United States
United Kingdom
Canada
Australia
Belgium
Bulgaria
Cyprus
Czechia
Germany
Denmark
Estonia
Spain
Finland
France
Greece
Croatia
Hungary
Ireland
Iceland
Italy
South Korea
Lithuania
Luxembourg
Latvia
Malta
Netherlands
Norway
Poland
Portugal
Romania
Sweden
Slovakia


Dementia due to Alzheimer's disease (disorder)

Frontotemporal Dementia With Motor Neuron Disease

Small molecule drug
Diagnostic radiopharmaceuticals

United States
European Union
Japan
United Kingdom
Iceland
Liechtenstein
Norway


Botulinum toxin type A(Lanzhou Institute of Biological Products)


Peroxisome proliferator-activated receptor α


Type 2 diabetes mellitus with established diabetic nephropathy

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


COMIRNATY  Original/Omicron BA.1 15/15 µg

COVID-19 mRNA Vaccine (nucleoside modified)

Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)

Omicron BA.1-Adapted Bivalent COVID-19 Vaccine Booster

P2-mutated full spike protein modRNA prime/boost vaccine (COVID-19),

United States
European Union
Japan
United Kingdom
Canada
Australia
Bahrain
Switzerland
Hong Kong
Israel
Iceland
South Korea
Liechtenstein
Mexico
Norway
Saudi Arabia


Protein kinase AMP-activated non-catalytic subunit beta 1


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


Secondary malignant neoplasm of peritoneum


Imipenem Monohydrate/Cilastatin Sodium/Relebactam Monohydrate

Relebactam Hydrate/Imipenem Hydrate/Cilastatin Sodium

Ventilator associated bacterial pneumonia

Carbapenem Resistant Bacterial Infection

United States
China
European Union
Japan
Canada
Iceland
Liechtenstein
Norway


Metastatic castration-resistant prostate cancer

Childhood Central Nervous System Neoplasm

Large cell neuroendocrine carcinoma of lung

United States
China
Japan
United Kingdom
Canada
Australia
South Korea


Chemotherapy-induced nausea and vomiting


Multiple Sclerosis, Secondary Progressive


China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Nanocomplexes of doxorubicin and DNA fragments (University of California, Irvine)

Urothelial Carcinoma of the Urinary Bladder

Epstein-Barr virus associated Diffuse Large B-Cell Lymphoma

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

T-cell/histiocyte rich large B-cell lymphoma

CD20 positive Diffuse Large B-Cell Lymphoma

GRPR Positive/ER Positive/HER2 Negative Breast Cancer

Hormone receptor positive HER2 positive breast cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Muscle Invasive Bladder Urothelial Carcinoma

Nodular Sclerosis Classical Hodgkin Lymphoma

Precursor B-lymphoblastic lymphoma/leukemia refractory

Recurrent B Acute Lymphoblastic Leukemia

Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Refractory B Acute Lymphoblastic Leukemia


Trastuzumab Biosimilar (Celltrion, Inc.)

HER2 positive Gastroesophageal Junction Adenocarcinoma

Metastatic HER2 positive gastroesophageal junction cancer

Advanced Gastroesophageal Junction Adenocarcinoma

United States
European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


PD-L1 positive Triple Negative Breast Cancer

Metastatic Gastroesophageal Junction Adenocarcinoma

Platinum-Resistant Epithelial Ovarian Carcinoma

Platinum-Resistant Fallopian Tube Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma

HER2 positive Gastrooesophageal junction cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Locally Advanced Unresectable Breast Carcinoma

Metastatic Carcinoma to the Uterine Cervix

HER2-expressing Gastroesophageal Junction Adenocarcinoma


Hyperpolarization-activated cyclic nucleotide-gated channel

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

Postural Orthostatic Tachycardia Syndrome


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


Abilify Prolonged Release Aqueous Suspension

Dementia due to Alzheimer's disease (disorder)

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


Peroxisome proliferator-activated receptor α

Peroxisome proliferator-activated receptor delta

Metabolic Dysfunction Associated Steatohepatitis

Metabolic dysfunction-associated steatotic liver disease

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


China
European Union
Japan
Canada
Iceland
Liechtenstein
Norway


Platinum-Resistant Epithelial Ovarian Carcinoma

Platinum-Resistant Fallopian Tube Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma


Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

HER2-positive Non-squamous non-small cell lung cancer

Resectable Lung Non-Small Cell Carcinoma

Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma

HER2 Positive Adenocarcinoma of Esophagus

HER2 positive Gastrooesophageal junction cancer

Metastatic Gastroesophageal Junction Adenocarcinoma

Metastatic human epidermal growth factor 2 positive carcinoma of breast


United States
European Union
Japan
Canada
Switzerland
Iceland
Liechtenstein
Norway


Polyarticular Juvenile Idiopathic Arthritis

Juvenile Pauciarticular Chronic Arthritis

Systemic onset juvenile chronic arthritis

United States
China
European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


Ropivacaine Hydrochloride and Sodium Chloride

Sodium voltage-gated channel alpha subunits

United States
China
Japan
United Kingdom
Canada
Australia
Austria
Belgium
Germany
France
Ireland
Italy
Luxembourg
Netherlands


Deficiency of Interleukin-1 Receptor Antagonist

Familial Cold Autoinflammatory Syndrome 2


Insulin Glargine Biosimilar (Dongyangguang)


cytochrome P450 family 2 subfamily C member 19

cytochrome P450 family 2 subfamily C member 8

Multidrug resistant pulmonary tuberculosis

United States
China
European Union
India
Hong Kong
Iceland
South Korea
Liechtenstein
Norway


Multiple Sclerosis, Secondary Progressive


Diagnostic radiopharmaceuticals
Radionuclide Drug Conjugates (RDC)


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


Dupilumab (genetical recombination) (JAN)

Chronic rhinosinusitis with nasal polyps

Chronic rhinosinusitis without nasal polyps

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


China Japan Austria Germany Spain France Greece Hungary Netherlands Portugal


Tetanus human immunoglobulin(China Resources Boya)


Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies


China
European Union
Japan
Canada
Australia
India
Iceland
South Korea
Liechtenstein
Malaysia
Norway
Thailand
Taiwan Province


Type 1 diabetes mellitus with established diabetic nephropathy

United States
European Union
Australia
Switzerland
Iceland
Liechtenstein
Norway


Insulin Glargine(Liaoning Bo'ao Bio-pharma)


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


Recombinant COVID-19 vaccine(CHO cell)(National Vaccine & Serum Institute)

Recombinant protein
Prophylactic vaccine


United States
China
United Kingdom
Canada
Australia
Argentina
Brazil
Denmark
Spain
Ireland
Italy
Philippines


HMN (Hereditary Motor Neuropathy) Proximal Type I

European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


United States
China
European Union
Iceland
Liechtenstein
Norway


Complicated skin and skin structure infection

Non-complicated skin and skin structure infection

Skin structures and soft tissue infections


China
European Union
Japan
Iceland
Liechtenstein
Norway


Anti-interleukin 17A monoclonal antibody

Metabolic dysfunction-associated steatotic liver disease


Transthyretin-related (ATTR) familial amyloid polyneuropathy

United States
China
European Union
United Kingdom
Canada
Iceland
Liechtenstein
Norway


Chemotherapy-induced nausea and vomiting


Protein kinase AMP-activated non-catalytic subunit beta 1


Juvenile Pauciarticular Chronic Arthritis

Systemic onset juvenile chronic arthritis

United States
China
European Union
Japan
Iceland
Liechtenstein
Norway


Meclizine Hydrochloride Hydrate/Chlorpheniramine Maleate/Pyridoxine Hydrochloride/Anhydrous Caffeine


Tegafur Gimeracil Oteracil Potassium Capsule

Tegafur, Gimeracil and Oteracil Potassium

Hormone receptor positive HER2 positive breast cancer

Hormone receptor positive HER2 negative breast cancer

Locally Advanced Pancreatic Adenocarcinoma

Locally Advanced Unresectable Gastric Adenocarcinoma

Malignant neoplasm of gastro-oesophageal junction


3-phosphoinositide-dependent protein kinase 1

BRAF fusion or rearrangement postive low-grade glioma

BRAF V600E mutation-positive low grade glioma

Refractory Langerhans Cell Histiocytosis

Locally Advanced Malignant Solid Neoplasm

Urothelial Carcinoma of the Urinary Bladder


Signal transducer and activator of transcription 3


コロナウイルス（SARS-CoV-2）ワクチン（遺伝子組換えアデノウイルスベクター）(Janssen)

COVID-19 vaccine (Ad26.COV2-S [recombinant])

SARS-CoV-2 recombinant adenoviral vector vaccine

Recombinant vector vaccine
Prophylactic vaccine


Attention Deficit Disorder With Hyperactivity

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


United States
European Union
United Arab Emirates
Iceland
Liechtenstein
Norway


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


Immunoglobulin G1 (mouse monoclonal IMMU-MN3 Fab' fragment gamma-chain anti-human NCA-90 granulocyte cell antigen), disulfide with mouse monoclonal IMMU-MN3 light chain

Carcinoembryonic antigen related cell adhesion molecule 6

Radiolabeled antibody
Diagnostic radiopharmaceuticals


Metastatic Castration-Sensitive Prostate Carcinoma

Metastatic castration-resistant prostate cancer


Extramedullary Disease in Multiple Myeloma

CD20 positive Diffuse Large B-Cell Lymphoma

Acute myeloid leukaemia with 11q23 abnormality

Acute myeloid leukemia with multilineage dysplasia

Adult acute myeloid leukemia with del(5q)

Anemia, Refractory, With Excess of Blasts

CD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma

Diffuse large B-cell lymphoma refractory

EBV-Related Post-Transplant Lymphoproliferative Disorder

Locally Advanced Lung Non-Small Cell Carcinoma

Metastatic Carcinoma to the Uterine Cervix

Metastatic Clear Cell Renal Cell Carcinoma

Noninsulin-Dependent Diabetes Mellitus With Deafness

Platinum-Resistant Primary Peritoneal Carcinoma

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Childhood Acute Lymphoblastic Leukemia

Recurrent Platinum-Resistant Ovarian Carcinoma

Steroid Refractory Graft Versus Host Disease

United States
European Union
Japan
Canada
Australia
Brazil
Iceland
Liechtenstein
Norway


Lyophilized human C1-inactivator concentrate

United States
Japan
Canada
Australia
Germany
South Korea


Trastuzumab (genetical recombination) (JAN)

HER2 positive Gastroesophageal Junction Adenocarcinoma

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Estrogen receptor positive breast cancer

Hormone receptor positive HER2 positive breast cancer

HER2 Positive Gastroesophageal Adenocarcinoma

Metastatic HER2 positive gastroesophageal junction cancer

Metastatic Malignant Neoplasm to the Leptomeninges

HER2 positive Gastrooesophageal junction cancer

Human epidermal growth factor 2 negative carcinoma of breast

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Locally Advanced Malignant Solid Neoplasm

progesterone receptor-negative breast cancer

Recurrent HER2-Negative Breast Carcinoma

Squamous cell carcinoma of head and neck metastatic

Urothelial Carcinoma of the Urinary Bladder


Mixed Protamine Human Insulin Injection (30R)


Bevacizumab Biosimilar (mAbxience Research SL)

Metastatic Carcinoma to the Uterine Cervix

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Platinum-sensitive epithelial ovarian cancer

Platinum-Sensitive Primary Peritoneal Carcinoma

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

United States
European Union
Brazil
Iceland
Liechtenstein
Norway


United States
European Union
Japan
United Kingdom
Australia
Iceland
Liechtenstein
Norway


Metastatic Triple-Negative Breast Carcinoma


Intermediate Atypical Prostate Carcinoma

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


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

HR Positive/HER2 Negative/Node positive breast cancer

PIK3CA mutated/HER2 Positive Breast Cancer

Advanced Triple-Negative Breast Carcinoma

Hormone receptor positive HER2 negative breast cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Megalencephaly Cutis Marmorata Telangiectatica Congenita

Hormone Receptor Positive Breast Adenocarcinoma

Recurrent Squamous Cell Carcinoma of the Head and Neck

Squamous cell carcinoma of head and neck metastatic

Estrogen receptor positive breast cancer

HPV positive oropharyngeal squamous cell carcinoma

Human Papillomavirus-Related Squamous Cell Carcinoma of the Penis

Locally Advanced Head and Neck Squamous Cell Carcinoma

Locally Advanced Malignant Solid Neoplasm

Metastatic HER2-Negative Breast Carcinoma

Recurrent Triple-Negative Breast Carcinoma

Well Differentiated Pancreatic Endocrine Tumor

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


Fc fusion protein
Colony-stimulating factors

United States
China
European Union
Iceland
Liechtenstein
Norway
Thailand


Anti-BCMA CART Cell Therapy - bluebird bio/Celgene

Anti-BCMA CART cells - bluebird bio/Celgene

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


Ustekinumab (BIOSIMILAR COLLABORATIONS IRELAND LIMITED)

United States
European Union
Japan
Canada
Iceland
Liechtenstein
Norway


COVID-19 S-Trimer vaccine (Sichuan Clover Biopharmaceuticals, Inc)

Prophylactic vaccine
Genetically engineered subunit vaccine


COVID-19 mRNA vaccine (CSPC Pharmaceutical)

COVID-19 mRNA Vaccine(containing BA.5 key mutations)  (CSPC Pharmaceutical)


European Union
Iceland
Liechtenstein
Norway


Neuronal acetylcholine receptor; alpha4/beta2

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


Denosumab Biosimilar (Suzhou Alphamab Co., Ltd.)

