Polyarticular Juvenile Idiopathic Arthritis

Urothelial Carcinoma of the Urinary Bladder

Philadelphia chromosome positive chronic myelogenous leukemia

pediatric lymphoblastic non-Hodgkin's lymphoma

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Refractory Acute Undifferentiated Leukemia

Recurrent B Acute Lymphoblastic Leukemia

Recurrent Childhood Acute Lymphoblastic Leukemia

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

CD19-positive B-cell acute lymphoblastic leukemia

CD22 Positive B-cell Acute Lymphoblastic Leukemia

Precursor B-lymphoblastic lymphoma/leukemia refractory

Refractory B Acute Lymphoblastic Leukemia

Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia

Philadelphia chromosome-positive acute lymphoblastic leukemia in relapse

Blastic Plasmacytoid Dendritic Cell Neoplasm

Refractory Adult Acute Lymphoblastic Leukemia

Anemia, Refractory, With Excess of Blasts

Philadelphia positive acute lymphocytic leukaemia

Recurrent Adult Acute Lymphoblastic Leukemia

Aggressive-Phase Chronic Myelocytic Leukemia

Blast Phase Chronic Granulocytic Leukemia

Burkitt-like lymphoma with 11q aberration

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

Acute myeloid leukemia with multilineage dysplasia

Adult acute myeloid leukemia with del(5q)

Advanced Head and Neck Squamous Cell Carcinoma

Childhood Acute Monoblastic Leukemia and Acute Monocytic Leukemia

Childhood Central Nervous System Neoplasm

Chronic lymphocytic leukaemia refractory

Estrogen receptor positive breast cancer

Estrogen receptor-negative breast cancer

Hormone receptor negative HER2 positive breast cancer

Locally Advanced Malignant Solid Neoplasm

Metastatic Malignant Neoplasm to the Leptomeninges

Muscle Invasive Bladder Urothelial Carcinoma

Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia

progesterone receptor-negative breast cancer

Recurrent Adult Grade III Lymphomatoid Granulomatosis

Recurrent Anaplastic Large Cell Lymphoma

Recurrent Ph-Like Acute Lymphoblastic Leukemia

Recurrent Squamous Cell Carcinoma of the Head and Neck

refractory acute lymphoid leukemia in relapse

Refractory cytopenia with multilineage dysplasia and ringed sideroblasts

Refractory Ph-Like Acute Lymphoblastic Leukemia

Renal Pelvis and Ureter Urothelial Carcinoma

Secondary Central Nervous System Lymphoma

Stage II Non-Contiguous Adult Diffuse Small Cleaved Cell Lymphoma

Transitional cell cancer of the renal pelvis and ureter localised

untreated pediatric acute nonlymphocytic leukemia

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


Ibuprofen/Anhydrous Caffeine/Pseudoephedrine Hydrochloride/DL-Methylephedrine Hydrochloride/Chlorpheniramine Maleate


Aflibercept Biosimilar (Celltrion, Inc.)

Retinal vein occlusion-related macular edema

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


Lecithin Cholesterol Acyltransferase Deficiency

United States
China
European Union
Australia
Germany
Iceland
Liechtenstein
Norway
Singapore


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

Hormone receptor positive HER2 negative breast cancer

Estrogen receptor positive breast cancer

Human epidermal growth factor 2 negative carcinoma of breast

Hormone Receptor Positive Breast Adenocarcinoma

United States
European Union
United Kingdom
Iceland
Liechtenstein
Norway


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


Metastatic castration-resistant prostate cancer


4-factor prothrombin complex concentrate

Lyophilized Human Prothrombin Complex Concentrate

Vitamin K-Dependent Clotting Factors, Combined Deficiency Of, 1


Liraglutide biosimilar (Chia Tai Tianqing)

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

利拉鲁肽生物类似药（Chia Tai Tianqing Pharmaceutical Group Co., Ltd.）


Diffuse large B-cell lymphoma refractory


Glucagon-like peptide II (2-glycine) (human)

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


Recombinant humanized monoclonal antibody MIL62 (Beijing InnoCare)

AQP4-IgG positive Neuromyelitis optica spectrum disorder

Refractory Indolent Non-Hodgkin Lymphoma

CD20 Positive B-Cell Non-Hodgkin Lymphoma


COVID-19 Bivalent Vaccine(Original/Omicron BA.4-5)


