetical recombination) (JP17)


Liraglutide Biosimilar (Cipla Australia Pty Ltd.)


United States
China
Canada
Australia
Mexico


ATP binding cassette subfamily B member 11

potassium inwardly rectifying channel subfamily J member 11

6q24-Related Transient Neonatal Diabetes Mellitus

United States
China
European Union
Japan
United Kingdom
Iceland
Liechtenstein
Norway


Semaglutide (genetical recombination) (JAN)

Metabolic Dysfunction Associated Steatohepatitis

Dementia due to Alzheimer's disease (disorder)

Metabolic dysfunction-associated steatotic liver disease

Heart failure with normal ejection fraction

United States
China
European Union
Japan
United Kingdom
Canada
Australia
India
Iceland
South Korea
Liechtenstein
Norway
South Africa


Immunoglobulin g1, bispecific, anti-(human epidermal growth factor receptors, her2 and her3) (humanized clone mcla-128 .gamma.1-chain), disulfide with humanized clone mcla-128 light chain, dimer

Mcla-128 (igg1 bispecific antibody with enhanced antibody-dependent cell-mediated cytotoxicity (adcc) activity targeting her2 and her3 receptors.)

Adenocarcinoma of pancreas with NRG1 fusion

NRG1 Fusion Positive non-small cell lung cancer

Metastatic castration-resistant prostate cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast


Belladonna Total Alkaloid/Chlorpheniramine Maleate/DL-Methylephedrine Hydrochloride


Metastatic HER2 positive gastroesophageal junction cancer

HER2 positive Gastrooesophageal junction cancer


Adjusted fibrinogen replacement strategy


Tumor necrosis factor ligand superfamily member 13

B-cell-activating factor/B lymphocyte stimulator

Interstitial lung disease due to connective tissue disease

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis


Epstein-Barr virus specific cytotoxic T-lymphocytes

EBV-Related Post-Transplant Lymphoproliferative Disorder

Epstein-Barr virus associated lymphoproliferative disorder

Epstein-Barr virus associated Nasopharyngeal Carcinoma

European Union
Iceland
Liechtenstein
Norway


Flumatinib mesylate - Jiangsu Hansoh Pharmaceutical

Aggressive-Phase Chronic Myelocytic Leukemia

Blast Phase Chronic Granulocytic Leukemia

Philadelphia chromosome positive chronic myelogenous leukemia

Philadelphia chromosome-positive chronic myeloid  leukemia in chronic phase


Squamous cell carcinoma of the oral cavity

Metastatic Cervical Squamous Cell Carcinoma

Locally Advanced Esophageal Squamous Cell Carcinoma

Locally Advanced Gastroesophageal Junction Adenocarcinoma

PD-L1-positive head and neck squamous cell carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Germline BRCA-mutated, HER2-negative metastatic breast cancer

Recurrent Squamous Cell Carcinoma of the Head and Neck

Resectable Lung Non-Small Cell Carcinoma

Metastatic Carcinoma to the Uterine Cervix

Urothelial Carcinoma of the Urinary Bladder

Advanced Head and Neck Squamous Cell Carcinoma

Advanced Triple-Negative Breast Carcinoma

Malignant neoplasm of gastro-oesophageal junction

Metastatic Triple-Negative Breast Carcinoma

PD-L1 positive Non-Small Cell Lung Cancer

Recurrent Platinum-Resistant Ovarian Carcinoma

Squamous cell carcinoma of head and neck metastatic


Recombinant humanized monoclonal antibody against interleukin-6 receptor(Zhejiang Hisun)

Tocilizumab Biosimilar (Zhejiang Hisun Pharmaceutical Co., Ltd.)

托珠单抗生物类似药（Zhejiang Hisun Pharmaceutical Co., Ltd.）

Systemic onset juvenile chronic arthritis


CD19 positive Acute Lymphoblastic Leukemia


Ramucirumab (genetical recombination) (JAN)

Vascular endothelial growth factor receptor 2

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

PD-L1-positive head and neck squamous cell carcinoma

Recurrent Squamous Cell Carcinoma of the Head and Neck

HER2 positive Gastroesophageal Junction Adenocarcinoma

HER2-Low Gastroesophageal Junction Cancer

Microsatellite Instability-high Solid Tumors

Advanced Esophageal Squamous Cell Carcinoma

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Locally Advanced Unresectable Breast Carcinoma

Metastatic Gastroesophageal Junction Adenocarcinoma

Recurrent Platinum-Resistant Primary Peritoneal Carcinoma

Urothelial Carcinoma of the Urinary Bladder

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


disorder of bile acid and cholesterol metabolism

Inborn error in primary bile acid synthesis

United States
China
European Union
Japan
Iceland
South Korea
Liechtenstein
Norway


Mettreleptin (genetical recombination) (JAN)


Protein kinase AMP-activated non-catalytic subunit beta 1


Vonicog alfa (genetical recombination) (JAN)

United States
China
European Union
Japan
United Kingdom
Australia
Iceland
Liechtenstein
Norway


Locally Advanced Malignant Solid Neoplasm

Locally Advanced Lung Non-Small Cell Carcinoma

United States
China
United Kingdom
Canada
South Korea


Chemotherapy-induced nausea and vomiting


Ghrelin/growth hormone secretagogue receptor

Growth Hormone Deficiency With Pituitary Anomalies

European Union
Iceland
South Korea
Liechtenstein
Norway


Advanced Esophageal Squamous Cell Carcinoma

Estrogen receptor positive breast cancer

Refractory T Acute Lymphoblastic Leukemia

Philadelphia Chromosome Positive Acute Myeloid Leukemia

Philadelphia chromosome positive chronic myelogenous leukemia

BCR-ABL1 positive Acute Lymphoblastic Leukemia


Adrenoleucodystrophy gene therapy - bluebird bio

Elivaldogene tavalentivec - bluebird bio

Lenti-D adrenoleukodystrophy gene therapy

ATP Binding Cassette Subfamily D Member 1


Amlodipine Besilate/Atorvastatin Calcium Hydrate

Amlodipine Besylate/Atorvastatin Calcium Hydrate


SARS-CoV-2 Inactivated Vaccine(Sinovac Biotech)

Adsorbed COVID-19 Vaccine inactivated(Sinovac Biotech)

CoronaVac COVID-19 Vaccine (Vero Cell), Inactivated(Sinovac Biotech)

China
Hong Kong
Philippines
South Africa


Metastatic human epidermal growth factor 2 positive carcinoma of breast


United States
European Union
United Kingdom
Canada
Australia
Iceland
Liechtenstein
Norway


Squamous Cell Carcinoma of Head and Neck

Advanced Head and Neck Squamous Cell Carcinoma

Squamous cell carcinoma of the oral cavity recurrent

Squamous Cell Carcinoma of the Oropharynx


Idiopathic pulmonary arterial hypertension

Pulmonary arterial hypertension associated with connective tissue disease

Chronic thromboembolic pulmonary hypertension

United States
China
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Induced myeloid leukemia cell differentiation protein Mcl-1

Small molecule drug
Diagnostic radiopharmaceuticals


对乙酰氨基酚/马来酸氯苯那敏/盐酸伪麻黄碱/DL-甲基麻黄碱/氢溴酸右美沙芬水合物/愈创甘油醚/核黄素

Acetaminophen/Chlorpheniramine Maleate/Pseudoephedrine Hydrochloride/Methylephedrine Hydrochloride/Dextromethorphan Hydrobromide Hydrate/Guaifenesin/Vitamin B2


Chronic idiopathic thrombocytopenic purpura

Locally Advanced Malignant Solid Neoplasm

Metabolic dysfunction-associated steatotic liver disease


Dornase alfa biosimilar(Generium Pharmaceuticals)


C1 Esterase Inhibitor (Human) (ViroPharma)

AQP4-IgG positive Neuromyelitis optica spectrum disorder

United States
European Union
Iceland
Liechtenstein
Norway


MRSA - Methicillin resistant Staphylococcus aureus infection

United States
European Union
Canada
Iceland
Liechtenstein
Norway


Acetaminophen/Pseudoephedrine Hydrochloride/Guaifenesin/Diphenhydramine Hydrochloride/Riboflavin Sodium Phosphate


Coronavirus (COVID-19) mRNA vaccine(Walvax Biotechnology Co., Ltd.)