Recombinant human anti-RANKL antibody(Suzhou Alphamab)

Tumor necrosis factor ligand superfamily member 11


DnaJ heat shock protein family (Hsp40) member B3


KRAS G12C mutant Non-small Cell Lung Cancer

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

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


Y-shape pegylated somatropin (Xiamen Amoytop Biotech)

Somatropin Biosimilar (Xiamen Amoytop Biotech Co. Ltd.)

YPEG-rhGH(Xiamen Amoytop Biotech Co. Ltd.)


Locally Advanced Lung Non-Small Cell Carcinoma

Locally Advanced Pancreatic Adenocarcinoma

Urothelial Carcinoma of the Urinary Bladder

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Non-Muscle Invasive Bladder Urothelial Carcinoma

Diffuse midline glioma, point mutation K27M in histone H3

Advanced Head and Neck Squamous Cell Carcinoma

Advanced Lung Non-Small Cell Squamous Carcinoma

Advanced Pancreatic Ductal Adenocarcinoma

Locally Advanced Malignant Solid Neoplasm

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

Metastatic Triple-Negative Breast Carcinoma

Platinum-Resistant Fallopian Tube Carcinoma

Platinum-Sensitive Primary Peritoneal Carcinoma

Recurrent HER2-Negative Breast Carcinoma

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

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

Recurrent Platinum-Resistant Primary Peritoneal Carcinoma

Renal Pelvis and Ureter Urothelial Carcinoma

Resectable Lung Non-Small Cell Carcinoma

Squamous Cell Carcinoma of Head and Neck

Transitional cell cancer of renal pelvis and ureter metastatic

Transitional cell cancer of the renal pelvis and ureter recurrent

Unresectable Lung Non-Small Cell Carcinoma

United States
China
Japan
Australia
Brazil


Insulin Human (rDNA)(Baxter Holding B.V.)

insulin human (rDNA)(Baxter Holding B.V.)


United States
China
Japan
Germany
Sweden


United States
China
European Union
Australia
Iceland
Liechtenstein
Norway


Peroxisome proliferator-activated receptor γ

Chemotherapy-induced nausea and vomiting


Recombinant human parathyroid hormone(Shenzhen Salubris Pharmaceuticals Co., Ltd.)

Teriparatide biosimilar (Shenzhen Salubris )

Recombinant polypeptide
Biosimilar
Peptide Hormone


Extramedullary Disease in Multiple Myeloma

Monoclonal Gammopathy of Undetermined Significance

Urothelial Carcinoma of the Urinary Bladder

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Recurrent B Acute Lymphoblastic Leukemia

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


对乙酰氨基酚/马来酸氯苯那敏/无水咖啡因/盐酸伪麻黄碱/氢溴酸右美沙芬水合物/盐酸DL-甲基麻黄碱/核黄素/抗坏血酸

Acetaminophen/Chlorpheniramine Maleate/Anhydrous Caffeine/Pseudoephedrine Hydrochloride/Dextromethorphan Hydrobromide Hydrate/DL-Methylephedrine Hydrochloride/Riboflavin/Ascorbic Acid


Aromatic Amino Acid Decarboxylase Deficiency

United States
European Union
United Kingdom
Iceland
Liechtenstein
Norway


Dementia due to Alzheimer's disease (disorder)


エルビテグラビル/コビシスタット/エムトリシタビン/テノホビル ジソプロキシルフマル酸塩

United States
European Union
Japan
Iceland
Liechtenstein
Norway


Tocilizumab Biosimilar (Fresenius Kabi Deutschland GmbH)

托珠单抗生物类似药（Fresenius Kabi Deutschland GmbH）

Polyarticular Juvenile Idiopathic Arthritis

Systemic onset juvenile chronic arthritis

United States
European Union
Canada
Iceland
Liechtenstein
Norway


Hormone receptor positive HER2 negative breast cancer

HR Positive/HER2 Negative/Node positive breast cancer

Locally Advanced Lung Non-Small Cell Carcinoma


Chimeric anti-interleukin-6 monoclonal antibody

Metastatic castration-resistant prostate cancer

Monoclonal Gammopathy of Undetermined Significance

United States
China
European Union
Australia
Iceland
South Korea
Liechtenstein
Norway


Type 2 diabetes mellitus with established diabetic nephropathy


Tremelimumab (genetical recombination) (JAN)

Cytotoxic T-Lymphocyte-Associated Antigen 4

Locally Advanced Hepatocellular Carcinoma

Metastatic Clear Cell Renal Cell Carcinoma

Locally Advanced Unresectable Gastric Adenocarcinoma

EGFR positive non-small cell lung cancer

HPV positive oropharyngeal squamous cell carcinoma

Recurrent Platinum-Resistant Primary Peritoneal Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Urothelial Carcinoma of the Urinary Bladder

Malignant neoplasm of gastro-oesophageal junction

Squamous cell carcinoma of the oral cavity

Squamous Cell Carcinoma of Head and Neck

Non-Muscle Invasive Bladder Urothelial Carcinoma

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Locally Advanced Head and Neck Squamous Cell Carcinoma

Diffuse large B-cell lymphoma refractory

Human Papillomavirus-Related Oropharyngeal Neoplasms

Locally Advanced Lung Non-Small Cell Carcinoma

Locally Advanced Malignant Solid Neoplasm

Metastatic Carcinoma to the Uterine Cervix

Metastatic Gastroesophageal Junction Adenocarcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

Recurrent Squamous Cell Carcinoma of the Head and Neck

Resectable Lung Non-Small Cell Carcinoma

Small cell neuroendocrine carcinoma of bladder

Squamous cell carcinoma of head and neck metastatic

Transitional cell cancer of renal pelvis and ureter metastatic

Unresectable Pleural Malignant Mesothelioma


N-[[4-[(2-aminoanilino)-oxomethyl]phenyl]methyl]carbamic acid 3-pyridinylmethyl ester

Hormone receptor positive HER2 negative breast cancer

HR Positive/HER2 Negative/Node positive breast cancer

Advanced Triple-Negative Breast Carcinoma

Estrogen receptor positive breast cancer

Estrogen receptor-negative breast cancer

Fallopian Tube Clear Cell Adenocarcinoma

Fallopian Tube High Grade Serous Adenocarcinoma

high grade serous adenocarcinoma of ovary

Metastatic castration-resistant prostate cancer

Microsatellite instability-high colorectal cancer

Platinum-Resistant Fallopian Tube Carcinoma

Primary Peritoneal Serous Adenocarcinoma

progesterone receptor-negative breast cancer

Recurrent Platinum-Resistant Primary Peritoneal Carcinoma


Tocilizumab biosimilar (Bio-Thera Solutions)

Polyarticular Juvenile Idiopathic Arthritis

Systemic onset juvenile chronic arthritis

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


DL-Methylephedrine Hydrochloride/Guaifenesin/Noscapine Hydrochloride Hydrate/Acetaminophen


United States
China
Japan
Australia
Switzerland
Germany
Finland
Italy
South Korea


G-protein coupled receptor family C group 5member D

Extramedullary Disease in Multiple Myeloma


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


Viekira Pak (ombitasvir/paritaprevir/ritonavir combination therapy)

Human immunodeficiency virus type 1 Pol protein

Hepatitis C virus serine protease, NS3/NS4A


United States
United Kingdom
Switzerland


重组新冠病毒Beta/Omicron(BA.1/BQ.1.1/XBB.1)变异株S三聚体蛋白疫苗 (神州细胞)

Recombinant novel coronavirus Beta/Omicron (BA.1/BQ.1.1/XBB.1) S trimeric protein vaccine (Sinocelltech)

重组新冠病毒Beta/Omicron(BA.1/BQ.1.1/XBB.1)变异株S三聚体蛋白疫苗(神州细胞)


Mixed Protamine Zine Recombinant Human Insulin Lispro (Wanbang Biopharma)


CLDN18.2 positive  Gastroesophageal junction adenocarcinoma

CLDN18.2 positive  stomach adenocarcinoma

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Metastatic Gastroesophageal Junction Adenocarcinoma

CLDN18.2 positive  Pancreatic adenocarcinoma

CLDN18.2 Positive Gastrointestinal Neoplasms

Malignant neoplasm of gastro-oesophageal junction

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


Tumor-associated calcium signal transducer 2

Metastatic Triple-Negative Breast Carcinoma

Hormone receptor positive HER2 negative breast cancer

HR Positive/HER2 Negative Lobular Carcinoma

Locally Advanced Unresectable Breast Carcinoma

Hormone receptor negative HER2 positive breast cancer

HPV positive oropharyngeal squamous cell carcinoma

Squamous Cell Carcinoma of Head and Neck

Squamous cell carcinoma of the hypopharynx

Squamous cell carcinoma of the oral cavity

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Urothelial Carcinoma of the Urinary Bladder

Advanced Esophageal Squamous Cell Carcinoma

Platinum-Resistant Fallopian Tube Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Non-Muscle Invasive Bladder Urothelial Carcinoma

Resectable Lung Non-Small Cell Carcinoma

Locally Advanced Malignant Solid Neoplasm

Metastatic HER2-Negative Breast Carcinoma

PD-L1 negative Triple Negative Breast Cancer

progesterone receptor-negative breast cancer

Metastatic castration-resistant prostate cancer

Advanced Triple-Negative Breast Carcinoma

Renal Pelvis and Ureter Urothelial Carcinoma

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


Belimumab (genetical recombination) (JAN)

B-cell-activating factor/B lymphocyte stimulator

Interstitial lung disease due to connective tissue disease

Interstitial lung disease due to systemic disease

Chronic lymphocytic leukaemia refractory

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Nuclear factor erythroid 2-related factor 2


Dementia due to Alzheimer's disease (disorder)

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


United States
European Union
Canada
Australia
Switzerland
Iceland
Liechtenstein
Norway


United States
European Union
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Human Coagulation Factor IX (Yuanda Shuyang)


Attention Deficit Disorder With Hyperactivity


Fluticasone Propionate/Formoterol Fumarate Hydrate


BRCA Mutation Castration-Resistant Prostate Cancer

HRR Gene-mutated Castration-Resistant Prostate Cancer

Germline BRCA-mutated, HER2-negative metastatic breast cancer

Metastatic Castration-Sensitive Prostate Carcinoma

Urothelial Carcinoma of the Urinary Bladder

Colorectal Cancer, Hereditary Nonpolyposis, Type 1

Metastatic Gastroesophageal Junction Adenocarcinoma

Anemia, Refractory, With Excess of Blasts

Advanced Triple-Negative Breast Carcinoma

Human epidermal growth factor 2 negative carcinoma of breast

Locally Advanced Head and Neck Squamous Cell Carcinoma

Locally Advanced Malignant Solid Neoplasm

Metastatic Clear Cell Renal Cell Carcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