Lyophilized Human Alpha1-Proteinase Inhibitor Concentrate


naltrexone implant(Drug Delivery Company)


Anti-CD20/CD3 bispecific monoclonal antibody RO7082859

T-cell/histiocyte rich large B-cell lymphoma

Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Refractory Mature B-Cell Non-Hodgkin Lymphoma

Epstein-Barr virus associated Diffuse Large B-Cell Lymphoma

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

United States
China
European Union
Canada
Australia
Iceland
Liechtenstein
Norway


Human immunodeficiency virus type 1 protease


United States
China
Japan
Brazil
South Korea


Anti-rabies monoclonal antibody cocktail


Liraglutide Biosimilar (Glenmark Pharmaceuticals Ltd.)


Heparin-induced thrombocytopenia and thrombosis

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Sodium voltage-gated channel alpha subunits


Proto-oncogene tyrosine-protein kinase ROS

Reactive oxygen species 1 positive non-small cell lung cancer

CDH1 Mutation Invasive Lobular Breast Carcinoma

Large cell neuroendocrine carcinoma of lung

Locally Advanced Malignant Solid Neoplasm


Erosive gastro-esophageal reflux disease

Non-erosive gastro-esophageal reflux disease


Idiopathic pulmonary arterial hypertension

Chronic thromboembolic pulmonary hypertension

syndrome; salt-losing, adrenogenital syndrome


Dorzolamide Hydrochloride/Timolol Maleate/Brimonidine Tartrate


Sleep Initiation and Maintenance Disorders


SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor

Somatostatin Receptor-Positive Neuroendocrine Tumor

Peptide Conjugate Radionuclide
Diagnostic radiopharmaceuticals

United States
European Union
Iceland
Liechtenstein
Norway


Chronic rhinosinusitis with nasal polyps

United States
China
European Union
Japan
United Kingdom
Iceland
Liechtenstein
Norway


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


Tocilizumab biosimilar (Taizhou Mabtech)

Tocilizumab Biosimilar (Taizhou Mabtech Pharmaceutical Co. Ltd.)

托珠单抗生物类似药（Taizhou Mabtech Pharmaceutical Co. Ltd.）


Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)

Prophylactic vaccine
Genetically engineered subunit vaccine


Ustekinumab Biosimilar (Celltrion, Inc.)


United States
Japan
Germany
Finland
Netherlands


Peginterferon Alfacon-2(Beijing Kawin Technology)

PEG Interferon (Beijing Kawin Technology)

Peginterferon SA (Beijing Kawin Technology)

Pegylated Recombinant Consensus Interferon Variant(Chongqing Fujin Biological Medicine Co Ltd)


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


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

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

China
European Union
Bolivia
Egypt
Iceland
Liechtenstein
Mexico
Norway


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


Interferon alfacon-1 (genetical recombination) (JAN)


Small molecule drug
Other diagnostic agent


Platelet-derived growth factor receptor beta

Aggressive-Phase Chronic Myelocytic 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

Estrogen receptor-negative breast cancer

Advanced Triple-Negative Breast Carcinoma

BCR-ABL Negative Atypical Chronic Myeloid Leukemia

Chronic lymphocytic leukaemia refractory

Estrogen receptor positive breast cancer

Hormone receptor positive HER2 negative breast cancer

Locally Advanced Head and Neck Squamous Cell Carcinoma

Locally Advanced Pancreatic Adenocarcinoma

Metastatic castration-resistant prostate cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia

Recurrent Squamous Cell Carcinoma of the Head and Neck

Urothelial Carcinoma of the Urinary Bladder


United States
China
European Union
Iceland
South Korea
Liechtenstein
Norway


Nepafenac ophthalmic suspension 0.1% - Alcon

United States
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Dextromethorphan Hydrobromide Hydrate/Chlorpheniramine Maleate/Ascorbic Acid/Acetaminophen


Complicated skin and soft tissue infection

Japan
Canada
Spain
Italy
South Korea
Portugal


Recombinant protein COVID-19 vaccine (WestVac Biopharma)

Recombinant SARS-CoV-2 vaccine (Sf9 cells)(Sichuan University)