EGFR positive non-small cell lung cancer

Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer

EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer

Squamous Cell Carcinoma of Head and Neck

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

HPV positive oropharyngeal squamous cell carcinoma

Locally Advanced Head and Neck Squamous Cell Carcinoma

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Recurrent Squamous Cell Carcinoma of the Head and Neck

Renal Pelvis and Ureter Urothelial Carcinoma

Squamous cell carcinoma of head and neck metastatic

Transitional cell cancer of renal pelvis and ureter metastatic

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway
Taiwan Province


Ropeginterferon alfa 2b - AOP Orphan Pharmaceuticals/PharmaEssentia Corporation

Ropeginterferonum alfa 2b - AOP Orphan Pharmaceuticals/PharmaEssentia

mono-pegylated interferon - PharmaEssentia Corporation

BCR-ABL Negative Atypical Chronic Myeloid Leukemia

Locally Advanced Malignant Solid Neoplasm

Hepatitis B Virus-Related Hepatocellular Carcinoma

United States
China
European Union
Japan
Iceland
South Korea
Liechtenstein
Norway
Taiwan Province


Insulin Degludec (Genetical Recombination)

Insulin degludec (genetical recombination) (JAN)

United States
China
European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


Retinal vein occlusion-related macular edema


Interferon Beta-1b (genetical recombination)

Multiple Sclerosis, Secondary Progressive


Hepatitis C virus NS5B RNA-dependent RNA polymerase

United States
China
European Union
Japan
India
Iceland
Liechtenstein
Norway


Tumor necrosis factor ligand superfamily member 11

United States
European Union
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Eptacog Alfa (Activated) (Genetical Recombination)

Recombinant Human Coagulation Factor VIIa(Eptacog alfa, activated)

Recombinant Human Coagulation Factor VIIa(Eptacog alfa,activated)

Glanzmann Thrombasthenia, Autosomal Dominant

United States
China
European Union
Japan
Australia
Switzerland
Iceland
South Korea
Liechtenstein
Norway


China
European Union
Australia
Iceland
Liechtenstein
Norway


calcium voltage-gated channel subunit alpha1 A

China Japan Germany Spain France Greece Italy


Chronic Kidney Disease-Mineral and Bone Disorder

United States
China
European Union
Japan
Iceland
Liechtenstein
Norway


Moderate chronic obstructive pulmonary disease


Insulin Icodec (Genetical Recombination)/Semaglutide (Genetical Recombination)

China
European Union
Japan
Iceland
Liechtenstein
Norway


Y-branched pegylated recombinant human granulocyte colony stimulating factor


Lebrikizumab (genetical recombination) (JAN)

Chronic rhinosinusitis with nasal polyps

United States
European Union
Japan
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Trastuzumab biosimilar (Chia-tai Tianqing)

Metastatic human epidermal growth factor 2 positive carcinoma of breast


United States
China
European Union
Japan
Australia
Brazil
Iceland
Liechtenstein
Norway


European Union
Iceland
Liechtenstein
Norway


United States
China
European Union
Japan
United Kingdom
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Sarcoplasmic/endoplasmic reticulum calcium ATPase 1

Sarcoplasmic/endoplasmic reticulum calcium ATPase 2


Platelet-derived growth factor receptor alpha

Platelet-derived growth factor receptor beta

Vascular endothelial growth factor receptor 1

Vascular endothelial growth factor receptor 2

Vascular endothelial growth factor receptor 3

Advanced Pancreatic Neuroendocrine Tumor

Estrogen receptor positive breast cancer

Hormone receptor positive malignant neoplasm of breast

Human epidermal growth factor 2 negative carcinoma of breast

Locally Advanced Clear Cell Renal Cell Carcinoma

Metastatic castration-resistant prostate cancer

Metastatic Clear Cell Renal Cell Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

PDGFRA D842V mutation Gastrointestinal Stromal Tumors

Platinum-Resistant Primary Peritoneal Carcinoma

Recurrent Platinum-Resistant Fallopian Tube Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

Squamous Cell Carcinoma of Head and Neck

Squamous cell carcinoma of head and neck metastatic

thyroid gland poorly differentiated carcinoma

Unresectable Gastrointestinal Stromal Tumor

Urothelial Carcinoma of the Urinary Bladder

Well Differentiated Pancreatic Endocrine Tumor

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Anti-alpha4 integrin monoclonal antibody

Natalizumab (genetical recombination) (JAN)

Graft versus host disease in gastrointestinal tract

Multiple Sclerosis, Secondary Progressive

United States
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Neutropenia, Severe Congenital, Autosomal Recessive 3

Neutropenia, Nonimmune Chronic Idiopathic, Adult

Locally Advanced Clear Cell Renal Cell Carcinoma

Metastatic Triple-Negative Breast Carcinoma


聚乙二醇干扰素α-2b生物类似药(Zydus Cadila Healthcare Ltd.)

Peginterferon alpha-2b biosimilar(Zydus Cadila Healthcare Ltd.)


Denosumab Biosimilar (Shanghai Henlius Biotech, Inc.)

Recombinant human anti-RANKL antibody(Shanghai Henlius Biotech, Inc.)

Tumor necrosis factor ligand superfamily member 11

United States
European Union
United Kingdom
Canada
Iceland
Liechtenstein
Norway


AQP4-IgG positive Neuromyelitis optica spectrum disorder

United States
China
European Union
Japan
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Anti-CD20 monoclonal antibody ( Genentech)

Ocrelizumab (genetical recombination) (JAN)

United States
China
European Union
United Kingdom
Canada
Australia
United Arab Emirates
Switzerland
Iceland
South Korea
Liechtenstein
Norway


Synthetic peptide vaccine
Therapeutic vaccine


Human corneal endothelial cell therapy(Aurion Biotech)


mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches

United States
China
European Union
Japan
United Kingdom
Canada
Australia
Switzerland
Iceland
Liechtenstein
Norway


EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer

EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer

Metastatic Malignant Neoplasm to the Leptomeninges

EGFR positive non-small cell lung cancer

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma


Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene

Autologous CD34+ cells encoding βA-T87Q-globin gene

Autologous CD34+ cells transduced with TNS9.3.55

Beta globin transduced bone marrow cells

Gene therapy
Hematopoietic stem cell therapy


Refractory Acute Graft Versus Host Disease

Steroid Refractory Graft Versus Host Disease


Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

United States
European Union
United Kingdom
Switzerland
Iceland
Liechtenstein
Norway