Metastatic Triple-Negative Breast Carcinoma

Recurrent HER2-Negative Breast Carcinoma

Squamous Cell Carcinoma of Head and Neck

Squamous cell carcinoma of head and neck metastatic


Advanced Lung Non-Squamous Non-Small Cell Carcinoma

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

Unresectable Pleural Malignant Mesothelioma

Recurrent Squamous Cell Carcinoma of the Head and Neck

Human Papillomavirus-Related Head and Neck Neoplasms

Squamous Cell Carcinoma of the Oropharynx

Hormone receptor negative HER2 positive breast cancer

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Advanced Triple-Negative Breast Carcinoma

Locally Advanced Head and Neck Squamous Cell Carcinoma

Metastatic castration-resistant prostate cancer

Primary Peritoneal High-Grade Serous Adenocarcinoma

Advanced Lung Non-Small Cell Squamous Carcinoma

EGFR positive Non-squamous non-small cell lung cancer

Hormone Receptor Positive Breast Adenocarcinoma

HPV positive oropharyngeal squamous cell carcinoma

Human Papillomavirus-Related Squamous Cell Carcinoma of the Penis

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Locally Advanced Malignant Solid Neoplasm

Malignant neoplasm of gastro-oesophageal junction

Metastatic Carcinoma to the Uterine Cervix

Metastatic Gastroesophageal Junction Adenocarcinoma

Metastatic Triple-Negative Breast Carcinoma

Platinum-Resistant Epithelial Ovarian Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma

Platinum-Sensitive Primary Peritoneal Carcinoma

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

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

Resectable Lung Non-Small Cell Carcinoma

Squamous cell carcinoma of the hypopharynx

Squamous cell carcinoma of the oral cavity

T-cell/histiocyte rich large B-cell lymphoma

Transitional cell cancer of the renal pelvis and ureter recurrent

Unresectable Lung Non-Small Cell Carcinoma


Multiple Sclerosis, Secondary Progressive


Chronic idiopathic thrombocytopenic purpura

Steroid Refractory Graft Versus Host Disease

Recurrent Platinum-Resistant Ovarian Carcinoma

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


Pertuzumab biosimilar (Qilu Pharmaceutical)

Pertuzumab Biosimilar (Qilu Pharmaceutical Co., Ltd.)


Type 2 diabetes mellitus with established diabetic nephropathy

Heart failure with normal ejection fraction


Sodium Sulfamethoxazole/Aminocaproic Acid/Glycyrrhizinate dipotassium/Chlorphenamine Maleate

Corticosteroid 11-beta-dehydrogenase isozyme 1


Liraglutide biosimilar (Zhongmei Huadong)


Metabolic dysfunction-associated steatotic liver disease

EGFR positive non-small cell lung cancer

Non ST segment elevation acute coronary syndrome

United States
China
Japan
Australia
Austria
Belgium
Brazil
Germany
Denmark
Spain
Finland
France
Greece
Ireland
Italy
Luxembourg
Netherlands
Norway
Poland
Portugal
Sweden


Trastuzumab Emtansine (Genetical Recombination)

Metastatic human epidermal growth factor 2 positive carcinoma of breast

progesterone receptor-negative breast cancer


Metabolic Dysfunction Associated Steatohepatitis


Cysteamine bitartrate - Chiesi Farmaceutici/Horizon Therapeutics plc

Cysteamine bitartrate controlled release - Chiesi Farmaceutici/Horizon Therapeutics plc

United States
European Union
Japan
Canada
Iceland
Liechtenstein
Norway


Corticotropin-releasing factor receptor 1

Congenital Adrenal Hyperplasia Due to 21 Hydroxylase Deficiency


United States
China
Japan
United Kingdom
Canada
Australia
Austria
Belgium
Bulgaria
Cyprus
Czechia
Germany
Denmark
Spain
Finland
France
Greece
Hungary
Ireland
Iceland
Italy
Liechtenstein
Lithuania
Luxembourg
Latvia
Malta
Netherlands
Norway
Portugal
Romania
Sweden
Slovenia
Slovakia


Equine anti-Tetanus F(ab')2(YUXI Jiuzhou)


HMN (Hereditary Motor Neuropathy) Proximal Type I


Metastatic castration-resistant prostate cancer

Hormone receptor negative HER2 positive breast cancer

Metastatic Castration-Sensitive Prostate Carcinoma

Small molecule drug
Therapeutic radiopharmaceuticals

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


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


Metastatic Carcinoma to the Uterine Cervix

Locally Advanced Lung Non-Small Cell Carcinoma

Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck

PD-L1 positive Non-Small Cell Lung Cancer

Urothelial Carcinoma of the Urinary Bladder

Locally Advanced Malignant Solid Neoplasm

Microsatellite Stable Colorectal Carcinoma

Squamous cell carcinoma of the oral cavity recurrent

Resectable Lung Non-Small Cell Carcinoma

Microsatellite instability-high colorectal cancer

Mismatch repair-deficient Colonic Cancer

Human Papillomavirus-Related Head and Neck Neoplasms

Human Papillomavirus-Related Squamous Cell Carcinoma

Squamous Cell Carcinoma of Head and Neck

Metastatic castration-resistant prostate cancer

KRAS-mutated low-grade serous ovarian cancer

Locally Advanced Head and Neck Squamous Cell Carcinoma

HPV positive oropharyngeal squamous cell carcinoma

Human Papillomavirus-Related Oropharyngeal Neoplasms

Recurrent Squamous Cell Carcinoma of the Head and Neck

Refractory Central Nervous System Lymphoma

Squamous cell carcinoma of head and neck metastatic

Squamous cell carcinoma of the hypopharynx

Squamous Cell Carcinoma of the Oropharynx

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


Metastatic Triple-Negative Breast Carcinoma

PD-L1 positive Triple Negative Breast Cancer

Locally Advanced Pancreatic Adenocarcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

Urothelial Carcinoma of the Urinary Bladder

Advanced Triple-Negative Breast Carcinoma

Squamous Cell Carcinoma of Head and Neck

Locally Advanced Unresectable Gastric Adenocarcinoma

Advanced Lung Non-Small Cell Squamous Carcinoma

Advanced Pancreatic Ductal Adenocarcinoma

Estrogen receptor-negative breast cancer

GRPR Positive/ER Positive/HER2 Negative Breast Cancer

Hormone Receptor Positive Breast Adenocarcinoma

Locally Advanced Esophageal Squamous Cell Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Malignant neoplasm of gastro-oesophageal junction

Metastatic castration-resistant prostate cancer

Metastatic Gastroesophageal Junction Adenocarcinoma

Metastatic HER2-Negative Breast Carcinoma

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Metastatic Pancreatic Ductal Adenocarcinoma

Platinum-Sensitive Primary Peritoneal Carcinoma

progesterone receptor-negative breast cancer

Recurrent Platinum-Resistant Primary Peritoneal Carcinoma

Renal Pelvis and Ureter Urothelial Carcinoma

Resectable Lung Non-Small Cell Carcinoma

Transitional cell cancer of the renal pelvis and ureter recurrent

United States
China
European Union
Japan
United Kingdom
Argentina
Dominican Republic
Iceland
Liechtenstein
Macao
Malaysia
Norway
Oman
Peru
Philippines
Uruguay


Methyl Salicylate/L-Menthol/DL-Camphor/Tocopherol Acetate/Vanillyl Nonylamide

Transient receptor potential cation channel subfamily A member 1

Transient receptor potential cation channel subfamily M member 8


United States
Japan
United Kingdom
Australia
Austria
Belgium
Cyprus
Germany
Denmark
Spain
Finland
France
Greece
Hungary
Ireland
Iceland
Italy
Luxembourg
Netherlands
Norway
Poland
Portugal
Sweden
Slovenia
Slovakia


China
Japan
Australia
Germany
South Korea


Divalproex sodium DR 500mg tablets - Abbott Laboratories

Gamma-aminobutyric acid (GABA) receptors


Recombinant human follicle-stimulating hormone-CTP fusion protein (Shengji Pharma)


Acetaminophen/Dextromethorphan Hydrobromide Hydrate/DL-Methylephedrine Hydrochloride/Guaifenesin/Anhydrous Caffeine


Tenofovir disoproxil fumarate (JAN/USAN)


Ecostigmine iodide - Fera Pharmaceuticals


Proto-oncogene tyrosine-protein kinase ROS

ALK-positive anaplastic large cell lymphoma

Locally Advanced Malignant Solid Neoplasm

Reactive oxygen species 1 positive non-small cell lung cancer

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


T-cell/histiocyte rich large B-cell lymphoma

Chronic lymphocytic leukaemia refractory

CD20 positive Diffuse Large B-Cell Lymphoma

Recurrent Central Nervous System Lymphoma

Secondary Central Nervous System Lymphoma

Diffuse large B-cell lymphoma refractory

Extramedullary Disease in Multiple Myeloma

Refractory Central Nervous System Lymphoma

Acute myeloid leukaemia with 11q23 abnormality

Adult acute myeloid leukemia with del(5q)

Anemia, Refractory, With Excess of Blasts

CD20 Positive B-Cell Chronic Lymphocytic Leukemia

CD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma

Monoclonal Gammopathy of Undetermined Significance

Nodular Sclerosis Classical Hodgkin Lymphoma

Non-Muscle Invasive Bladder Urothelial Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Aggressive Non-Hodgkin Lymphoma

Recurrent Childhood Acute Lymphoblastic Leukemia

Recurrent Squamous Cell Carcinoma of the Head and Neck

Refractory Aggressive Non-Hodgkin Lymphoma

Refractory B Acute Lymphoblastic Leukemia

Refractory cytopenia with multilineage dysplasia

Refractory Differentiated Thyroid Gland Carcinoma

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

Refractory High Risk Myelodysplastic Syndrome

Refractory Indolent Non-Hodgkin Lymphoma

Squamous Cell Carcinoma of Head and Neck

Squamous cell carcinoma of head and neck metastatic

Subcutaneous Panniculitis-Like T-Cell Lymphoma

Treatment related acute myeloid leukaemia


Sodium channel protein type X alpha subunit


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


Human immunodeficiency virus type 1 protease


NACHT, LRR and PYD domains-containing protein 3

United States
China
Japan
United Kingdom
Canada
Brazil
Finland
France
Greece
Ireland
Italy
Luxembourg
Portugal
Sweden


Tocilizumab (genetical recombination) (JAN)

Interstitial lung disease due to systemic disease

Polyarticular Juvenile Idiopathic Arthritis

Systemic onset juvenile chronic arthritis

Metastatic Triple-Negative Breast Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Urothelial Carcinoma of the Urinary Bladder

Idiopathic pulmonary arterial hypertension

United States
China
European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


Attention Deficit Disorder With Hyperactivity


Sodium voltage-gated channel alpha subunits


Choriogonadotropin alfa biosimilar(Livzon Pharmaceutical Group, Inc.)