Recombinant SARSCoV2 vaccine (Sf9 Cells)


Philadelphia chromosome positive chronic myelogenous leukemia

Diffuse large B-cell lymphoma refractory

Primary mediastinal large B-cell lymphoma recurrent

Primary mediastinal large B-cell lymphoma refractory

Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Chronic lymphocytic leukaemia refractory

Acute myeloid leukaemia with 11q23 abnormality

Acute Myeloid Leukemia with Myelodysplasia-Related Changes

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

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

AIDS-Related Diffuse Large Cell Lymphoma

Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma

CD19-positive B-cell acute lymphoblastic leukemia

Refractory B Acute Lymphoblastic Leukemia

Recurrent Mixed Phenotype Acute Leukemia

Refractory Mixed Phenotype Acute Leukemia

Transient Myeloproliferative Disorder of Down Syndrome

Treatment related acute myeloid leukaemia

Acute myeloid leukemia with multilineage dysplasia

Adult Acute Monoblastic and Monocytic Leukemia

Adult acute myeloid leukemia with del(5q)

BCR-ABL Negative Atypical Chronic Myeloid Leukemia

CD22 positive Acute Lymphoblastic Leukemia

Childhood Acute Monoblastic Leukemia and Acute Monocytic Leukemia

Childhood Nodular Sclerosis Classic Hodgkin Lymphoma

Human Papillomavirus-Related Cervical Carcinoma

Locally Advanced Head and Neck Squamous Cell Carcinoma

Neutropenia, Severe Congenital, Autosomal Recessive 3

pediatric lymphoblastic non-Hodgkin's lymphoma

Philadelphia positive acute lymphocytic leukaemia

Primary Cutaneous Anaplastic Large Cell Lymphoma

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

Refractory Indolent Non-Hodgkin Lymphoma

Stage II Non-Contiguous Adult Diffuse Small Cleaved Cell Lymphoma

Steroid Refractory Graft Versus Host Disease

untreated pediatric acute nonlymphocytic leukemia

China
Japan
Canada
Australia
Brazil
New Zealand


Polyarticular Juvenile Idiopathic Arthritis

Systemic onset juvenile chronic arthritis


gamma-aminobutyric acid type A receptor subunit alpha1

Obstructive Sleep Apnea Hypopnea Syndrome

United States
Denmark
Finland
Iceland
South Korea
Norway
Poland
Sweden


Tirofiban Hydrochloride and Sodium Chloride

Non ST segment elevation acute coronary syndrome


Hormone receptor positive HER2 negative breast cancer

HR Positive/HER2 Negative/Node positive breast cancer


Vascular endothelial growth factor receptor 3

Vascular endothelial growth factor receptor 2

Metastatic Triple-Negative Breast Carcinoma

PD-L1 positive Non-Small Cell Lung Cancer

Metastatic Carcinoma to the Uterine Cervix

Urothelial Carcinoma of the Urinary Bladder

Neuroendocrine neoplasm of gastrointestinal tract

Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Locally Advanced Malignant Solid Neoplasm

Metastatic Gastrointestinal Stromal Tumor

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

Unresectable Gastrointestinal Stromal Tumor


Attention Deficit and Disruptive Behavior Disorders

United States
China
Australia
Austria
Germany
Denmark
Spain
Finland
Greece
Ireland
Iceland
Italy
Norway
Portugal
Sweden


Hormone receptor negative HER2 positive breast cancer

Metastatic castration-resistant prostate cancer

Hormone Receptor Positive Breast Adenocarcinoma

Hormone receptor positive Endometrial Carcinoma

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Estrogen receptor positive breast cancer

Recurrent HER2-Negative Breast Carcinoma

Microsatellite Instability-high Solid Tumors

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

Hormone receptor positive HER2 positive breast cancer

Human epidermal growth factor 2 negative carcinoma of breast

Metastatic Pancreatic Ductal Adenocarcinoma

Metastatic Triple-Negative Breast Carcinoma

Recurrent Squamous Cell Carcinoma of the Head and Neck

Hormone receptor positive HER2 negative breast cancer

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


Calcitonin gene-related peptide type 1 receptor


Platinum-Resistant Fallopian Tube Carcinoma

Platinum-sensitive epithelial ovarian cancer

Platinum-Sensitive Fallopian Tube Carcinoma

Platinum-Sensitive Primary Peritoneal Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