Type 2 diabetes mellitus with established diabetic nephropathy

Heart failure with normal ejection fraction

Type 1 diabetes mellitus with established diabetic nephropathy

United States
China
European Union
Japan
United Kingdom
Canada
Australia
India
Iceland
South Korea
Liechtenstein
Norway


Breast Carcinoma Metastatic in the Liver

HER2 Positive Transitional Cell Carcinoma

HER2 positive Gastroesophageal Junction Adenocarcinoma

Advanced Gastroesophageal Junction Adenocarcinoma

HER2-expressing Gastroesophageal Junction Adenocarcinoma

HER2-Low Gastroesophageal Junction Cancer

Urothelial Carcinoma of the Urinary Bladder

HER2 positive Gastrooesophageal junction cancer

Renal Pelvis and Ureter Urothelial Carcinoma

Locally Advanced Unresectable Gastric Adenocarcinoma

HER2-Expressing Non-Muscle Invasive Bladder Neoplasms

Squamous Cell Carcinoma of Head and Neck

HER2 positive Invasive Bladder Carcinoma

Metastatic Carcinoma to the Uterine Cervix

Locally Advanced Malignant Solid Neoplasm

Hormone receptor positive HER2 negative breast cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Platinum-Resistant Primary Peritoneal Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma


Anti-Glomerular Basement Membrane Disease

Rapidly Progressive Glomerulonephritis With Pulmonary Hemorrhage

Thrombotic Thrombocytopenic Purpura, Acquired

European Union
Australia
Israel
Iceland
Liechtenstein
Norway


Type 2 diabetes mellitus with established diabetic nephropathy


United Kingdom
Belgium
Switzerland
Germany
Denmark
Spain
France
Italy
Luxembourg
South Africa


Extramedullary Disease in Multiple Myeloma


Sleep Initiation and Maintenance Disorders

United States
China
Japan
Canada
Austria
Belgium
Czechia
Germany
Spain
Finland
France
Greece
Hong Kong
Hungary
Ireland
Italy
Netherlands
Poland
Portugal


SARS-CoV-2 protein subunit vaccine (Razi Vaccine and Serum Research Institute)


Mixed Protamine Human Insulin (30R)(HEC Pharm)


Estrogen receptor positive breast cancer

HER2 positive Gastrooesophageal junction cancer

Hormone receptor positive HER2 positive breast cancer

Metastatic Malignant Neoplasm to the Leptomeninges

Locally Advanced Malignant Solid Neoplasm

Metastatic HER2 positive gastroesophageal junction cancer

Platinum-Resistant Fallopian Tube Carcinoma

progesterone receptor-negative breast cancer

Recurrent Platinum-Resistant Ovarian Carcinoma


United States
China
European Union
Iceland
Liechtenstein
Norway


Small intestine transplantation rejection

Blastic Plasmacytoid Dendritic Cell Neoplasm

Refractory Adult Acute Lymphoblastic Leukemia

Anemia, Refractory, With Excess of Blasts

Philadelphia chromosome positive chronic myelogenous leukemia

Refractory Acute Undifferentiated Leukemia

Philadelphia positive acute lymphocytic leukaemia

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Recurrent Adult Acute Lymphoblastic Leukemia

Blast Phase Chronic Granulocytic Leukemia

Aggressive-Phase Chronic Myelocytic Leukemia

Recurrent Childhood Acute Lymphoblastic Leukemia

Acute myeloid leukaemia with 11q23 abnormality

Acute myeloid leukemia with multilineage dysplasia

Acute Myeloid Leukemia with Myelodysplasia-Related Changes

Adult acute myeloid leukemia with del(5q)

Childhood Nodular Sclerosis Classic Hodgkin Lymphoma

Chronic lymphocytic leukaemia refractory

pediatric lymphoblastic non-Hodgkin's lymphoma

Primary Cutaneous Anaplastic Large Cell Lymphoma

Recurrent Adult Grade III Lymphomatoid Granulomatosis

Recurrent Aggressive Non-Hodgkin Lymphoma

Recurrent Anaplastic Large Cell Lymphoma

Recurrent High-Grade B-Cell Lymphoma with MYC and BCL2 or BCL6 Rearrangements

Refractory B Acute Lymphoblastic Leukemia

Refractory cytopenia with multilineage dysplasia and ringed sideroblasts

Secondary Central Nervous System Lymphoma

Stage II Non-Contiguous Adult Diffuse Small Cleaved Cell Lymphoma

Treatment related acute myeloid leukaemia

untreated pediatric acute nonlymphocytic leukemia

United States
China
European Union
Japan
Australia
Brazil
Iceland
South Korea
Liechtenstein
Norway


Inactivated SARS-CoV-2 vaccine (Vero cell)(Wuhan Institute of Biological Products Co., Ltd.)


Cytotoxic T-Lymphocyte-Associated Antigen 4

Mismatch repair-deficient Colonic Cancer

Locally Advanced Lung Non-Small Cell Carcinoma

PD-L1 positive Non-squamous non-small cell lung cancer

Squamous cell carcinoma of the oral cavity

Locally Advanced Unresectable Gastric Adenocarcinoma

CLDN18.2 Positive Advanced Malignant Solid Neoplasm

Locally Advanced Malignant Solid Neoplasm

Metastatic Carcinoma to the Uterine Cervix

Locally Advanced Esophageal Squamous Cell Carcinoma


United States
European Union
Japan
United Kingdom
Canada
Iceland
Liechtenstein
Norway


Polyarticular Juvenile Idiopathic Arthritis

United States
European Union
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


CD-30 positive Peripheral T-Cell Lymphoma

Refractory Indolent Non-Hodgkin Lymphoma

Peripheral T-cell lymphoma unspecified refractory


Isocitrate dehydrogenase [NADP] cytoplasmic

Diffuse midline glioma, point mutation K27M in histone H3

CCUS Clonal Cytopenia of Undetermined Significance


Xylometazoline Hydrochloride Nasal Drops

Xylometazoline Hydrochloride Nasal Spray

Xylometazoline Hydrochloride Nasdl Spray


United States
European Union
Iceland
Liechtenstein
Norway


United Kingdom
Austria
Belgium
Bulgaria
Cyprus
Czechia
Germany
Denmark
Estonia
Spain
Finland
France
Greece
Croatia
Hungary
Ireland
Italy
Lithuania
Luxembourg
Latvia
Malta
Netherlands
Poland
Portugal
Romania
Sweden
Slovenia
Slovakia


United States
China
Japan
Brazil
South Korea


对乙酰氨基酚/马来酸氯苯那敏/氢溴酸右美沙芬水合物/愈创甘油醚/盐酸那可汀水合物/丁酸核黄素/盐酸呋喃硫胺

Acetaminophen/Chlorpheniramine Maleate/Dextromethorphan Hydrobromide Hydrate/Guaifenesin/Noscapine Hydrochloride Hydrate/Riboflavin Butyrate/Fursultiamine Hydrochloride


Platelet-derived growth factor receptor alpha

Metastatic Gastrointestinal Stromal Tumor

Unresectable Gastrointestinal Stromal Tumor

PDGFRA D842V mutation Gastrointestinal Stromal Tumors

PDGFRA Exon 18 Mutation-Positive Gastrointestinal Stromal Tumor

United States
China
European Union
United Kingdom
Canada
Hong Kong
Iceland
Liechtenstein
Norway
Taiwan Province


EGFR ex20ins mutation in non-small cell lung cancer

EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer

EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

EGFR positive Non-squamous non-small cell lung cancer

EGFR positive non-small cell lung cancer

Locally Advanced Lung Non-Small Cell Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma


United States
China
European Union
United Kingdom
Canada
Switzerland
Hong Kong
Iceland
Liechtenstein
Norway
Russia


Proto-oncogene tyrosine-protein kinase ROS

Reactive oxygen species 1 positive non-small cell lung cancer

ALK-positive anaplastic large cell lymphoma

Diffuse midline glioma, point mutation K27M in histone H3

United States
China
European Union
Japan
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Peroxisome proliferator-activated receptor α


Locally Advanced Pancreatic Adenocarcinoma

United States
China
European Union
Japan
Canada
Australia
Switzerland
Iceland
Liechtenstein
Norway
Saudi Arabia
Thailand


Metastatic Carcinoma to the Uterine Cervix

Urothelial Carcinoma of the Urinary Bladder


Teriparatide biosimilar(Theramex Ireland Limited)

European Union
Iceland
Liechtenstein
Norway


Bevacizumab biosimilar(Hualan Genetic Engineering)

Bevacizumab Biosimilar (Hualan Genetic Engineering Co., Ltd.)