China
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


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


Peroxisome proliferator activated receptor

Metabolic Dysfunction Associated Steatohepatitis


United States
European Union
Japan
Hong Kong
Iceland
Liechtenstein
Macao
Norway
Taiwan Province


Metastatic Esophageal Squamous Cell Carcinoma

Oesophageal squamous cell carcinoma recurrent

Unresectable Esophageal Squamous Cell Carcinoma

Resectable Lung Non-Small Cell Carcinoma

HER2 Positive Transitional Cell Carcinoma

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

Locally Advanced Esophageal Squamous Cell Carcinoma

PD-L1 positive Transitional Cell Carcinoma

Locally Advanced Hepatocellular Carcinoma

Recurrent Triple-Negative Breast Carcinoma

Metastatic malignant neoplasm to nasopharynx

Locally Advanced Head and Neck Squamous Cell Carcinoma

Mismatch repair-deficient Colonic Cancer

Locally Advanced Malignant Solid Neoplasm

EGFR positive non-small cell lung cancer

Locally Advanced Lung Non-Small Cell Carcinoma

Urothelial Carcinoma of the Urinary Bladder

Microsatellite Stable Colorectal Carcinoma

Recurrent Squamous Cell Carcinoma of the Head and Neck

Squamous Cell Carcinoma of Head and Neck

Squamous cell carcinoma of head and neck metastatic

Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Metastatic Clear Cell Renal Cell Carcinoma

Metastatic Gastroesophageal Junction Adenocarcinoma

Microsatellite instability-high colorectal cancer

Recurrent Gastroesophageal Junction Adenocarcinoma

United States
China
European Union
United Kingdom
Canada
Australia
India
United Arab Emirates
Bahrain
Hong Kong
Iceland
Jordan
Kuwait
Liechtenstein
Norway
Pakistan
Singapore


European Union
Japan
Iceland
South Korea
Liechtenstein
Norway


Sexual function and fertility disorders NEC


Type 2 diabetes mellitus with established diabetic nephropathy


Blast Phase Chronic Granulocytic Leukemia

Aggressive-Phase Chronic Myelocytic Leukemia

Philadelphia positive acute lymphocytic leukaemia

Recurrent Childhood Acute Lymphoblastic Leukemia

Refractory Adult Acute Lymphoblastic 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)

Anemia, Refractory, With Excess of Blasts

Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia

Philadelphia chromosome positive chronic myelogenous leukemia

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Aggressive Non-Hodgkin Lymphoma

refractory acute lymphoid leukemia in relapse


Indacaterol Acetate/Glycopyrronium Bromide/ Mometasone Furoate

インダカテロール酢酸塩/グリコピロニウム臭化物/モメタゾンフランカルボン酸エステル

China
European Union
Japan
Canada
Iceland
Liechtenstein
Norway


Recombinant human platelet-derived growth factor-beta

Platelet-derived growth factor receptor beta


Metformin Hydrochloride/Dapagliflozin Propanediol Hydrate/Sitagliptin Hydrochloride Hydrate

Protein kinase AMP-activated non-catalytic subunit beta 1


C1 Esterase Inhibitor Subcutaneous (Human)


Transient receptor potential cation channel subfamily V member 1

United States
China
European Union
Iceland
Liechtenstein
Norway


Metabolic Dysfunction Associated Steatohepatitis


Human Prothrombin Complex (Guangdong Wellen Biological Pharmaceutical)


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-small cell lung cancer

Locally Advanced Lung Non-Small Cell Carcinoma


China
United Kingdom
Canada
Australia
Belgium
Spain
France
Greece
Ireland
Italy
Portugal


Diffuse large B-cell lymphoma refractory

Primary mediastinal large B-cell lymphoma recurrent

Metastatic Triple-Negative Breast Carcinoma

Hormone Receptor Positive Breast Adenocarcinoma

Hormone receptor positive HER2 negative breast cancer

high grade serous adenocarcinoma of ovary

Primary Peritoneal High-Grade Serous Adenocarcinoma

Recurrent High Grade Fallopian Tube Serous Adenocarcinoma

Recurrent Transformed B-Cell Non-Hodgkin Lymphoma

Hormone receptor negative HER2 positive breast cancer

Hormone receptor positive HER2 positive breast cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Platinum-Resistant Fallopian Tube Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

Recurrent Platinum-Resistant Primary Peritoneal Carcinoma

Recurrent Primary Peritoneal Endometrioid Adenocarcinoma

Refractory Indolent Non-Hodgkin Lymphoma

Squamous Cell Carcinoma of Head and Neck

T-cell/histiocyte rich large B-cell lymphoma


Hepatitis C virus serine protease, NS3/NS4A


United States
European Union
Canada
Australia
Iceland
Liechtenstein
Norway


United States
China
European Union
Canada
Iceland
Liechtenstein
Norway


European Union
Iceland
Liechtenstein
Norway


Salbutamol Sulfate Sustained -release Tablets


Omalizumab Biosimilar (Synermore Biologics (Suzhou) Co., Ltd.)

Recombinant anti-IgE monoclonal antibody(CSPC Baike (Yantai) Biopharmaceutical Co. Ltd.)

奥马珠单抗生物类似药（Synermore Biologics (Suzhou) Co., Ltd.）

Chronic rhinosinusitis with nasal polyps


United States
China
Japan
Australia
Austria
Belgium
Bulgaria
Brazil
Cyprus
Czechia
Germany
Denmark
Estonia
Spain
Finland
France
Greece
Croatia
Hungary
Ireland
Iceland
Italy
Lithuania
Luxembourg
Latvia
Malta
Netherlands
Norway
Poland
Portugal
Romania
Sweden
Slovakia


Anti-RANKL monoclonal antibody (Boan Biological)

Denosumab Biosimilar (Shandong Boan Biotechnology Co., Ltd.)

Tumor necrosis factor ligand superfamily member 11


Peripheral T-cell lymphoma unspecified recurrent

Peripheral T-cell lymphoma unspecified refractory

ALK-positive anaplastic large cell lymphoma

CD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma

Malignant neoplasm of gastro-oesophageal junction

Primary Cutaneous Anaplastic Large Cell Lymphoma

Refractory Aggressive Non-Hodgkin Lymphoma

Squamous cell carcinoma of head and neck metastatic

Urothelial Carcinoma of the Urinary Bladder

United States
China
Japan
Canada
Australia
South Korea


阿柏西普生物类似药(SAM CHUN DANG PHARM Co., Ltd.)

Aflibercept biosimilar(SAM CHUN DANG PHARM Co., Ltd.)

Aflibercept Biosimilar (SAM CHUN DANG PHARM Co., Ltd.)

阿柏西普生物类似药（SAM CHUN DANG PHARM Co., Ltd.）

Retinal vein occlusion-related macular edema


United States
China
European Union
Australia
Iceland
Liechtenstein
Norway


Calcitonin gene-related peptide type 1 receptor

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


Anemia, Refractory, With Excess of Blasts

Squamous Cell Carcinoma of Head and Neck

United States
European Union
Japan
Iceland
Liechtenstein
Norway


United States
China
Japan
United Kingdom
Canada


China
Japan
United Kingdom
Australia
Austria
Belgium
Cyprus
Czechia
Germany
Denmark
Spain
Finland
France
Greece
Hungary
Ireland
Iceland
Italy
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Sweden
Slovenia
Slovakia


United States
European Union
Australia
Iceland
Liechtenstein
Norway


Philadelphia chromosome positive chronic myelogenous leukemia

Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia

United States
China
European Union
Japan
Canada
Israel
Iceland
Liechtenstein
Norway


Hydrocodone Bitartrate and Acetaminophen


Extramedullary Disease in Multiple Myeloma

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


RET Mutation-Positive Medullary Thyroid Cancer

Advanced Thyroid Gland Medullary Carcinoma

Metastatic Thyroid Gland Medullary Carcinoma

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Locally Advanced Head and Neck Squamous Cell Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Locally Advanced Pancreatic Adenocarcinoma

Metastatic castration-resistant prostate cancer

Resectable Lung Non-Small Cell Carcinoma

United States
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Refractory Indolent Adult Non-Hodgkin Lymphoma

Refractory Indolent Non-Hodgkin Lymphoma


duodenal ulcer due to anti-platelet agent

Duodenal ulcer caused by Helicobacter pylori

United States
China
European Union
Japan
Australia
Austria
Belgium
Germany
Denmark
Spain
Finland
France
Greece
Ireland
Iceland
Italy
Liechtenstein
Luxembourg
Netherlands
Norway
Portugal
Sweden


European Union
United Kingdom
Iceland
Liechtenstein
Norway


CD19-positive B-cell acute lymphoblastic leukemia

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Refractory T Acute Lymphoblastic Leukemia


Constitutional delay of growth and puberty


United States
China
Japan
Australia
Brazil
South Korea


Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Monoclonal Gammopathy of Undetermined Significance

Recurrent Childhood Acute Lymphoblastic Leukemia

Squamous Cell Carcinoma of Head and Neck

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


CD20 Positive B-Cell Chronic Lymphocytic Leukemia

Chronic lymphocytic leukaemia refractory

Recurrent Central Nervous System Lymphoma

Refractory Central Nervous System Lymphoma

Secondary Central Nervous System Lymphoma

Anti-myelin-associated glycoprotein associated polyneuropathy

Recurrent Transformed Chronic Lymphocytic Leukemia

Refractory Transformed Chronic Lymphocytic Leukemia

Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma

Diffuse large B-cell lymphoma refractory

United States
China
European Union
Japan
United Kingdom
Canada
Australia
India
United Arab Emirates
Brazil
Switzerland
Chile
Ecuador
Israel
Iceland
South Korea
Liechtenstein
Norway
Russia
Saudi Arabia
Singapore
Thailand
Uruguay


Human fibrinogen (Shanxi Kangbao Biological Product Co. Ltd.)


Recombinant coagulation factor VIII (Rongsheng Pharmaceuticals)


Necitumumab (genetical recombination) (JAN)

Locally Advanced Lung Non-Small Cell Carcinoma

EGFR positive non-small cell lung cancer

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma


Recombinant human glucagon-like peptide-1 analogue

Metabolic Dysfunction Associated Steatohepatitis


Testosterone undecanoate depot injection

Metastatic castration-resistant prostate cancer


Insulin Degludec biosimilar(Zhuhai United Laboratories)


Recombinant Ad-p53 anti-cancer injection

Platinum-Resistant Primary Peritoneal Carcinoma


Bevacizumab biosimilar(STADA Arzneimittel AG)

European Union
Iceland
Liechtenstein
Norway


Human Follicle Stimulating Hormone-CTP Fusion Protein(Xinlitai (Genekey Biotech)


Non ST segment elevation acute coronary syndrome

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


United States
European Union
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Teriparatide Biosimilar (PharmaResearch Co., Ltd.)


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


Recombinant human thrombopoietin (Sunshine Pharmaceutical)


EGFR ex20ins mutation in non-small cell lung cancer

Locally Advanced Lung Non-Small Cell Carcinoma


Squamous cell carcinoma of head and neck metastatic

Squamous cell carcinoma of the hypopharynx

Squamous Cell Carcinoma of the Oropharynx

Metastatic Gastroesophageal Junction Adenocarcinoma

HER2 negative Gastroesophageal Junction Adenocarcinoma

Urothelial Carcinoma of the Urinary Bladder

Microsatellite instability-high colorectal cancer

Advanced Pancreatic Ductal Adenocarcinoma

Malignant neoplasm of gastro-oesophageal junction

Locally Advanced Head and Neck Squamous Cell Carcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

Metastatic Microsatellite Stable Colorectal Carcinoma

Secondary malignant neoplasm of peritoneum

Colorectal Cancer, Hereditary Nonpolyposis, Type 1

HER2 positive Gastroesophageal Junction Adenocarcinoma

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Locally Advanced Malignant Solid Neoplasm

Locally Advanced Pancreatic Adenocarcinoma

Metastatic Carcinoma to the Uterine Cervix

Metastatic Digestive System Neuroendocrine Tumor G1

Metastatic Urethral Urothelial Carcinoma

Nasopharyngeal Keratinizing Squamous Cell Carcinoma

Neck Squamous Cell Carcinoma of Unknown Primary

Recurrent Childhood Acute Lymphoblastic Leukemia

Recurrent Gastroesophageal Junction Adenocarcinoma

recurrent lymphoepithelioma of the oropharynx

Recurrent Malignant Extragonadal Germ Cell Tumor

recurrent metastatic squamous neck cancer with occult primary

Recurrent Squamous Cell Carcinoma of the Head and Neck

Relapsed Oral Cavity Mucoepidermoid Carcinoma

Relapsed Squamous Cell Carcinoma of the Larynx

Relapsed Undifferentiated Carcinoma of the Nasopharynx

Squamous cell carcinoma of the oral cavity recurrent

thyroid gland poorly differentiated carcinoma

Undifferentiated carcinoma of nasopharynx

United States
China
Japan
Canada
Australia
Brazil


Golimumab Biosimilar (Bio-Thera Solutions, Ltd.)

Polyarticular Juvenile Idiopathic Arthritis


Human immunodeficiency virus type 1 protease


Attention Deficit Disorder With Hyperactivity


Insulin glargine biosimilar(Jiangsu Wanbang Biopharmaceuticals Co., Ltd.)


Rituximab biosimilar (Chia-tai Tianqing)

Rituximab Biosimilar (Chia Tai Tianqing Pharmaceutical Group Co., Ltd.)