Recurrent Platinum-Resistant Primary Peritoneal Carcinoma

Fallopian Tube High Grade Serous Adenocarcinoma

high grade serous adenocarcinoma of ovary

Primary Peritoneal High-Grade Serous Adenocarcinoma

Microsatellite instability-high colorectal cancer

Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

Neck Squamous Cell Carcinoma of Unknown Primary

Relapsed Squamous Cell Carcinoma of the Larynx

Squamous cell carcinoma of head and neck metastatic

Squamous cell carcinoma of the hypopharynx

Squamous cell carcinoma of the oral cavity recurrent

Squamous Cell Carcinoma of the Oropharynx

Primary Peritoneal Transitional Cell Carcinoma

Fallopian Tube Clear Cell Adenocarcinoma

Primary Peritoneal Serous Adenocarcinoma

Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck

Recurrent Pharyngeal Squamous Cell Carcinoma

Recurrent Squamous Cell Carcinoma of the Head and Neck

Recurrent Ovarian Clear Cell Adenocarcinoma

Recurrent Ovarian Undifferentiated Carcinoma

Recurrent Platinum-Resistant Fallopian Tube Carcinoma

Recurrent Primary Peritoneal Clear Cell Adenocarcinoma

Recurrent Primary Peritoneal Endometrioid Adenocarcinoma

Secondary malignant neoplasm of peritoneum

Recurrent Triple-Negative Breast Carcinoma

Metastatic Microsatellite Stable Colorectal Carcinoma

Microsatellite Stable Colorectal Carcinoma

Locally Advanced Hepatocellular Carcinoma

Refractory Primary Peritoneal Serous Adenocarcinoma

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

thyroid gland poorly differentiated carcinoma

Human Papillomavirus-Related Anal Squamous Cell Carcinoma

Human Papillomavirus-Related Cervical Squamous Cell Carcinoma

Human Papillomavirus-Related Squamous Cell Carcinoma of the Penis

Human Papillomavirus-Related Vulvar Squamous Cell Carcinoma

EGFR positive non-small cell lung cancer

Recurrent Anaplastic (Malignant) Meningioma

HER2 Positive Gastroesophageal Adenocarcinoma

Metastatic HER2 positive gastroesophageal junction cancer

Hereditary Leiomyomatosis and Renal Cell Cancer

Papillary Renal Cell Carcinoma, Sporadic

Hormone receptor positive HER2 negative breast cancer

Metastatic Clear Cell Renal Cell Carcinoma

Metastatic castration-resistant prostate cancer

Locally Advanced Lung Non-Small Cell Carcinoma

Platinum-Resistant Epithelial Ovarian Carcinoma

Adult Acute Monoblastic and Monocytic Leukemia

Advanced Lung Non-Small Cell Squamous Carcinoma

Advanced Pancreatic Ductal Adenocarcinoma

Advanced Pancreatic Neuroendocrine Tumor

Advanced Triple-Negative Breast Carcinoma

Blast Phase Chronic Granulocytic Leukemia

Breast Carcinoma Metastatic in the Brain

CD20 positive Diffuse Large B-Cell Lymphoma

Childhood Acute Monoblastic Leukemia and Acute Monocytic Leukemia

Childhood Central Nervous System Neoplasm

childhood malignant fibrous histiocytoma of bone

Childhood Nodular Sclerosis Classic Hodgkin Lymphoma

Chronic lymphocytic leukaemia refractory

Early-Onset Ataxia With Oculomotor Apraxia and Hypoalbuminemia

EGFR positive Non-squamous non-small cell lung cancer

Estrogen receptor positive breast cancer

Estrogen receptor-negative breast cancer

Hormone Receptor Positive Breast Adenocarcinoma

Human epidermal growth factor 2 negative carcinoma of breast

Locally Advanced Clear Cell Renal Cell Carcinoma

Locally Advanced Esophageal Squamous Cell Carcinoma

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Locally Advanced Head and Neck Squamous Cell Carcinoma