贝伐珠单抗生物类似药（Hualan Genetic Engineering Co., Ltd.）


Somatostatin Receptor-Positive Neuroendocrine Tumor

Peptide Conjugate Radionuclide
Diagnostic radiopharmaceuticals


Calcium release-activated calcium channel protein 1


China
Hong Kong
Malaysia
Singapore
Taiwan Province


Mequitazine/Atropa belladonna extract/Glycyrrhizinate dipotassium/Pseudoephedrine Hydrochloride/Caffeine

Corticosteroid 11-beta-dehydrogenase isozyme 1


Rasburicase (genetical recombination) (JAN)

Blast Phase Chronic Granulocytic Leukemia

United States
China
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Sleep Initiation and Maintenance Disorders


Heart failure with normal ejection fraction

Heart failure with reduced ejection fraction

China Argentina Austria Cyprus Spain Finland Greece Iceland Italy Norway Portugal Sweden


Reduced ejection fraction co-occurrent and due to chronic heart failure


Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma

Anemia, Refractory, With Excess of Blasts

CD20 Positive B-Cell Chronic Lymphocytic Leukemia

Chronic lymphocytic leukaemia refractory

Recurrent Anaplastic Large Cell Lymphoma

Recurrent High-Grade B-Cell Lymphoma with MYC and BCL2 or BCL6 Rearrangements

Recurrent Transformed B-Cell Non-Hodgkin Lymphoma

Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Refractory Indolent Non-Hodgkin Lymphoma

T-cell/histiocyte rich large B-cell lymphoma

United States
China
Japan
Canada
Australia
Austria
Belgium
Bulgaria
Germany
Spain
Italy
Luxembourg
Netherlands
Portugal
Slovakia


United States
China
Canada
Australia
United Arab Emirates


UM171-Expanded Cord Blood Transplantation

Hematopoietic progenitor cell antigen CD34


Exon 53 specific antisense morpholino oligonucleotide

Duchenne Muscular Dystrophy Exon 53 Skipping Mutation


United States
European Union
United Kingdom
Canada
Switzerland
Iceland
Liechtenstein
Norway


United States
China
European Union
Australia
Iceland
South Korea
Liechtenstein
Norway


Erosive gastro-esophageal reflux disease


United States
European Union
Japan
United Kingdom
Iceland
South Korea
Liechtenstein
Norway


Multiple Pterygium Syndrome, Autosomal Dominant

Non Functioning Pancreatic Endocrine Tumor

United States
China
Japan
Australia
South Korea


2-(4-(4-Chlorobenzoyl)phenoxy)-2-methylpropanoic acid 1-methylethyl ester

Peroxisome proliferator-activated receptor α

Retinal Dystrophy With Inner Retinal Dysfunction and Ganglion Cell Abnormalities

Chylomicronemia, Familial, Due to Circulating Inhibitor of Lipoprotein Lipase

United States
China
Japan
Australia
France
South Korea


Polyarticular Juvenile Idiopathic Arthritis

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Blast Phase Chronic Granulocytic Leukemia

Interstitial lung disease due to systemic disease

Rheumatoid arthritis with rheumatoid lung disease

Steroid Refractory Graft Versus Host Disease

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


PD-L1 positive Non-Small Cell Lung Cancer

Locally Advanced Lung Non-Small Cell Carcinoma


Metastatic castration-resistant prostate cancer


Benralizumab (genetical recombination) (JAN)

Chronic rhinosinusitis with nasal polyps

Severe chronic obstructive pulmonary disease

United States
China
European Union
Japan
Canada
Australia
Switzerland
Iceland
South Korea
Liechtenstein
Norway


Insulin aspart Biosimilar (Jilin Huisheng Biological Pharmaceutical Co., Ltd.)

Insulin aspart(Jilin Jinsheng Pharmaceutical Co. Ltd.)

门冬胰岛素生物类似药（Jilin Huisheng Biological Pharmaceutical Co., Ltd.）


Sleep Initiation and Maintenance Disorders


Voltage-gated N-type calcium channel alpha-1B subunit

United States
China
Japan
United Kingdom
Canada


Dementia due to Alzheimer's disease (disorder)


Ventilator associated bacterial pneumonia

Infection due to carbapenem resistant Acinetobacter


Hepatitis C virus NS5B RNA-dependent RNA polymerase


Atezolizumab (genetical recombination) (JAN)

PD-L1 positive Triple Negative Breast Cancer

Advanced Triple-Negative Breast Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Metastatic Triple-Negative Breast Carcinoma

Hormone receptor positive HER2 negative breast cancer

Unresectable Esophageal Squamous Cell Carcinoma

Metastatic Carcinoma to the Uterine Cervix

Recurrent Triple-Negative Breast Carcinoma

Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Squamous Cell Carcinoma of Head and Neck

Metastatic Pancreatic Ductal Adenocarcinoma

Squamous cell carcinoma of the oral cavity

Platinum-Resistant Fallopian Tube Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma

PD-L1 positive Non-squamous non-small cell lung cancer

Small cell neuroendocrine carcinoma of bladder

Metastatic Microsatellite Stable Colorectal Carcinoma

Locally Advanced Hepatocellular Carcinoma

Large cell neuroendocrine carcinoma of lung

Microsatellite instability-high colorectal cancer

Metastatic Esophageal Squamous Cell Carcinoma

HER2-expressing Gastroesophageal Junction Adenocarcinoma

HER2 positive Gastroesophageal Junction Adenocarcinoma

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Resectable Lung Non-Small Cell Carcinoma

Locally Advanced Malignant Solid Neoplasm

Muscle Invasive Bladder Urothelial Carcinoma

Advanced Esophageal Squamous Cell Carcinoma

Advanced Head and Neck Squamous Cell Carcinoma

Cancer with a high tumour mutational burden

Diffuse large B-cell lymphoma refractory

EGFR positive Non-squamous non-small cell lung cancer

Estrogen receptor positive breast cancer

HPV positive oropharyngeal squamous cell carcinoma

Human epidermal growth factor 2 negative carcinoma of breast

Human Papillomavirus-Related Oropharyngeal Neoplasms

Human Papillomavirus-Related Squamous Cell Carcinoma

Locally Advanced Clear Cell Renal Cell Carcinoma

Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck

Malignant neoplasm of gastro-oesophageal junction

Metastatic castration-resistant prostate cancer

Metastatic Clear Cell Renal Cell Carcinoma

Philadelphia chromosome positive chronic myelogenous leukemia

Primary Peritoneal Serous Adenocarcinoma

Recurrent Squamous Cell Carcinoma of the Head and Neck

Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Renal Pelvis and Ureter Urothelial Carcinoma