利妥昔单抗生物类似药（Chia Tai Tianqing Pharmaceutical Group Co., Ltd.）

CD20 positive Diffuse Large B-Cell Lymphoma


Inactivated SARS-CoV-2 vaccine (Vero cell) (Beijing Bio-Institute)

Inactivated vaccine
Prophylactic vaccine

China
United Arab Emirates
Iran
Philippines


Rituximab biosimilar (Innovent Biologics)

Rituximab Biosimilar (Eli Lilly & Co./Innovent Biologics (Suzhou) Co. Ltd.)

利妥昔单抗生物类似药（Eli Lilly & Co./Innovent Biologics (Suzhou) Co. Ltd.）


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-small cell lung cancer

Locally Advanced Lung Non-Small Cell Carcinoma

Locally Advanced Malignant Solid Neoplasm


United States
China
Japan
Belgium
Brazil
Germany
Spain
France
Italy
South Korea
Luxembourg
Netherlands
Sweden
Taiwan Province


Transient receptor potential cation channel subfamily A member 1

Transient receptor potential cation channel subfamily M member 8


Thrombomodulin Alfa (Genetical Recombination)

Thrombomodulin (human 498-amino acid fragment)

Thrombomodulin alfa (genetical recombination) (JAN)


Duodenal ulcer caused by Helicobacter pylori


Anti-PD-L1 monoclonal antibody ( Apollomics/Chia Tai Tianqing Pharmaceutical Group)

PD-L1 antibody ( Apollomics/Chia Tai Tianqing Pharmaceutical Group)

Advanced Lung Non-Small Cell Squamous Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

Resectable Lung Non-Small Cell Carcinoma

Advanced Esophageal Squamous Cell Carcinoma

Metastatic Carcinoma to the Uterine Cervix

Advanced Triple-Negative Breast Carcinoma

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

Locally Advanced Unresectable Gastric Adenocarcinoma

Metastatic Triple-Negative Breast Carcinoma

Primary mediastinal large B-cell lymphoma recurrent

Recurrent Squamous Cell Carcinoma of the Head and Neck

Recurrent Triple-Negative Breast Carcinoma

Squamous Cell Carcinoma of Head and Neck

Squamous cell carcinoma of head and neck metastatic


Chronic lymphocytic leukaemia refractory


Chronic rhinosinusitis with nasal polyps

Asthma, Nasal Polyps, and Aspirin Intolerance

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


Sodium voltage-gated channel alpha subunits

Corticosteroid 11-beta-dehydrogenase isozyme 1

Transient receptor potential cation channel subfamily A member 1

Transient receptor potential cation channel subfamily M member 8


那可丁/DL-甲基麻黄碱盐酸盐/马来酸氯苯那敏/愈创甘油醚/右美沙芬氢溴酸盐水合物

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


24-163 fibroblast growth factor 7 (human)

Recombinant human fibroblast growth factor-7

Recombinant human keratinocyte growth factor

Aggressive-Phase Chronic Myelocytic Leukemia

Anemia, Refractory, With Excess of Blasts

Blast Phase Chronic Granulocytic Leukemia

Refractory cytopenia with multilineage dysplasia

Locally Advanced Head and Neck Squamous Cell Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Steroid Refractory Graft Versus Host Disease


Philadelphia chromosome positive chronic myelogenous leukemia

Acute myeloid leukemia with mutated NPM1

Treatment related acute myeloid leukaemia

Core binding factor acute myeloid leukemia

Chronic lymphocytic leukaemia refractory

Acute Myeloid Leukemia with FLT3/ITD Mutation

Adult acute myeloid leukemia with del(5q)

Diffuse large B-cell lymphoma refractory

Malignant neoplasm of gastro-oesophageal junction

Platinum-Resistant Epithelial Ovarian Carcinoma

Platinum-Resistant Fallopian Tube Carcinoma

Recurrent Anaplastic Large Cell Lymphoma

Simian Acquired Immunodeficiency Syndrome

Squamous cell carcinoma of head and neck metastatic

Transitional cell cancer of the renal pelvis and ureter recurrent


Tumor necrosis factor ligand superfamily member 13


T-cell/histiocyte rich large B-cell lymphoma

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

Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Recurrent Central Nervous System Lymphoma

Secondary Central Nervous System Lymphoma

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


CD19-directed chimeric antigen receptor T cell therapy

anti-CD19-EGFRt-4-1BB-zeta modified CAR CD8+ and CD4+ T lymphocyte therapy

anti-CD19/EGFRt/4-1BB/zeta modified CAR CD8+ and CD4+ T lymphocyte therapy

Diffuse large B-cell lymphoma refractory

Primary mediastinal large B-cell lymphoma recurrent

Primary mediastinal large B-cell lymphoma refractory

Chronic lymphocytic leukaemia refractory

Refractory Indolent Non-Hodgkin Lymphoma

Refractory Aggressive Non-Hodgkin Lymphoma

Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma

United States
European Union
Japan
Canada
Iceland
Liechtenstein
Norway


United States
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Polyarticular Juvenile Idiopathic Arthritis

Systemic onset juvenile chronic arthritis

Juvenile Pauciarticular Chronic Arthritis


Denosumab (genetical recombination) (JAN)

Tumor necrosis factor ligand superfamily member 11

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Urothelial Carcinoma of the Urinary Bladder


United States
European Union
Iceland
South Korea
Liechtenstein
Norway


Obinutuzumab (genetical recombination) (JAN)

CD20 Positive B-Cell Chronic Lymphocytic Leukemia

Metastatic Microsatellite Stable Colorectal Carcinoma

Diffuse large B-cell lymphoma refractory

CD20 positive Diffuse Large B-Cell Lymphoma

Microcephalic Osteodysplastic Primordial Dwarfism, Type 1

Recurrent Aggressive Non-Hodgkin Lymphoma

Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Refractory Aggressive Non-Hodgkin Lymphoma

Refractory Indolent Non-Hodgkin Lymphoma

Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

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


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


Peripheral T-cell lymphoma unspecified refractory

CD19-positive B-cell acute lymphoblastic leukemia

Peripheral T-cell lymphoma unspecified recurrent

Recurrent NK-Cell Lymphoma, Unclassifiable

Refractory NK-Cell Lymphoma, Unclassifiable

Recurrent Anaplastic Large Cell Lymphoma

Locally Advanced Malignant Solid Neoplasm

Squamous cell carcinoma of head and neck metastatic


United States
European Union
Japan
United Kingdom
Canada
United Arab Emirates
Argentina
Chile
Colombia
Israel
Iceland
Liechtenstein
Mexico
Norway
Peru
Saudi Arabia


Enfortumab Vedotin (Genetical Recombination)

Muscle Invasive Bladder Urothelial Carcinoma

Renal Pelvis and Ureter Urothelial Carcinoma

Metastatic castration-resistant prostate cancer

Urothelial Carcinoma of the Urinary Bladder


CD20 Positive B-Cell Non-Hodgkin Lymphoma

Thrombotic Thrombocytopenic Purpura, Acquired

Chronic idiopathic thrombocytopenic purpura

CD20 positive Diffuse Large B-Cell Lymphoma

Chronic lymphocytic leukaemia refractory

CD20 Positive B-Cell Chronic Lymphocytic Leukemia


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


Proprotein convertase subtilisin kexin type 9


Amlodipine Besylate/Olmesartan Medoxomil/Rosuvastatin Calcium

Amlodipine besylate/olmersartan medoxomil/rosuvastatin calcium

Olmersartan medoxomil/amlodipine besilate/rosuvastatin calcium

Olmersartan medoxomil/amlodipine besylate/rosuvastatin calcium


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


Dulaglutide Biosimilar (Shandong Boan Biotechnology Co., Ltd.)


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


Acute upper respiratory tract inflammation


Idiopathic Polypoidal Choroidal Vasculopathy


Recombinant erythropoietin stimulating protein (3SBio)


Metastatic castration-resistant prostate cancer

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


Estrogen receptor positive breast cancer

Refractory Indolent Non-Hodgkin Lymphoma

Squamous cell carcinoma of head and neck metastatic


对乙酰氨基酚/马来酸氯苯那敏/盐酸甲基麻黄碱/盐酸伪麻黄碱/氢溴酸右美沙芬/愈创甘油醚

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


Modified recombinant human C-type natriuretic peptide

Vosoritide (genetical recombination) (JAN)

Atrial natriuretic peptide receptor type B

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


对乙酰氨基酚/愈创甘油醚/柠檬酸喷托维林/盐酸苯肾上腺素/马来酸氯苯那敏/无水咖啡因

Acetaminophen/Guaifenesin/Pentoxyverine Citrate/Phenylephrine Hydrochloride/Chlorpheniramine Maleate/Anhydrous Caffeine


BCR-ABL Negative Atypical Chronic Myeloid Leukemia

Blast Phase Chronic Granulocytic Leukemia

Philadelphia chromosome positive chronic myelogenous leukemia


Recombinant humanized anti-PD-1 monoclonal antibody(Sino Cell Technologies, Inc.)

Recurrent Squamous Cell Carcinoma of the Head and Neck

Advanced Esophageal Squamous Cell Carcinoma

Advanced Lung Non-Small Cell Squamous Carcinoma


United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Dementia due to Alzheimer's disease (disorder)

Sleep Initiation and Maintenance Disorders

China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Peihuaxi hippocampal peptide(Jiangsu Hansoh Pharmaceutical)


Anti-PD-1 monoclonal antibody(Henlix Biotech)

Recombinant humanized anti-PD-1 monoclonal antibody(Henlix Biotech)

Microsatellite Instability-high Solid Tumors

PD-L1 positive Esophageal Squamous Cell Carcinoma

Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Locally Advanced Esophageal Squamous Cell Carcinoma

Squamous Cell Carcinoma of Head and Neck

China
European Union
United Kingdom
India
Indonesia
Iceland
Cambodia
Liechtenstein
Malaysia
Norway
Peru
Singapore
Thailand


Aflibercept Biosimilar (Samsung Bioepis Co., Ltd.)

Retinal vein occlusion-related macular edema

United States
European Union
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


[1R-(exo,exo)]-3-(benzoyloxy)-8-methyl-8-azabicyclo[3.2.1]octane-2-carboxylic acid, methyl ester


Isophane Protamine Recombinant Human Insulin(Hefei Tianmai Biotechnology Development Co., Ltd.)


United States
China
European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


United States
European Union
United Kingdom
Iceland
Liechtenstein
Norway


Ranibizumab  Biosimilar (Samsung Bioepis Co., Ltd.)

Proliferative retinopathy with diabetes mellitus


China
European Union
Japan
Canada
Australia
Spain
Iceland
South Korea
Liechtenstein
Norway


Human immunodeficiency virus type 1 protease

United States
European Union
Iceland
Liechtenstein
Norway


Somatropin biosimilar (BioPartners GmbH)


Tocilizumab Biosimilar (Celltrion, Inc.)

Polyarticular Juvenile Idiopathic Arthritis

Systemic onset juvenile chronic arthritis


4,4'-bi-1,3-benzodioxole)-5-carboxylic acid, 5'-(hydroxymethyl)-7,7'-dimethoxy-, methyl ester


Tumor necrosis factor ligand superfamily member 11

European Union
Iceland
Liechtenstein
Norway


对乙酰氨基酚/盐酸苯海拉明/盐酸伪麻黄碱/氢溴酸右美沙芬水合物/盐酸甲基麻黄碱/愈创甘油醚/核黄素/抗坏血酸/甘氨酸

Acetaminophen/Diphenhydramine Hydrochloride/Pseudoephedrine Hydrochloride/Dextromethorphan Hydrobromide Hydrate/DL-Methylephedrine Hydrochloride/Guaifenesin/Riboflavin/Ascorbic Acid/Glycine


Radiopharmaceuticals and diagnostic agent


Trametinib dimethyl sulfoxide (JAN/USAN)

Dual specificity mitogen-activated protein kinase kinase 1

Dual specificity mitogen-activated protein kinase kinase 2

BRAF mutation positive hairy cell leukemia

BRAF V600E mutation-positive low grade glioma

BRAF Mutation Non-small Cell Lung Cancer

BRAF V600E Mutation-Positive Solid Tumors

BRAF V600 Mutation-Positive Non-small Cell Lung Cancer

BRAF V600E mutant Non-small Cell Lung Cancer

BRAF V600E Mutation-Positive Anaplastic Thyroid Cancer

Recurrent Primary Peritoneal Serous Adenocarcinoma

Glioblastoma Harboring BRAF V600 Mutation

Metastatic castration-resistant prostate cancer

thyroid gland poorly differentiated carcinoma

Unresectable Lung Non-Small Cell Carcinoma

Locally Advanced Malignant Solid Neoplasm

Diffuse midline glioma, point mutation K27M in histone H3

Advanced Lung Non-Small Cell Squamous Carcinoma

Advanced Triple-Negative Breast Carcinoma

BRAF V600K Mutation-Positive Solid Tumors

Colorectal Cancer, Hereditary Nonpolyposis, Type 1

Desmoplastic Cerebral Astrocytoma of Infancy

Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma

MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer

Metastatic Triple-Negative Breast Carcinoma

Microsatellite instability-high colorectal cancer

Recurrent Childhood Acute Lymphoblastic Leukemia

Squamous Cell Carcinoma of Head and Neck

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


Human immunodeficiency virus type 1 Pol protein


Recombinant lispro insulin biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

Insulin lispro Biosimilar (Gan & Lee Pharmaceuticals Co., Ltd.)