Locally Advanced Malignant Solid Neoplasm

Locally Advanced Pancreatic Adenocarcinoma

Locally Advanced Unresectable Gastric Adenocarcinoma

Metastatic Carcinoma to the Uterine Cervix

Metastatic Digestive System Neuroendocrine Tumor G1

Metastatic Esophageal Squamous Cell Carcinoma

Metastatic Gastroesophageal Junction Adenocarcinoma

Metastatic HER2-Negative Breast Carcinoma

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Metastatic Malignant Neoplasm to the Leptomeninges

Metastatic Triple-Negative Breast Carcinoma

Metastatic Urethral Urothelial Carcinoma

Nasopharyngeal Keratinizing Squamous Cell Carcinoma

Pancreatic neuroendocrine tumour metastatic

pediatric lymphoblastic non-Hodgkin's lymphoma

Peripheral Primitive Neuroectodermal Tumors

Philadelphia chromosome positive chronic myelogenous leukemia

Primary Cutaneous Anaplastic Large Cell Lymphoma

progesterone receptor-negative breast cancer

Recurrent Anaplastic Large Cell Lymphoma

Recurrent HER2-Negative Breast Carcinoma

recurrent lymphoepithelioma of the oropharynx

recurrent metastatic squamous neck cancer with occult primary

recurrent primary peritoneal cavity cancer

Relapsed Oral Cavity Mucoepidermoid Carcinoma

Relapsed Undifferentiated Carcinoma of the Nasopharynx

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

Undifferentiated carcinoma of nasopharynx

Unresectable Gastrointestinal Stromal Tumor

Unresectable Lung Non-Small Cell Carcinoma

Unresectable Pleural Malignant Mesothelioma

untreated pediatric acute nonlymphocytic leukemia

Well Differentiated Pancreatic Endocrine Tumor

United States
China
European Union
Japan
Iceland
Liechtenstein
Norway


Aflibercept Biosimilar (Sandoz International GmbH)

Retinal vein occlusion-related macular edema

United States
European Union
Canada
Australia
Iceland
Liechtenstein
Norway


Deoxyribonuclease (human clone 18-1 protein moiety)

Dornase alfa (genetical recombination) (JAN)


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


Thrombotic Thrombocytopenic Purpura, Acquired

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


Recombinant human thyroid stimulating hormone

Thyrotropin Alfa (Genetical Recombination)

Thyrotropin alfa (genetical recombination) (JAN)

Thyrotropin human alfa (genetical recombination)

United States
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Beclometasone Dipropionate/Formoterol fumarate Dihydrate/Glycopyrronium Bromide

Beclometasone Dipropionate Anhydrous/Formoterol Fumarate Dihydrate/Glycopyrronium

Beclometasone dipropionate anhydrous/formoterol fumarate dihydrate/glycopyrronium bromide

Beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium

China
European Union
Canada
Iceland
Liechtenstein
Norway


Dual specificity mitogen-activated protein kinase kinase 1

Dual specificity mitogen-activated protein kinase kinase 2

Refractory Langerhans Cell Histiocytosis

Resectable Lung Non-Small Cell Carcinoma

Locally Advanced Pancreatic Adenocarcinoma

BRAF V600E Mutation-Positive Solid Tumors

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

Estrogen receptor positive breast cancer

Locally Advanced Malignant Solid Neoplasm

Metastatic Triple-Negative Breast Carcinoma

Microsatellite instability-high colorectal cancer

Squamous Cell Carcinoma of Head and Neck


United States
European Union
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Ustekinumab Biosimilar (Cipla Australia Pty Ltd.)


United States
China
Japan
United Kingdom
Australia
India
Costa Rica
South Korea
Singapore


Japan
United Kingdom
Canada
Australia
United Arab Emirates
Bahrain
Brazil
Switzerland
Egypt
Italy
Kuwait
Oman
Qatar
Saudi Arabia
Singapore
Thailand


Hepatitis C virus NS5B RNA-dependent RNA polymerase

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

Advanced Head and Neck Squamous Cell Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Recurrent Platinum-Resistant Primary Peritoneal Carcinoma


Insulin Aspart (Genetical Recombination)


LSAM-Cisplatin  for Sterile Suspension(NanOlogy)