Squamous cell carcinoma of head and neck metastatic

Squamous Cell Carcinoma of the Oropharynx

Transitional cell cancer of renal pelvis and ureter metastatic

United States
China
European Union
Japan
United Kingdom
Canada
Australia
Iceland
Liechtenstein
Norway


Acute myeloid leukemia with mutated NPM1

Acute Leukemia with a KMT2A Translocation

Refractory Acute Undifferentiated Leukemia


Sutimlimab (genetical recombination) (JAN)

United States
European Union
Japan
Iceland
South Korea
Liechtenstein
Norway


Urothelial Carcinoma of the Urinary Bladder

European Union
Israel
Iceland
Liechtenstein
Norway


Potassium two pore domain channel subfamily K


Attention Deficit Disorder With Hyperactivity


Adalimumab biosimilar (Junshi Biosciences)

Polyarticular Juvenile Idiopathic Arthritis


Heart failure with normal ejection fraction


United States
China
European Union
Japan
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Proto-oncogene tyrosine-protein kinase ROS

Neurotrophic tyrosine kinase receptor type 2

Vascular endothelial growth factor receptor 1

Vascular endothelial growth factor receptor 2

Vascular endothelial growth factor receptor 3

Well Differentiated Pancreatic Endocrine Tumor

Refractory Differentiated Thyroid Gland Carcinoma

Metastatic Urethral Urothelial Carcinoma

Sarcomatoid Transitional Cell Carcinoma of the Renal Pelvis

Advanced Pancreatic Neuroendocrine Tumor

Metastatic Digestive System Neuroendocrine Tumor G1

Metastatic Thymic Neuroendocrine Neoplasm

Non Functioning Pancreatic Endocrine Tumor

Pancreatic neuroendocrine tumour metastatic

Metastatic castration-resistant prostate cancer

Recurrent Pharyngeal Squamous Cell Carcinoma

Squamous cell carcinoma of head and neck metastatic

Metastatic Esophageal Squamous Cell Carcinoma

Metastatic Microsatellite Stable Colorectal Carcinoma

thyroid gland poorly differentiated carcinoma

Malignant neoplasm of gastro-oesophageal junction

Metastatic Clear Cell Renal Cell Carcinoma

Locally Advanced Clear Cell Renal Cell Carcinoma

Muscle Invasive Bladder Urothelial Carcinoma

Small cell neuroendocrine carcinoma of bladder

Recurrent Squamous Cell Carcinoma of the Head and Neck

Relapsed Squamous Cell Carcinoma of the Larynx

Squamous cell carcinoma of the hypopharynx

Squamous cell carcinoma of the oral cavity recurrent

Squamous Cell Carcinoma of the Oropharynx

Squamous cell carcinoma of the paranasal sinus

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

Metastatic Malignant Neoplasm to the Leptomeninges

Refractory Central Nervous System Lymphoma

RET fusion-positive Non-Small Cell Lung Cancer

Somatostatin Receptor-Positive Neuroendocrine Tumor

Advanced Thyroid Gland Medullary Carcinoma

Advanced Triple-Negative Breast Carcinoma

Metastatic Thyroid Gland Medullary Carcinoma

Metastatic Triple-Negative Breast Carcinoma

Recurrent Triple-Negative Breast Carcinoma

Locally Advanced Malignant Solid Neoplasm

Fallopian Tube Clear Cell Adenocarcinoma

Locally Advanced Hepatocellular Carcinoma

MET gene amplification Non-small Cell Lung Cancer

Metastatic Carcinoma to the Uterine Cervix

Metastatic human epidermal growth factor 2 positive carcinoma of breast

recurrent primary peritoneal cavity cancer

RET fusion-positive  Adenocarcinoma of Lung

United States
European Union
Japan
United Kingdom
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Proprotein convertase subtilisin kexin type 9


PD-L1 positive Triple Negative Breast Cancer

Metastatic Gastroesophageal Junction Adenocarcinoma

Resectable Lung Non-Small Cell Carcinoma

Cirrhosis, Familial, With Pulmonary Hypertension

Hormone receptor positive HER2 negative breast cancer

Unresectable Lung Non-Small Cell Carcinoma

Hormone receptor positive HER2 positive breast cancer

Recurrent Squamous Cell Carcinoma of the Head and Neck

Locally Advanced Lung Non-Small Cell Carcinoma

Advanced Pancreatic Ductal Adenocarcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

Squamous Cell Carcinoma of Head and Neck

HER2-expressing Gastroesophageal Junction Adenocarcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Locally Advanced Esophageal Squamous Cell Carcinoma


Diprophy lline and Sodium chloride lnjection

Phosphodiesterases, 3',5'-cyclic nucleotide (PDEs)


Sodium channel protein type V alpha subunit

Heart failure with normal ejection fraction

Hypertrophic Cardiomyopathy without Obstruction

Non ST segment elevation acute coronary syndrome

United Kingdom
Canada
Australia
Switzerland
South Korea


Recombinant staphylokinase(Jilin Yujin Pharmaceutical Co Ltd)


Bevacizumab biosimilar(Sino Cell Technologies)

Recombinant humanized anti-VEGF monoclonal antibody(Sinocelltech Group)


EGFR ex20ins mutation in non-small cell lung cancer

Locally Advanced Lung Non-Small Cell Carcinoma


United States
European Union
Canada
Iceland
Liechtenstein
Norway


Platinum-Resistant Fallopian Tube Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma

Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck

Locally Advanced Malignant Solid Neoplasm

Refractory High Risk Myelodysplastic Syndrome

Steroid Refractory Graft Versus Host Disease

United States
European Union
Australia
Ecuador
Iceland
Liechtenstein
Mexico
Norway


Vascular endothelial growth factor receptor

Advanced Pancreatic Neuroendocrine Tumor

Advanced Gastroesophageal Junction Adenocarcinoma

Well Differentiated Pancreatic Endocrine Tumor

Advanced Thyroid Gland Medullary Carcinoma

Neuroendocrine neoplasm of gastrointestinal tract

Refractory Differentiated Thyroid Gland Carcinoma


United States
China
European Union
Japan
United Kingdom
Iceland
South Korea
Liechtenstein
Norway


Metastatic human epidermal growth factor 2 positive carcinoma of breast

Estrogen receptor positive breast cancer


Non ST segment elevation acute coronary syndrome

United States
China
European Union
Japan
Australia
Brazil
Iceland
Liechtenstein
Norway


Insulin Degludec biosimilar (Huisheng Biological)

Insulin degludec Biosimilar (Jilin Huisheng Biological Pharmaceutical Co., Ltd.)