ER-positive/HER2-negative/ ESR1-mutated breast cancer

PIK3CA H1047R mutant ER-positive, HER2-negative Breast Cancer

Hormone receptor positive HER2 negative breast cancer

United States
European Union
Japan
United Kingdom
Iceland
Liechtenstein
Norway


Metastatic castration-resistant prostate cancer

Synthetic peptide
Diagnostic radiopharmaceuticals


Philadelphia chromosome positive chronic myelogenous leukemia

Recurrent Platinum-Resistant Ovarian Carcinoma


Pamiteplase (genetical recombination) (JAN)


Chronic Kidney Disease-Associated Pruritus

Chemotherapy-induced nausea and vomiting


Voltage-gated calcium channel alpha2/delta subunit 1

Voltage-gated calcium channel alpha2/delta subunit 2


Peptide Conjugate Radionuclide
Diagnostic radiopharmaceuticals


thyroid gland poorly differentiated carcinoma

United States
European Union
Japan
Iceland
Liechtenstein
Norway


Zolmitriptan Intracutaneous Microneedle System


Complicated skin and soft tissue infection


Sleep Initiation and Maintenance Disorders

United States
Japan
United Kingdom
Belgium
Czechia
Germany
France
Hungary
Ireland
Iceland
Italy
Luxembourg
Latvia
Netherlands
Norway
Poland
Portugal
Sweden
Slovenia


PD-L1 positive Non-Small Cell Lung Cancer

EGFR positive Non-squamous non-small cell lung cancer

Advanced Lung Non-Small Cell Squamous Carcinoma

Squamous Cell Carcinoma of Head and Neck

PD-L1 negative Triple Negative Breast Cancer

Recurrent Squamous Cell Carcinoma of the Head and Neck

Squamous cell carcinoma of head and neck metastatic

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Advanced Triple-Negative Breast Carcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

Metastatic Triple-Negative Breast Carcinoma

PD-L1-positive head and neck squamous cell carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Microsatellite Stable Colorectal Carcinoma

Advanced Head and Neck Squamous Cell Carcinoma

Cutaneous Squamous Cell Carcinoma of the Head and Neck

HR Positive/HER2 Negative Lobular Carcinoma

HER2 negative Gastroesophageal Junction Adenocarcinoma

Metastatic Clear Cell Renal Cell Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

Resectable Lung Non-Small Cell Carcinoma


Cetuximab biosimilar (Zhangjiang Biotech)

Cetuximab Biosimilar (Shanghai Zhangjiang Biotechnology Co. Ltd.)


Interstitial lung disease due to systemic disease

Blastic Plasmacytoid Dendritic Cell Neoplasm

Refractory Adult Acute Lymphoblastic Leukemia

Refractory Acute Undifferentiated Leukemia

Blast Phase Chronic Granulocytic Leukemia

Anemia, Refractory, With Excess of Blasts

Recurrent Childhood Acute Lymphoblastic Leukemia

Aggressive-Phase Chronic Myelocytic Leukemia

Philadelphia chromosome positive chronic myelogenous leukemia

Recurrent Mixed Phenotype Acute Leukemia

Refractory Mixed Phenotype Acute Leukemia

Acute myeloid leukaemia with 11q23 abnormality

Acute myeloid leukemia with multilineage dysplasia

Acute Myeloid Leukemia with Myelodysplasia-Related Changes

Adult Acute Monoblastic and Monocytic Leukemia

Adult acute myeloid leukemia with del(5q)

AIDS-Related Diffuse Large Cell Lymphoma

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

BCR-ABL Negative Atypical Chronic Myeloid Leukemia

Childhood Nodular Sclerosis Classic Hodgkin Lymphoma

Chronic lymphocytic leukaemia refractory

Human Papillomavirus-Related Cervical Carcinoma

pediatric lymphoblastic non-Hodgkin's lymphoma

Primary Cutaneous Anaplastic Large Cell Lymphoma

Purine Nucleoside Phosphorylase Deficiency

Recurrent Adult Acute Lymphoblastic Leukemia

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 cytopenia with multilineage dysplasia and ringed sideroblasts

Stage II Non-Contiguous Adult Diffuse Small Cleaved Cell Lymphoma

Treatment related acute myeloid leukaemia

untreated pediatric acute nonlymphocytic leukemia

X-Linked Combined Immunodeficiency Diseases


Ranibizumab  Biosimilar (Teva Canada Ltd.)


Retinal vein occlusion-related macular edema

Proliferative retinopathy with diabetes mellitus

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


Vascular endothelial growth factor gene therapy


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


Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type

T-cell/histiocyte rich large B-cell lymphoma

CD20 Positive B-Cell Chronic Lymphocytic Leukemia

Chronic lymphocytic leukaemia refractory

Monoclonal Gammopathy of Undetermined Significance

CD20 positive Diffuse Large B-Cell Lymphoma

Recurrent Central Nervous System Lymphoma

Secondary Central Nervous System Lymphoma

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

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

Advanced Head and Neck Squamous Cell Carcinoma

Recurrent Transformed Chronic Lymphocytic Leukemia

Urothelial Carcinoma of the Urinary Bladder

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


Intraoperative floppy iris syndrome (IFIS)


Pertuzumab Biosimilar (Alkem Laboratories Ltd.)


United States
China
Japan
Canada
Argentina
Germany
Spain
Italy


Neurotrophic tyrosine kinase receptor type 2

Neurotrophic tyrosine kinase receptor type 3

Locally Advanced Malignant Solid Neoplasm


Metastatic HER2-Negative Breast Carcinoma

Human epidermal growth factor 2 negative carcinoma of breast

Squamous cell carcinoma of head and neck metastatic

Squamous cell carcinoma of the hypopharynx

Squamous Cell Carcinoma of the Oropharynx

Primary Peritoneal Low-Grade Serous Adenocarcinoma

Primary Peritoneal Serous Adenocarcinoma

Neck Squamous Cell Carcinoma of Unknown Primary

Renal Pelvis and Ureter Urothelial Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Unresectable Lung Non-Small Cell Carcinoma

Human Papillomavirus-Related Head and Neck Neoplasms

Fallopian Tube High Grade Serous Adenocarcinoma

high grade serous adenocarcinoma of ovary

Primary Peritoneal High-Grade Serous Adenocarcinoma

Refractory Primary Peritoneal Serous Adenocarcinoma

thyroid gland poorly differentiated carcinoma

Estrogen receptor-negative breast cancer

progesterone receptor-negative breast cancer

Advanced Triple-Negative Breast Carcinoma

Squamous Cell Carcinoma of Head and Neck

Metastatic Esophageal Squamous Cell Carcinoma

Metastatic Gastroesophageal Junction Adenocarcinoma

Oesophageal squamous cell carcinoma recurrent

Recurrent Gastroesophageal Junction Adenocarcinoma

Recurrent Squamous Cell Carcinoma of the Head and Neck

Relapsed Squamous Cell Carcinoma of the Larynx

Squamous cell carcinoma of the oral cavity recurrent

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Urothelial Carcinoma of the Urinary Bladder

Metastatic Triple-Negative Breast Carcinoma

Secondary malignant neoplasm of peritoneum

Primary Peritoneal Endometrioid Adenocarcinoma

Locally Advanced Malignant Solid Neoplasm

Malignant neoplasm of gastro-oesophageal junction

Estrogen receptor positive breast cancer

Platinum-Resistant Epithelial Ovarian Carcinoma

Recurrent Platinum-Resistant Primary Peritoneal Carcinoma

Advanced Esophageal Squamous Cell Carcinoma

Advanced Lung Non-Small Cell Squamous Carcinoma

EGFR positive Non-squamous non-small cell lung cancer

Fallopian Tube Clear Cell Adenocarcinoma

HER2 Positive Adenocarcinoma of Esophagus

Hereditary Breast and Ovarian Cancer Syndrome

Hormone receptor negative HER2 positive breast cancer

Hormone receptor positive HER2 negative breast cancer

Hormone receptor positive HER2 positive breast cancer

HPV positive oropharyngeal squamous cell carcinoma

HR Positive/HER2 Negative/Node positive breast cancer

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Locally Advanced Head and Neck Squamous Cell Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Locally Advanced Pancreatic Adenocarcinoma

Locally Advanced Unresectable Gastric Adenocarcinoma

Metastatic Carcinoma to the Uterine Cervix

Metastatic castration-resistant prostate cancer

Metastatic Digestive System Neuroendocrine Tumor G1

Non-Muscle Invasive Bladder Urothelial Carcinoma

PD-L1 positive Triple Negative Breast Cancer

Platinum-sensitive epithelial ovarian cancer

Platinum-Sensitive Fallopian Tube Carcinoma

Recurrent Adult Grade III Lymphomatoid Granulomatosis

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

recurrent metastatic squamous neck cancer with occult primary

Recurrent Ovarian Clear Cell Adenocarcinoma

Recurrent Ovarian Undifferentiated Carcinoma

Recurrent Platinum-Resistant Fallopian Tube Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

recurrent primary peritoneal cavity cancer

Recurrent Primary Peritoneal Clear Cell Adenocarcinoma

Relapsed Oral Cavity Mucoepidermoid Carcinoma

Resectable Lung Non-Small Cell Carcinoma

Stage II Non-Contiguous Adult Diffuse Small Cleaved Cell Lymphoma

Transitional cell cancer of renal pelvis and ureter metastatic

Transitional cell cancer of the renal pelvis and ureter recurrent

China
European Union
Japan
Brazil
Iceland
South Korea
Liechtenstein
Norway


United States
China
European Union
Japan
Australia
Brazil
Iceland
Liechtenstein
Norway


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


Sodium voltage-gated channel alpha subunits

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Ventilator associated bacterial pneumonia

Complicated skin and skin structure infection

MRSA - Methicillin resistant Staphylococcus aureus infection

Skin structures and soft tissue infections


Insulin aspart biosimilar (Zhejiang Hisun)


Autologous cultured chondrocytes (Vericel)

Autologous cultured chondrocytes on porcine collagen membrane

Matrix-induced autologous chondrocyte implant


United States
China
European Union
Japan
Iceland
Liechtenstein
Norway


Chronic lymphocytic leukaemia refractory

Recurrent Transformed Chronic Lymphocytic Leukemia

Refractory Transformed Chronic Lymphocytic Leukemia


United States
European Union
Australia
Iceland
South Korea
Liechtenstein
Norway


Autologous CRISPR-Cas9 modified CD34+ hHSPCs

United States
European Union
United Kingdom
Canada
Bahrain
Iceland
Liechtenstein
Norway
Saudi Arabia


Locally Advanced Lung Non-Small Cell Carcinoma

Diffuse large B-cell lymphoma refractory

Precursor B-lymphoblastic lymphoma/leukemia refractory

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent B Acute Lymphoblastic Leukemia

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

Refractory B Acute Lymphoblastic Leukemia

T-cell acute lymphoblastic leukemia in relapse

T-cell/histiocyte rich large B-cell lymphoma


HER2 positive Gastroesophageal Junction Adenocarcinoma

HER2 Positive Adenocarcinoma of Esophagus

Hormone receptor positive HER2 positive breast cancer

Locally Advanced Head and Neck Squamous Cell Carcinoma

Locally Advanced Malignant Solid Neoplasm

Locally Advanced Pancreatic Adenocarcinoma

Metastatic Carcinoma to the Uterine Cervix

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Platinum-sensitive epithelial ovarian cancer

Squamous Cell Carcinoma of Head and Neck

Squamous Cell Carcinoma of the Oropharynx

Urothelial Carcinoma of the Urinary Bladder

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


Human Thyrotropin beta  (Zelgen Biopharma)

Recombinant human thyrotropin (Zelgen Biopharma)


European Union
Iceland
Liechtenstein
Norway


Insulin human (rDNA origin, Novo Nordisk)

INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN

INSULIN ZINC SUSP SEMISYNTHETIC PURIFIED HUMAN

Isophane Protamine Recombinant Human Insulin(Novo Nordisk Pharmaceuticals Pty Ltd.)