Squamous cell carcinoma of the oral cavity

Locally Advanced Head and Neck Squamous Cell Carcinoma

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

Unresectable Pleural Malignant Mesothelioma

Metastatic Pancreatic Ductal Adenocarcinoma

Resectable Lung Non-Small Cell Carcinoma

Urothelial Carcinoma of the Urinary Bladder

Recurrent Squamous Cell Carcinoma of the Head and Neck

Squamous cell carcinoma of head and neck metastatic

Recurrent Anaplastic Large Cell Lymphoma

Metastatic Triple-Negative Breast Carcinoma

Non-Muscle Invasive Bladder Urothelial Carcinoma

Locally Advanced Malignant Solid Neoplasm

Advanced Triple-Negative Breast Carcinoma

EGFR positive Non-squamous non-small cell lung cancer

HPV positive oropharyngeal squamous cell carcinoma

Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Locally Advanced Unresectable Gastric Adenocarcinoma

Malignant neoplasm of gastro-oesophageal junction

Metastatic Gastroesophageal Junction Adenocarcinoma

Metastatic HER2 positive gastroesophageal junction cancer

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Neuroendocrine neoplasm of gastrointestinal tract

Platinum-Resistant Primary Peritoneal Carcinoma

Recurrent Gastroesophageal Junction Adenocarcinoma

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

Squamous cell carcinoma of the hypopharynx

Squamous Cell Carcinoma of the Oropharynx

thyroid gland poorly differentiated carcinoma

Transitional cell cancer of renal pelvis and ureter metastatic

Unresectable Lung Non-Small Cell Carcinoma


Polyarticular Juvenile Idiopathic Arthritis

United States
European Union
Canada
Australia
Switzerland
Egypt
Iceland
Liechtenstein
Norway
Saudi Arabia


4-(butylamino)benzoic acid 3,6,9,12,15,18,21,24,27-nonaoxaoctacos-1-yl ester

nonaethyleneglycol monomethyl ether p-n-butylaminobenzoate

p-butylaminobenzoic acid ω-O-methylnonaethyleneglycol ester

Sodium voltage-gated channel alpha subunits


Anemia, Refractory, With Excess of Blasts

Chronic lymphocytic leukaemia refractory

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


Pegfilgrastim  Biosimilar (Mochida Pharmaceutical Co., Ltd.)

培非格司亭生物类似药（Mochida Pharmaceutical Co., Ltd.）


EMAP Like 4-Anaplastic lymphoma kinase fusion

Proto-oncogene tyrosine-protein kinase ROS

ALK-Positive Inflammatory Myofibroblastic Tumor

ALK-positive anaplastic large cell lymphoma

Reactive oxygen species 1 positive non-small cell lung cancer

c-Met positive non-small cell lung cancer

Locally Advanced Clear Cell Renal Cell Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Metastatic castration-resistant prostate cancer

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Recurrent Anaplastic Large Cell Lymphoma

Refractory Systemic Anaplastic Large Cell Lymphoma

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


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


Fallopian Tube Clear Cell Adenocarcinoma

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

Locally Advanced Malignant Solid Neoplasm

Squamous Cell Carcinoma of Head and Neck

Hormone receptor positive HER2 negative breast cancer

PIK3CA mutated/HER2 Positive Breast Cancer


阿法达贝泊汀生物类似药(JCR Pharmaceuticals Co., Ltd.)

Darbepoetin alfa biosimilar(JCR Pharmaceuticals Co., Ltd.)

ダルベポエチン アルファ（遺伝子組換え）(JCR Pharmaceuticals)


ペルツズマブ（遺伝子組換え）/トラスツズマブ（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）

pertuzumab plus trastuzumab plus hyaluronidase-zzxf

Metastatic human epidermal growth factor 2 positive carcinoma of breast

United States
China
European Union
Japan
Canada
Iceland
Liechtenstein
Norway


Sleep Initiation and Maintenance Disorders


Clostridium Botulinum Toxin Type A (ATGC)


Attention Deficit Disorder With Hyperactivity


5-hydroxytryptamine receptors, ionotropic (HTR3)

Chemotherapy-induced nausea and vomiting


United States
China
European Union
Australia
Iceland
South Korea
Liechtenstein
Norway


Dabigatran etexilate methanesulfonate (JAN)