德谷胰岛素生物类似药（Jilin Huisheng Biological Pharmaceutical Co., Ltd.）


progressive familial intrahepatic cholestasis

Cholestasis, Progressive Familial Intrahepatic 2

Cholestasis, Progressive Familial Intrahepatic 1

United States
China
European Union
Japan
United Kingdom
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Epidermolysis Bullosa Dystrophica, Pasini Type


c-Met positive non-squamous non-small cell lung cancer

c-Met positive non-small cell lung cancer

Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma


Attention Deficit Disorder With Hyperactivity


Immunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer

Microsatellite instability-high Endometrial Carcinoma

Mismatch repair-deficient Endometrial Carcinoma

PD-L1 positive Non-Small Cell Lung Cancer

Locally Advanced Head and Neck Squamous Cell Carcinoma

Mismatch repair-deficient Colonic Cancer

Metastatic Carcinoma to the Uterine Cervix

Microsatellite instability-high Rectal Cancer

Recurrent Squamous Cell Carcinoma of the Head and Neck

Squamous Cell Carcinoma of Head and Neck

Microsatellite instability-high colorectal cancer

United States
European Union
Australia
Iceland
South Korea
Liechtenstein
Norway
Singapore


Canakinumab (genetical recombination) (JAN)

Neonatal-Onset Multisystem Inflammatory Disease

Systemic onset juvenile chronic arthritis

Periodic Fever, Familial, Autosomal Dominant

Locally Advanced Lung Non-Small Cell Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

Proliferative retinopathy with diabetes mellitus

Resectable Lung Non-Small Cell Carcinoma

United States
European Union
Japan
Canada
Australia
Switzerland
Iceland
South Korea
Liechtenstein
Norway


Vascular endothelial growth factor receptor 1

Vascular endothelial growth factor receptor 2

Vascular endothelial growth factor receptor 3

Metastatic Clear Cell Renal Cell Carcinoma

Locally Advanced Clear Cell Renal Cell Carcinoma


Olaratumab (genetical recombination) (JAN)

Platelet-derived growth factor receptor alpha

Metastatic Gastrointestinal Stromal Tumor

Unresectable Gastrointestinal Stromal Tumor


Ofatumumab (genetical recombination) (JAN)

CD20 Positive B-Cell Chronic Lymphocytic Leukemia

Chronic lymphocytic leukaemia refractory

Multiple Sclerosis, Secondary Progressive

Recurrent High-Grade B-Cell Lymphoma with MYC and BCL2 or BCL6 Rearrangements

Recurrent Transformed B-Cell Non-Hodgkin Lymphoma

T-cell/histiocyte rich large B-cell lymphoma

United States
China
European Union
Japan
Canada
Iceland
Liechtenstein
Norway


Calcium release-activated calcium channel protein 1


Peripheral T-cell lymphoma unspecified recurrent

Peripheral T-cell lymphoma unspecified refractory

CD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma


Hormone receptor positive HER2 negative breast cancer

Prostate Adenocarcinoma with Neuroendocrine Differentiation


Calcitonin gene-related peptide type 1 receptor

United States
European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


Polyarticular Juvenile Idiopathic Arthritis

European Union
Japan
Iceland
South Korea
Liechtenstein
Norway


Certolizumab Pegol (Genetical Recombination)

Certolizumab pegol (genetical recombination) (JAN)

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Human Anti-Tetanus Immunoglobulin (Xinjiang Deyuan)


Leukocyte adhesion glycoprotein LFA-1 alpha

United States
Canada
Australia
Switzerland
South Korea


Eculizumab Biosimilar (Samsung Bioepis Co., Ltd.)

Eculizumab biosimilar (AffaMed Therapeutics)

United States
European Union
Iceland
Liechtenstein
Norway


Calcipotriol and Betamethasone Dipropionate Gel


Metastatic Pancreatic Ductal Adenocarcinoma


Interferon alfa-2b biosimilar(Changchun Institute of Biological Products)

Philadelphia chromosome positive chronic myelogenous leukemia


Amlodipine Besylate/Fimasartan Potassium Trihydrate/Rosuvastatin Calcium


Freeze-d r i e d P o l y e t h y l e ne Glycol Treated Human Normal Immunoglobulin

Freeze-dried ion-exchange-resin treatedhuman normalimmunoglobulin

Human Immune Globulin for Subcutaneous Administration

Immune globulin infusion 10% [human] with recombinant human hyaluronidase

pH4-Treated Acidic Normal Human Immunoglobulin

ｐＨ４処理酸性人免疫グロブリン（皮下注射）・ボルヒアルロニダーゼ　アルファ（遺伝子組換え）

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

AQP4-IgG positive Neuromyelitis optica spectrum disorder

Chronic idiopathic thrombocytopenic purpura

United States
European Union
Japan
Canada
Australia
Czechia
Germany
Estonia
France
Iceland
Liechtenstein
Lithuania
Norway
Portugal
Slovenia


Insulin aspart/insulin protamine aspart(Novo Nordisk)


Ciprfloxacin Lactate and Sodium Chloride

Ciprofloxacin Lactate and Sodium Chioride

Ciprofloxacin Lactate and Sodium Chloride

CiprofloxacinLactateand and Sodium Chloride

Ciprofloxacini Lactate and Sodium Chloride

Ciproflxoacin Lactate and Sodium Chloride

Non-complicated skin and skin structure infection


Sleep Initiation and Maintenance Disorders

Squamous Cell Carcinoma of Head and Neck

United Kingdom
Australia
Austria
Belgium
Czechia
Germany
Denmark
Spain
Finland
France
Ireland
Iceland
Italy
Luxembourg
Netherlands
Norway
Poland
Portugal
Sweden
Slovakia


Associated Pulmonary Arterial Hypertension

Idiopathic pulmonary arterial hypertension

United States
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Hepatitis C virus serine protease, NS3/NS4A


Proto-oncogene tyrosine-protein kinase ROS

Neurotrophic tyrosine kinase receptor type 2

Neurotrophic tyrosine kinase receptor type 3

Reactive oxygen species 1 positive non-small cell lung cancer

Locally Advanced Lung Non-Small Cell Carcinoma

Estrogen receptor positive breast cancer

Locally Advanced Malignant Solid Neoplasm

United States
China
European Union
Japan
Canada
Australia
Hong Kong
Israel
Iceland
South Korea
Liechtenstein
Norway
New Zealand


Irritable bowel syndrome with constipation

Metabolic dysfunction-associated steatotic liver disease


Refractory Indolent Non-Hodgkin Lymphoma

European Union
Iceland
Liechtenstein
Norway


Steroid Refractory Graft Versus Host Disease


Recombinant epidermal growth factor drop(Guilin Pavay Gene Pharmaceutical)


c-Met positive non-small cell lung cancer

MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer

EGFR mutation MET positive Non-small Cell Lung Cancer

c-Met positive Adenocarcinoma of Esophagus

MET gene amplification Non-small Cell Lung Cancer

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Advanced Gastroesophageal Junction Adenocarcinoma


Electron transport chain complex proteins

China
European Union
Iceland
South Korea
Liechtenstein
Norway


ATP Binding Cassette Subfamily D Member 1


Coagulation factor VIIa (recombinant)-jncw(LFB Biotechnologies SASU)

United States
European Union
Iceland
Liechtenstein
Mexico
Norway


Acetaminophen/DL-Methylephedrine Hydrochloride/Tipepidine Citrate/Riboflavin/Chlorpheniramine Maleate


United States
European Union
Japan
Iceland
Liechtenstein
Norway


Brodalumab (genetical recombination) (JAN)

Drug-Related Side Effects and Adverse Reactions

United States
China
European Union
Japan
Canada
Iceland
Liechtenstein
Norway
Taiwan Province


Clostridium botulinum toxin type A(PharmaResearch BIO)


Proliferative retinopathy with diabetes mellitus

Retinal vein occlusion-related macular edema


Recombinant human coagulation factor VIIa (ChiaTai Tianqing)


Ondansetron Hydrochloride and Sodium Chloride

Ondansetron hydrochloride hydrate (JAN/USP)

5-hydroxytryptamine receptors, ionotropic (HTR3)

Chemotherapy-induced nausea and vomiting

Metabolic dysfunction-associated steatotic liver disease


Pegfilgrastim  Biosimilar (Curateq Biologics Pvt Ltd.)