China
European Union
Japan
Iceland
Liechtenstein
Norway


Emtricitabine and Tenofovir Alafenamide Fumarate

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


Multidrug resistant pulmonary tuberculosis

United States
China
European Union
Japan
Iceland
South Korea
Liechtenstein
Norway


Maturity-Onset Diabetes of the Young, Type 2

Metabolic Dysfunction Associated Steatohepatitis


Hypertrophic Cardiomyopathy without Obstruction

Heart failure with normal ejection fraction

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


Recombinant two component COVID-19 vaccine (Jiangsu Rec-Biotechnology)

Recombinant two-component COVID-19 vaccine (CHO cell) (Recbio)


Recombinant human interferon α2b(Lee's Pharmaceutical Holdings Ltd.)

Interferon alpha-2b (Lee's Pharmaceutical)


Metabolic dysfunction-associated steatotic liver disease

United States
China
Japan
Austria
Germany
Portugal


Human BCMA chimeric antigen receptor autologous T cell(Innovent Biologics (Suzhou) Co. Ltd.)

AQP4-IgG positive Neuromyelitis optica spectrum disorder

Myelin oligodendrocyte glycoprotein antibody-associated disease

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating


Muscle Invasive Bladder Urothelial Carcinoma

Renal Pelvis and Ureter Urothelial Carcinoma


Transient receptor potential cation channel subfamily A member 1

Transient receptor potential cation channel subfamily M member 8


Platelet-derived growth factor receptor alpha

Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia

Philadelphia chromosome positive chronic myeloid leukemia in blast crisis

Philadelphia chromosome-positive chronic myeloid  leukemia in chronic phase

Metastatic Gastrointestinal Stromal Tumor

Philadelphia Chromosome Positive Leukemia

Unresectable Gastrointestinal Stromal Tumor

Platelet-derived growth factor receptor gene re-arrangement Myelodysplastic/Myeloproliferative Diseases

Malignant Gastric Gastrointestinal Stromal Tumor

Philadelphia chromosome-positive acute lymphoblastic leukemia in relapse

Philadelphia positive acute lymphocytic leukaemia

Philadelphia chromosome positive chronic myelogenous leukemia

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Congenital Bone Marrow Failure Syndromes

Platelet Disorder, Familial, With Associated Myeloid Malignancy

Squamous Cell Carcinoma of Head and Neck

Aggressive-Phase Chronic Myelocytic Leukemia

BCR-ABL Negative Atypical Chronic Myeloid Leukemia

BCR-ABL1 positive Acute Lymphoblastic Leukemia

Blast Phase Chronic Granulocytic Leukemia

childhood malignant fibrous histiocytoma of bone

Chronic lymphocytic leukaemia refractory

Metastatic castration-resistant prostate cancer

Metastatic Thyroid Gland Medullary Carcinoma

Monoclonal Gammopathy of Undetermined Significance

PDGFRA D842V mutation Gastrointestinal Stromal Tumors

Peripheral Primitive Neuroectodermal Tumors

Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia

Platinum-Resistant Primary Peritoneal Carcinoma

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Childhood Acute Lymphoblastic Leukemia

Recurrent Squamous Cell Carcinoma of the Head and Neck

Refractory Acute Undifferentiated Leukemia

Stage II Non-Contiguous Adult Diffuse Small Cleaved Cell Lymphoma

Steroid Refractory Graft Versus Host Disease

Unresectable Pleural Malignant Mesothelioma


Immunoglobulin G4, anti-(human blood-coagulation factor viia) (human monoclonal CSL312 gamma4-chain), disulfide with human monoclonal CSL312 lambda-chain, dimer

United States
European Union
Japan
United Kingdom
Australia
Iceland
Liechtenstein
Norway


Bevacizumab biosimilar(Jiangsu Hengrui Pharmaceuticals Co., Ltd.)

Locally Advanced Malignant Solid Neoplasm


Platinum-Resistant, ARID1A-Mutated Ovarian Carcinoma

Recurrent Primary Peritoneal Endometrioid Adenocarcinoma

Diffuse midline glioma, point mutation K27M in histone H3

Pancreatic neuroendocrine tumour metastatic

Secondary Central Nervous System Lymphoma

Well Differentiated Pancreatic Endocrine Tumor

Metastatic Microsatellite Stable Colorectal Carcinoma

Refractory Central Nervous System Lymphoma

Acute myeloid leukaemia with 11q23 abnormality

Advanced Pancreatic Neuroendocrine Tumor

Childhood Central Nervous System Neoplasm

Locally Advanced Lung Non-Small Cell Carcinoma

Metastatic Digestive System Neuroendocrine Tumor G1

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Metastatic Malignant Neoplasm to the Leptomeninges

Microsatellite instability-high colorectal cancer

Neuroendocrine neoplasm of gastrointestinal tract

Non Functioning Pancreatic Endocrine Tumor

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Anaplastic (Malignant) Meningioma

Recurrent Childhood Acute Lymphoblastic Leukemia

Recurrent Childhood Spinal Cord Neoplasm

Treatment related acute myeloid leukaemia

Unresectable Gastrointestinal Stromal Tumor


Aggressive-Phase Chronic Myelocytic Leukemia

Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia

Philadelphia chromosome-positive chronic myeloid  leukemia in chronic phase

Philadelphia chromosome positive chronic myelogenous leukemia

Philadelphia positive acute lymphocytic leukaemia

Blast Phase Chronic Granulocytic Leukemia

Metastatic Gastrointestinal Stromal Tumor

PDGFRA D842V mutation Gastrointestinal Stromal Tumors

Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia

Philadelphia Chromosome Positive Leukemia

Philadelphia chromosome-positive acute lymphoblastic leukemia in relapse

Steroid Refractory Graft Versus Host Disease

United States
China
European Union
Japan
Australia
Switzerland
Iceland
Liechtenstein
Norway


Pegvisomant (genetical recombination) (JAN)

United States
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Sodium voltage-gated channel alpha subunits

Multiple Sclerosis, Secondary Progressive


Potassium Azilsartan Medoxomil/Amlodipine Besylate


Attention Deficit Disorder With Hyperactivity

Squamous cell carcinoma of the oral cavity

Squamous Cell Carcinoma of the Oropharynx

United States
China
Japan
United Kingdom


Recombinant human anti-PDL1 monoclonal antibody(CStone Pharmaceuticals Co. Ltd.)

重组抗PD-L1全人单克隆抗体(CStone Pharmaceuticals Co. Ltd.)

PD-L1 positive Non-Small Cell Lung Cancer

Unresectable Lung Non-Small Cell Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Resectable Lung Non-Small Cell Carcinoma

Locally Advanced Esophageal Squamous Cell Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Locally Advanced Unresectable Gastric Adenocarcinoma

Unresectable Esophageal Squamous Cell Carcinoma

China
European Union
United Kingdom
Iceland
Liechtenstein
Norway


Nuclear factor erythroid 2-related factor 2

United States
European Union
United Kingdom
Australia
Switzerland
Iceland
Liechtenstein
Norway


United States
European Union
Australia
Iceland
Liechtenstein
Norway


Recombinant Human Follitropin (Qilu Pharma)

Follitropin Alfa  Biosimilar (Qilu Pharmaceutical Co., Ltd.)

Female infertility associated with anovulation


Alemtuzumab (genetical recombination) (JAN)

CD22 Positive B-cell Acute Lymphoblastic Leukemia

Chronic lymphocytic leukaemia refractory

Philadelphia positive acute lymphocytic leukaemia

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Recurrent Adult Acute Lymphoblastic Leukemia

Refractory B-Cell Prolymphocytic Leukemia


Hepatitis C virus (HCV) nonstructural protein 3

Hepatitis C virus NS5B RNA-dependent RNA polymerase


Tocopherol Acetate/Magnesium Oxide/Pyridoxine Hydrochloride/Benfotiamine/Riboflavin/Gamma-Oryzanol/Cyanocobalamin


United States
China
Japan
Brazil
South Korea


Heart failure with normal ejection fraction


Peroxisome proliferator-activated receptor α


Irinotecan Hydrochloride Lioposome (Ouyi)

Advanced Esophageal Squamous Cell Carcinoma


Panitumumab (genetical recombination) (JAN)

Advanced Triple-Negative Breast Carcinoma

Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Colorectal Cancer, Hereditary Nonpolyposis, Type 1

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Locally Advanced Head and Neck Squamous Cell Carcinoma

Locally Advanced Pancreatic Adenocarcinoma

Mental Retardation, Autosomal Recessive 3

Metastatic Esophageal Squamous Cell Carcinoma

Platinum-Resistant Fallopian Tube Carcinoma

Recurrent Squamous Cell Carcinoma of the Head and Neck

Squamous Cell Carcinoma of Head and Neck

Unresectable Lung Non-Small Cell Carcinoma

United States
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Retinal vein occlusion-related macular edema


Methyl Salicylate/L-Menthol/Tocopherol Acetate/Vanillyl Nonylamide/Enoxolone

Src homology phosphotyrosyl phosphatase 2

Transient receptor potential cation channel subfamily A member 1

Transient receptor potential cation channel subfamily M member 8

Transient receptor potential cation channel subfamily V member 1


Immunoglobulin g1, anti-(human respiratory syncytial virus fusion protein)(human monoclonal med18897 .gamma.1-chain), disulfide with monoclonal med18897 .kappa.-chain, dimer

Immunoglobulin g1-kappa, anti-(human respiratory syncytial virus fusion glycoprotein f0 (protein f))human monoclonal antibody.gamma.1 heavy chain (1-456) (human vh (homo sapiens ighv1-69*01(ighd)-ighj4*01 (90.1%)) (8.8.19) (1-126) -homo sapiens ighg1*03

Nirsevimab (genetical recombination) (JAN)

Respiratory syncytial virus monoclonal antibody D25

Pneumonia due to respiratory syncytial virus

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


Blinatumomab (genetical recombination) (JAN)

Recurrent B Acute Lymphoblastic Leukemia

Refractory B Acute Lymphoblastic Leukemia

CD19-positive B-cell Precursor acute lymphoblastic leukemia

Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia

Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia

Philadelphia positive acute lymphocytic leukaemia

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

BCR-ABL1 positive Acute Lymphoblastic Leukemia

CD19-positive B-cell acute lymphoblastic leukemia

CD22 Positive B-cell Acute Lymphoblastic Leukemia

Aggressive-Phase Chronic Myelocytic Leukemia

Blast Phase Chronic Granulocytic Leukemia

Recurrent Childhood Acute Lymphoblastic Leukemia

Philadelphia chromosome-positive acute lymphoblastic leukemia in relapse

Refractory Adult Acute Lymphoblastic Leukemia

Burkitt-like lymphoma with 11q aberration

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

Recurrent Mixed Phenotype Acute Leukemia

Refractory Mixed Phenotype Acute Leukemia

Diffuse large B-cell lymphoma refractory

CD19 positive Diffuse Large B-Cell Lymphoma

Refractory Indolent Non-Hodgkin Lymphoma

T-cell/histiocyte rich large B-cell lymphoma

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


Sitagliptin Phosphate Hydrate/Empagliflozin L-Proline


Human hepatitis B immunoglobulin(Biotest Pharma GmbH)