Metabolic dysfunction-associated steatotic liver disease


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

Locally Advanced Lung Non-Small Cell Carcinoma

EGFR positive non-small cell lung cancer

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


European Union
Iceland
Liechtenstein
Norway


Corticosteroid 11-beta-dehydrogenase isozyme 1

Glutamate [NMDA] receptor subunit epsilon 2


United States
European Union
Japan
Iceland
Liechtenstein
Norway


Philadelphia chromosome positive chronic myelogenous leukemia


European Union
Australia
Brazil
France
Iceland
Liechtenstein
Norway


Diffuse midline glioma, point mutation K27M in histone H3

Advanced Gastroesophageal Junction Adenocarcinoma

Advanced Triple-Negative Breast Carcinoma

Aggressive-Phase Chronic Myelocytic Leukemia

Metastatic castration-resistant prostate cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Metastatic Triple-Negative Breast Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

Steroid Refractory Graft Versus Host Disease

United States
China
European Union
Canada
Australia
Iceland
Liechtenstein
Norway


Ozagrel Trometamol Concentrated Solution


Ustekinumab biosimilar (Accord BioPharma)

United States
European Union
Iceland
Liechtenstein
Norway


Microsatellite Instability-high Solid Tumors

Microsatellite instability-high colorectal cancer

Locally Advanced Malignant Solid Neoplasm


Recombinant human insulin (YiChang HEC ChangJiang Pharma)


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


Sodium voltage-gated channel alpha subunits


Anti-interleukin-12 p40 monoclonal antibody

Ustekinumab (genetical recombination) (JAN)


mRNA encoding haemagglutinin of B/Victoria lineage, haemagglutinin of influenza A/H1N1, haemagglutinin of influenza A/H3N2, SARS-CoV-2 spike protein NTD-RBD subdomains

Influenza virus hemagglutinin glycoproteins


CD20 positive Diffuse Large B-Cell Lymphoma

CD20 Positive B-Cell Non-Hodgkin Lymphoma


MRSA - Methicillin resistant Staphylococcus aureus infection


Hormone receptor positive HER2 negative breast cancer

HR Positive/HER2 Negative/Node positive breast cancer

Metastatic castration-resistant prostate cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Hormone receptor positive HER2 positive breast cancer

Estrogen receptor positive breast cancer


Antihemophilic factor (recombinant), glycopegylated-exei

Recombinant Human Coagulation Factor VIII (Novo Nordisk)

Turoctocog Alfa Pegol (Genetical Recombination)

United States
China
European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


Olipudase Alfa (Genetical Recombination)

Olipudase alfa (genetical recombination) (JAN)

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


Sodium zirconium cyclosilicate hydrate (JAN)

Heart failure with reduced ejection fraction

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


antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl

Fc fusion protein
Recombinant coagulation factor
XTEN fusion protein

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


Polyarticular Juvenile Idiopathic Arthritis

United States
European Union
Canada
Australia
Iceland
Liechtenstein
Norway


Immune Reconstitution Inflammatory Syndrome


Protein kinase AMP-activated non-catalytic subunit beta 1


4-amino-2-chlorobenzoic acid 2-(diethylamino)ethyl ester

United States
China
Canada
Austria
Belgium
Germany
Spain
France
Ireland
Italy
Poland


KRAS G12C mutant Non-small Cell Lung Cancer

Locally Advanced Lung Non-Small Cell Carcinoma


Diffuse large B-cell lymphoma refractory

Extramedullary Disease in Multiple Myeloma

Recurrent Central Nervous System Lymphoma

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

Refractory Acute Leukemia of Ambiguous Lineage

T-cell/histiocyte rich large B-cell lymphoma

Childhood Central Nervous System Neoplasm

Refractory Central Nervous System Lymphoma

Blast Phase Chronic Granulocytic Leukemia

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Childhood Acute Lymphoblastic Leukemia

Recurrent Mixed Phenotype Acute Leukemia

Refractory B Acute Lymphoblastic Leukemia

Refractory Mixed Phenotype Acute Leukemia

Acute Myeloid Leukemia with FLT3/ITD Mutation

Adult acute myeloid leukemia with del(5q)