European Union
Canada
Iceland
Liechtenstein
Norway


Cetuximab Biosimilar (Sichuan Kelun Botai Biomedicine Co., Ltd.)

Squamous Cell Carcinoma of Head and Neck

KRAS G12C mutant Non-small Cell Lung Cancer


China Azerbaijan Ecuador Cambodia Kazakhstan


Atorvastatin Calcium Hydrate/Omega-3-Acid Ethyl Esters 90


United Kingdom
Austria
Estonia
Finland
France
Greece
Hungary
Italy
Lithuania
Latvia
Portugal


Diffuse large B-cell lymphoma refractory

Philadelphia chromosome positive chronic myelogenous leukemia

United States
China
European Union
Japan
Canada
Australia
France
Iceland
South Korea
Liechtenstein
Norway


ATPase secretory pathway Ca2+ transporting 1

gamma-aminobutyric acid type A receptor subunit alpha1

glutamate ionotropic receptor AMPA type subunit 1


ARQ 252 Active Ingredient (Jiangsu Hengrui)

PD-L1-positive head and neck squamous cell carcinoma

Recurrent Squamous Cell Carcinoma of the Head and Neck


Bullous Dystrophy, Hereditary Macular Type


Recombinant human anti-PD-1 monoclonal antibody(CSPC Zhongqi)

Metastatic Esophageal Squamous Cell Carcinoma

Squamous cell carcinoma of head and neck metastatic

Advanced Triple-Negative Breast Carcinoma

Platinum-Resistant Epithelial Ovarian Carcinoma

HER2 positive Gastroesophageal Junction Adenocarcinoma

Locally Advanced Malignant Solid Neoplasm

CLDN18.2 positive  Gastroesophageal junction adenocarcinoma

CLDN18.2 positive  stomach adenocarcinoma

Locally Advanced Esophageal Squamous Cell Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma


European Union
Brazil
Iceland
South Korea
Liechtenstein
Norway
Russia


Ranibizumab biosimilar (Midas Pharma GmbH)

Ranibizumab  Biosimilar (Midas Pharma GmbH)

Proliferative retinopathy with diabetes mellitus

Retinal vein occlusion-related macular edema


Voltage-gated N-type calcium channel alpha-1B subunit

United States
European Union
Switzerland
Iceland
Liechtenstein
Norway


Dual specificity mitogen-activated protein kinase kinase 1

Dual specificity mitogen-activated protein kinase kinase 2

Childhood Central Nervous System Neoplasm

Refractory Central Nervous System Lymphoma

Recurrent Childhood Acute Lymphoblastic Leukemia

Anemia, Refractory, With Excess of Blasts

Adenocarcinoma of gallbladder with squamous metaplasia

Colorectal Cancer, Hereditary Nonpolyposis, Type 1

Locally Advanced Lung Non-Small Cell Carcinoma

Locally Advanced Malignant Solid Neoplasm

Malignant neoplasm of gastro-oesophageal junction

Metastatic Triple-Negative Breast Carcinoma

Recurrent Adult Acute Lymphoblastic Leukemia

recurrent ovarian tumors of low malignant potential

Recurrent Primary Peritoneal Low Grade Serous Adenocarcinoma

Refractory Differentiated Thyroid Gland Carcinoma

T-cell acute lymphoblastic leukemia in relapse

thyroid gland poorly differentiated carcinoma

United States
China
European Union
Japan
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Recombiant Fully Human Anti-RANKL Monoclonal Antibody (Jiangsu T-Mab Biopharma)

Tumor necrosis factor ligand superfamily member 11


Type 2 diabetes mellitus with established diabetic nephropathy

Metastatic castration-resistant prostate cancer


Retinal vein occlusion-related macular edema


EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer

EGFR positive Non-squamous non-small cell lung cancer


EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

EGFR positive non-small cell lung cancer

Unresectable Lung Non-Small Cell Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

EGFR mutation MET positive Non-small Cell Lung Cancer

Metastatic Malignant Neoplasm to the Leptomeninges

China
European Union
United Kingdom
Iceland
Liechtenstein
Norway


basic helix-loop-helix family member e40

Advanced Pancreatic Ductal Adenocarcinoma

Microsatellite instability-high colorectal cancer

Hepatitis B Virus-Related Hepatocellular Carcinoma


Ghrelin/growth hormone secretagogue receptor


Chromosome 8p11 myeloproliferative syndrome

FGFR2 fusion or rearranged Cholangiocarcinoma

FGFR2 positive Intrahepatic Cholangiocarcinoma

SDH-deficient Gastrointestinal Stromal Tumors

Core binding factor acute myeloid leukemia

Infantile Convulsions and Paroxysmal Choreoathetosis, Familial

Locally Advanced Malignant Solid Neoplasm

Urothelial Carcinoma of the Urinary Bladder

United States
China
European Union
Japan
Canada
Australia
Iceland
South Korea
Liechtenstein
Macao
Norway


Hormone receptor positive HER2 negative breast cancer

Metastatic HER2-Negative Breast Carcinoma

Estrogen receptor positive breast cancer

Hormone Receptor Positive Breast Adenocarcinoma

HR Positive/HER2 Negative/Node positive breast cancer


United States
China
European Union
Canada
Iceland
South Korea
Liechtenstein
Norway


United States
European Union
United Kingdom
Canada
Israel
Iceland
Liechtenstein
Norway
Taiwan Province


Bevacizumab biosimilar (Chia-tai Tianqing)


Recombinant COVID-19  XBB.1.5 Vaccine (Adenovirus type 5 vector) (CanSino Biotech)


United States
Japan
Australia
South Korea


Thyroid Hormone Resistance, Selective Pituitary

European Union
France
Iceland
Liechtenstein
Norway


Factor VIII (Guangdong Shuanglin Biological Pharmaceutical)


Recombinant human thrombopoietin mimetic-fusion protein(Qilu Pharma)

Romiplostim Biosimilar (Qilu Pharmaceutical Co., Ltd.)

Chronic idiopathic thrombocytopenic purpura


Von Willebrand factor/coagulation factor VIII complex(Octapharma AG)

Factor VIII/von Willebrand factor(Octapharma)

United States
United Kingdom
Austria
Belgium
Bulgaria
Cyprus
Czechia
Germany
Denmark
Estonia
Spain
Finland
France
Croatia
Hungary
Ireland
Italy
Lithuania
Luxembourg
Latvia
Malta
Netherlands
Norway
Poland
Portugal
Romania
Sweden
Slovenia
Slovakia


Indacaterol Maleate and Glycopyrronium Bromide

China
European Union
Japan
Iceland
Liechtenstein
Norway


Sodium voltage-gated channel alpha subunits

United States
China
European Union
Iceland
Liechtenstein
Norway


Calcitonin gene-related peptide type 1 receptor

Chronic rhinosinusitis without nasal polyps

United States
China
European Union
Japan
Canada
Australia
India
Iceland
South Korea
Liechtenstein
Norway


Articaine Hydrochloride and Epinephrine Tartrate

United States
China
Japan
Australia
Germany


United States
China
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Ripasudil Hydrochloride Hydrate/Brimonidine Tartrate

Ripasudil hydrochloride hydrate/brimonidine tartrate(Kowa)


HRR Gene-mutated Castration-Resistant Prostate Cancer

Metastatic castration-resistant prostate cancer

Advanced Triple-Negative Breast Carcinoma

Estrogen receptor positive breast cancer

Locally Advanced Head and Neck Squamous Cell Carcinoma

Squamous Cell Carcinoma of Head and Neck

Squamous cell carcinoma of head and neck metastatic


Platelet-derived growth factor receptor beta

Vascular endothelial growth factor receptor 1

Vascular endothelial growth factor receptor 2

Vascular endothelial growth factor receptor 3

Fallopian Tube High Grade Serous Adenocarcinoma

Metastatic Clear Cell Renal Cell Carcinoma

Platinum-Sensitive Primary Peritoneal Carcinoma

United States
European Union
Iceland
Liechtenstein
Norway


Anti-HER2 monoclonal antibody (Shanghai Henlius Biotech)

Pertuzumab Biosimilar (Shanghai Henlius Biotech, Inc.)