Human hepatitis B immunoglobulin - Biotest AG

European Union
Iceland
Liechtenstein
Norway


Recurrent Squamous Cell Carcinoma of the Head and Neck

Systemic onset juvenile chronic arthritis

United States
China
Japan
United Kingdom
Austria
Belgium
Cyprus
Germany
Denmark
Spain
Finland
France
Greece
Ireland
Iceland
Italy
Luxembourg
Malta
Netherlands
Norway
Portugal
Sweden


Extended-release formulation of bupivacaine(Sonoran Biosciences)

Sodium voltage-gated channel alpha subunits


Locally Advanced Lung Non-Small Cell Carcinoma

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

EGFR positive non-small cell lung cancer

Estrogen receptor-negative breast cancer

Locally Advanced Head and Neck Squamous Cell Carcinoma

Locally Advanced Pancreatic Adenocarcinoma

progesterone receptor-negative breast cancer

Squamous Cell Carcinoma of Head and Neck

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Inotuzumab Ozogamicin (Genetical Recombination)

Inotuzumab ozogamicin (genetical recombination) (JAN)

Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia

Recurrent B Acute Lymphoblastic Leukemia

Refractory B Acute Lymphoblastic Leukemia

CD22 Positive B-cell Acute Lymphoblastic Leukemia

CD22 positive Acute Lymphoblastic Leukemia

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

CD22-positive B-cell Precursor acute lymphoblastic leukemia

Recurrent Childhood Acute Lymphoblastic Leukemia

CD19-positive B-cell acute lymphoblastic leukemia

Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia

CD20 positive Diffuse Large B-Cell Lymphoma

Precursor B-lymphoblastic lymphoma/leukemia refractory

Refractory Aggressive Non-Hodgkin Lymphoma


United States
European Union
Canada
Australia
Iceland
Liechtenstein
Norway


FGFR2 positive Transitional Cell Carcinoma

FGFR3 positive Transitional Cell Carcinoma

FGFR positive Transitional Cell Carcinoma

FGFR positive Non-Muscle Invasive Bladder Neoplasms

Urothelial Carcinoma of the Urinary Bladder

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


Recombinant human erythropoietin(Center of Molecular Immunology)


Refractory Langerhans Cell Histiocytosis

Aggressive-Phase Chronic Myelocytic Leukemia

Anemia, Refractory, With Excess of Blasts

Blast Phase Chronic Granulocytic Leukemia

Core binding factor acute myeloid leukemia

Philadelphia positive acute lymphocytic leukaemia

Recurrent Adult Acute Lymphoblastic Leukemia

refractory acute lymphoid leukemia in relapse

European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Bevacizumab Biosimilar (Tot Biopharm Co. Ltd.)

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma


Xylometazoline Hydrochloride/Chlorpheniramine Maleate/Glycyrrhizinate dipotassium/Cetylpyridinium Chloride Hydrate

Corticosteroid 11-beta-dehydrogenase isozyme 1


Human Fibrinogen(Shanghai RAAS Blood Products)


Dementia due to Alzheimer's disease (disorder)

Amyotrophic Lateral Sclerosis 2, Juvenile

United States
China
Japan
Canada
Australia
Switzerland
Indonesia
South Korea
Malaysia
Thailand


Small molecule drug
Other diagnostic agent


CD19-directed Chimeric Antigen Recepter T Cells

Recurrent B Acute Lymphoblastic Leukemia

Diffuse large B-cell lymphoma refractory

Refractory B Acute Lymphoblastic Leukemia


Src homology phosphotyrosyl phosphatase 2


EGFR positive non-small cell lung cancer

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Squamous Cell Carcinoma of Head and Neck

Recurrent Squamous Cell Carcinoma of the Head and Neck

Squamous cell carcinoma of head and neck metastatic

Advanced Triple-Negative Breast Carcinoma

Anemia, Refractory, With Excess of Blasts

c-Met positive non-small cell lung cancer

EGFR positive Non-squamous non-small cell lung cancer

JAK-2 V617F Positive Myeloproliferative Disorders

Locally Advanced Head and Neck Squamous Cell Carcinoma

Locally Advanced Malignant Solid Neoplasm

Locally Advanced Pancreatic Adenocarcinoma

Malignant neoplasm of gastro-oesophageal junction

Metastatic castration-resistant prostate cancer

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Metastatic Triple-Negative Breast Carcinoma

Muscle Invasive Bladder Urothelial Carcinoma

Relapsed Squamous Cell Carcinoma of the Larynx

Resectable Lung Non-Small Cell Carcinoma

Squamous cell carcinoma of the hypopharynx

Squamous cell carcinoma of the oral cavity recurrent

Squamous Cell Carcinoma of the Oropharynx

Treatment related acute myeloid leukaemia

China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Prostate Adenocarcinoma with Neuroendocrine Differentiation

Hormone receptor positive HER2 negative breast cancer


Hypoxia-inducible factor prolyl hydroxylase


Infliximab Biosimilar(Hisun Bio Pharmaceutical Co., Ltd.)

Recombinant chimeric anti-TNFα antibody(Zhejiang Hisun Pharmaceutical Co., Ltd.)


European Union
United Kingdom
Iceland
Liechtenstein
Norway


Chlorteytractcline Hydrochloride Eye Ointment

Drug-induced extrapyramidal side effects


MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer

c-Met positive non-small cell lung cancer

EGFR mutation MET positive Non-small Cell Lung Cancer

Locally Advanced Lung Non-Small Cell Carcinoma

MET gene amplification Non-small Cell Lung Cancer

Squamous Cell Carcinoma of Head and Neck

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


Prednisolone Acetate Ophthalmic Suspension


EM1-mAb DuoBody(Janssen Global Services LLC)

EGFR positive 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 ex20ins mutation in non-small cell lung cancer

Recurrent Squamous Cell Carcinoma of the Head and Neck

KRAS G12C mutant Non-small Cell Lung Cancer

Squamous cell carcinoma of head and neck metastatic


Denosumab Biosimilar (Fresenius Kabi Pharmaceuticals Holding LLC)

地舒单抗生物类似药（Fresenius Kabi Pharmaceuticals Holding LLC）

Tumor necrosis factor ligand superfamily member 11

United States
European Union
Iceland
Liechtenstein
Norway


Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma


Microsatellite Stable Colorectal Carcinoma

United States
China
Japan
United Kingdom
Austria
Belgium
Germany
Spain
Finland
France
Ireland
Italy
Netherlands
Portugal


Efgartigimod Alfa（Genetical Recombination)/Vorhyaluronidase Alfa (Genetical Recombination)

efgartigimod alfa and hyaluronidase-qvfc

efgartigimod/recombinant human hyaluronidase PH20

エフガルチギモド アルファ（遺伝子組換え）/ボルヒアルロニダーゼ アルファ（遺伝子組換え）

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating


HER2 Positive Adenocarcinoma of Esophagus

HER2 positive Gastroesophageal Junction Adenocarcinoma

HER2 Positive Gastroesophageal Adenocarcinoma

Metastatic human epidermal growth factor 2 positive carcinoma of breast

HER2 Positive Muscle Invasive Bladder Carcinoma

Malignant neoplasm of gastro-oesophageal junction

Urothelial Carcinoma of the Urinary Bladder

HER2 Positive Gastrointestinal Neoplasms

HER2 positive adenocarcinoma of biliary tract

Metastatic HER2 positive gastroesophageal junction cancer

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


Factor VIII (Hebei Da'An Pharmaceutical)


European Union
Canada
Iceland
Liechtenstein
Norway


Idiopathic pulmonary arterial hypertension

Pulmonary arterial hypertension associated with congenital heart disease

Pulmonary arterial hypertension associated with connective tissue disease

Heart failure with normal ejection fraction

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


Dual specificity mitogen-activated protein kinase kinase 1

Dual specificity mitogen-activated protein kinase kinase 2


布洛芬/无水咖啡因/DL-盐酸甲基麻黄碱/马来酸氯苯那敏/氢溴酸右美沙芬水合物/愈创甘油醚/盐酸伪麻黄碱

Ibuprofen/Anhydrous Caffeine/DL-Methylephedrine Hydrochloride/Chlorpheniramine Maleate/Dextromethorphan Hydrobromide Hydrate/Guaifenesin/Pseudoephedrine Hydrochloride


SARS-CoV-2 Spike Protein Vaccine (Recombinant) (Novavax)

COVID-19 Vaccine (recombinant, adjuvanted)

Recombinant Coronavirus (SARS-CoV-2) Vaccine(Novavax, Inc.)

SARS-CoV-2 rS (COVID-19) Nanoparticle Vaccine - Novavax

SARS-CoV-2 recombinant spike protein nanoparticle vaccine

United States
European Union
Japan
United Kingdom
Canada
Australia
India
Iceland
South Korea
Liechtenstein
Norway
New Zealand
Singapore
Thailand


Pegfilgrastim  Biosimilar (JAMP Pharma Corp.)


Bevacizumab Biosimilar (Shanghai Henlius Biotech, Inc.)

Advanced Lung Non-Squamous Non-Small Cell Carcinoma


Glycol Salicylate/L-Menthol/Vanillyl Nonylamide/Tocopherol Acetate

Transient receptor potential cation channel subfamily A member 1

Transient receptor potential cation channel subfamily M member 8

Transient receptor potential cation channel subfamily V member 1


United States
China
European Union
Japan
United Kingdom
Canada
Australia
Brazil
Iceland
Liechtenstein
Norway
South Africa
Zimbabwe


Multiple Sclerosis, Secondary Progressive


Peginterferon alfa-2b (Merck Sharp & Dohme)

Metastatic Clear Cell Renal Cell Carcinoma

Philadelphia chromosome positive chronic myelogenous leukemia

United States
China
Japan
Taiwan Province


Ventilator associated bacterial pneumonia


Voltage-gated potassium channel subunit Kv1.5

Voltage-gated potassium channel subunit Kv11.1

European Union
Canada
Switzerland
Iceland
Liechtenstein
Norway
South Africa


Platinum-sensitive epithelial ovarian cancer

Folate receptor-alpha positive, platinumresistant epithelial ovarian cancer

Folate receptor-alpha positive, platinumresistant fallopian tube cancer

Folate receptor-alpha positive, platinumresistant primary peritoneal cancer

Platinum-Resistant Epithelial Ovarian Carcinoma

Platinum-Resistant Fallopian Tube Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma

Platinum-Sensitive Fallopian Tube Carcinoma

Platinum-Sensitive Primary Peritoneal Carcinoma


Human immunodeficiency virus type 1 protease


United States
China
Japan
United Kingdom
Canada
Australia


Chlorpheniramine Maleate/Scopolamine Hydrobromide Hydrate/Nicotinamide/Pyridoxine Hydrochloride


syndrome; salt-losing, adrenogenital syndrome

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


European Union
Japan
Australia
Iceland
Liechtenstein
Norway


EGFR positive 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 mutation MET positive Non-small Cell Lung Cancer

Resectable Lung Non-Small Cell Carcinoma

Unresectable Lung Non-Small Cell Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

MET gene amplification Non-small Cell Lung Cancer

Metastatic Malignant Neoplasm to the Leptomeninges

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

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


Recombinant anti-HER2 antibody(Anhui Anke Biotech)

Germline BRCA-mutated, HER2-negative metastatic breast cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast


United States
China
European Union
Japan
Canada
Iceland
Liechtenstein
Norway


Filgrastim biosimilar(KASHIV BIOSCIENCES LLC)


Belantamab mafodotin (genetical recombination) (JAN)

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


Semaglutide  Biosimilar (NATCO Pharma Ltd.)


United States
European Union
Canada
Iceland
Liechtenstein
Norway


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


对乙酰氨基酚/愈创甘油醚/盐酸伪麻黄碱/盐酸甲基麻黄碱/氢溴酸右美沙芬/盐酸曲普利啶

Acetaminophen/Guaifenesin/Pseudoephedrine Hydrochloride/Methylephedrine Hydrochloride/Dextromethorphan Hydrobromide Hydrate/Triprolidine Hydrochloride


Hormone receptor positive HER2 negative breast cancer

Locally Advanced Malignant Solid Neoplasm