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Hormone receptor negative HER2 positive breast cancer


PSMA-Positive Castration-Resistant Prostatic Cancer

Metastatic castration-resistant prostate cancer

Diffuse midline glioma, point mutation K27M in histone H3

Peptide Conjugate Radionuclide
Therapeutic radiopharmaceuticals


Antihemophilic factor (recombinant), PEGylated-aucl(Bayer HealthCare)

Damoctocog Alfa Pegol (Genetical Recombination)

Damoctocog alfa pegol (genetical recombination) (JAN)

PEGylated B-Domain-Delted Recombinant FVIII

United States
European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


Refractory T Acute Lymphoblastic Leukemia


Somatrogon (genetical recombination) (JAN)

United States
European Union
Japan
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Ustekinumab Biosimilar (Fresenius Kabi USA, Inc.)

United States
European Union
Canada
Iceland
Liechtenstein
Norway


Treatment related acute myeloid leukaemia

Acute Myeloid Leukemia with Myelodysplasia-Related Changes

Acute myeloid leukaemia with 11q23 abnormality

Acute Myeloid Leukemia with FLT3/ITD Mutation

Anemia, Refractory, With Excess of Blasts

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

refractory acute lymphoid leukemia in relapse

Refractory Adult Acute Lymphoblastic Leukemia


Follitropin Alfa  Biosimilar (Alphamab Jilin Co., Ltd.)


Blast Phase Chronic Granulocytic Leukemia

Chronic lymphocytic leukaemia refractory

Steroid Refractory Graft Versus Host Disease


Metastatic castration-resistant prostate cancer

Metastatic Castration-Sensitive Prostate Carcinoma

Prostate Adenocarcinoma with Neuroendocrine Differentiation

United States
China
European Union
Japan
Canada
Australia
Argentina
Brazil
Iceland
South Korea
Liechtenstein
Norway


Efgartigimod Alfa (Genetical Recombination)

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Chronic idiopathic thrombocytopenic purpura

Postural Orthostatic Tachycardia Syndrome

United States
China
European Union
Japan
United Kingdom
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Recombinant Human Follicle Stimulating Hormone (Jingze Biotech)

Follicle stimulating hormone Biosimilar (Shanghai Jingze Biotechnology Co., Ltd.)


Metastatic Triple-Negative Breast Carcinoma

T-cell Acute Lymphoblastic Leukemia/Lymphoma

Colorectal Cancer, Hereditary Nonpolyposis, Type 1

Primary Cutaneous Anaplastic Large Cell Lymphoma


United States
European Union
Japan
Iceland
Liechtenstein
Norway


Trastuzumab Biosimilar (Prestige BioPharma)

Trastuzumab biosimilar (Hanwha Biologics)

HER2 positive Gastroesophageal Junction Adenocarcinoma

Metastatic human epidermal growth factor 2 positive carcinoma of breast

European Union
Iceland
Liechtenstein
Norway


Voltage-gated calcium channel alpha2/delta subunit 1


United States
China
European Union
Japan
Iceland
Liechtenstein
Norway


Phosphatidylinositol-4,5-Bisphosphate 3 kinase gamma

Advanced Head and Neck Squamous Cell Carcinoma

Recurrent Squamous Cell Carcinoma of the Head and Neck

Primary cutaneous CD8 positive aggressive epidermotropic cytotoxic T-cell lymphoma

Recurrent Nodal Peripheral T-Cell Lymphoma with TFH Phenotype

Subcutaneous Panniculitis-Like T-Cell Lymphoma

Diffuse large B-cell lymphoma refractory

Chronic lymphocytic leukaemia refractory

Locally Advanced Malignant Solid Neoplasm

Recurrent Childhood Acute Lymphoblastic Leukemia

Refractory Indolent Non-Hodgkin Lymphoma

Squamous cell carcinoma of head and neck metastatic


calcium voltage-gated channel subunit alpha1 C

Voltage-gated N-type calcium channel alpha-1B subunit


Microsatellite instability-high colorectal cancer

Squamous Cell Carcinoma of Head and Neck

PD-L1 positive Non-Small Cell Lung Cancer


Sleep Initiation and Maintenance Disorders

Obstructive Sleep Apnea Hypopnea Syndrome


(R)-(+)-1-(α-methylbenzyl)imidazole-5-carboxylic acid ethyl ester

(R)-1-(1-phenylethyl)-1H-imidazole-5-carboxylic acid ethyl ester

3-((R)-1-Phenyl-ethyl)-3H-imidazole-4-carboxylic acid ethyl ester


Heart failure with normal ejection fraction

Metabolic dysfunction-associated steatotic liver disease

Metabolic Dysfunction Associated Steatohepatitis

Reduced ejection fraction co-occurrent and due to chronic heart failure

United States
China
European Union
Japan
United Kingdom
Canada
Australia
India
Iceland
South Korea
Liechtenstein
Norway
South Africa


Carbapenem Resistant Bacterial Infection


Hyaluronidase (human recombinant) (USAN)

Vorhyaluronidase Alfa (genetical recombination) (JAN)


Recombinant COVID-19 Vaccine for nasal use (CanSino Biotech)

Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation


Recombinant novel coronavirus 2-valent (Alpha + Beta variants) S trimeric protein vaccine

Bivalent recombinant trimeric Sprotein vaccine Sinocelltech

Recombinant protein
Prophylactic vaccine


Antihemophilic Factor (Recombinant), Porcine Sequence

Antihemophilic factor (recombinant) porcine sequence

Antihemophilic factor porcine, B-domain truncated recombinant

Porcine recombinant factor VIII B-domain truncated


Collagenase clostridium histolyticum (LiaoNing Weibang)


Hepatitis C virus NS5B RNA-dependent RNA polymerase

United States
China
European Union
Japan
Canada
Australia
Switzerland
Iceland
South Korea
Liechtenstein
Norway


FINLAY-FR2 anti-SARS-CoV-2 Vaccine(Finlay Vaccine Institute)


Mitochondrial permeability transition pore

Ophthalmoplegia, Chronic Progressive External


Insulin degludec/Insulin aspart (Huisheng Pharm)

Insulin Degludec / Insulin Aspart Biosimilar (Jilin Huisheng Biological Pharmaceutical Co., Ltd.)

德谷门冬双胰岛素生物类似药（Jilin Huisheng Biological Pharmaceutical Co., Ltd.）