Advanced Head and Neck Squamous Cell Carcinoma

Anemia, Refractory, With Excess of Blasts

Chronic lymphocytic leukaemia refractory

Metastatic castration-resistant prostate cancer

Metastatic Triple-Negative Breast Carcinoma

Refractory Indolent Non-Hodgkin Lymphoma

Squamous Cell Carcinoma of Head and Neck

Treatment related acute myeloid leukaemia

Unresectable Lung Non-Small Cell Carcinoma

United States
China
European Union
United Kingdom
Canada
Australia
Hong Kong
Indonesia
Israel
Iceland
South Korea
Liechtenstein
Macao
Malaysia
Norway
Singapore
Thailand
Taiwan Province


Bis(2-chloroethyl)phosphoramide cyclic propanolamide ester

Philadelphia chromosome positive chronic myelogenous leukemia

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

Peripheral Primitive Neuroectodermal Tumors

pediatric lymphoblastic non-Hodgkin's lymphoma

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

CD19-positive B-cell acute lymphoblastic leukemia

Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia

CD-30 positive Peripheral T-Cell Lymphoma

Primary mediastinal large B-cell lymphoma recurrent

Primary mediastinal large B-cell lymphoma refractory

Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Extramedullary Disease in Multiple Myeloma

Diffuse large B-cell lymphoma refractory

Platinum-Resistant Fallopian Tube Carcinoma

Platinum-Sensitive Fallopian Tube Carcinoma

CD22 Positive B-cell Acute Lymphoblastic Leukemia

Precursor B-lymphoblastic lymphoma/leukemia refractory

Recurrent B Acute Lymphoblastic Leukemia

Refractory B Acute Lymphoblastic Leukemia

ALK-positive anaplastic large cell lymphoma

Acute myeloid leukaemia with 11q23 abnormality

Acute Myeloid Leukemia with Myelodysplasia-Related Changes

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

Blastic Plasmacytoid Dendritic Cell Neoplasm

Refractory Acute Undifferentiated Leukemia

Refractory Adult Acute Lymphoblastic Leukemia

Adult acute myeloid leukemia with del(5q)

Advanced Triple-Negative Breast Carcinoma

Blast Phase Chronic Granulocytic Leukemia

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Recurrent Adult Acute Lymphoblastic Leukemia

Anemia, Refractory, With Excess of Blasts

Childhood Nodular Sclerosis Classic Hodgkin Lymphoma

Aggressive-Phase Chronic Myelocytic Leukemia

Recurrent Childhood Acute Lymphoblastic Leukemia

Recurrent Transformed B-Cell Non-Hodgkin Lymphoma

Hepatitis B Virus-Related Hepatocellular Carcinoma

Stage II Non-Contiguous Adult Diffuse Small Cleaved Cell Lymphoma

Burkitt-like lymphoma with 11q aberration

Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma

Recurrent Transformed Chronic Lymphocytic Leukemia

Refractory Transformed Chronic Lymphocytic Leukemia

Metastatic castration-resistant prostate cancer

Epstein-Barr virus associated Diffuse Large B-Cell Lymphoma

T-cell/histiocyte rich large B-cell lymphoma

Recurrent Platinum-Resistant Fallopian Tube Carcinoma

Peripheral T-cell lymphoma unspecified refractory

Recurrent Anaplastic Large Cell Lymphoma

Refractory Systemic Anaplastic Large Cell Lymphoma

AIDS-Related Diffuse Large Cell Lymphoma

Fallopian Tube High Grade Serous Adenocarcinoma

Locally Advanced Unresectable Breast Carcinoma

Acute myeloid leukemia with multilineage dysplasia

Advanced Gastroesophageal Junction Adenocarcinoma

BCR-ABL Negative Atypical Chronic Myeloid Leukemia

CD20 positive Diffuse Large B-Cell Lymphoma

Chemotherapy-induced nausea and vomiting

Childhood Acute Monoblastic Leukemia and Acute Monocytic Leukemia

Childhood Central Nervous System Neoplasm

Crouzon Syndrome With Acanthosis Nigricans

Estrogen receptor positive breast cancer

Estrogen receptor-negative breast cancer

GRPR Positive/ER Positive/HER2 Negative Breast Cancer

high grade serous adenocarcinoma of ovary

Hormone receptor negative HER2 positive breast cancer

Hormone receptor positive HER2 positive breast cancer

HR Positive/HER2 Negative/Node positive breast cancer

Human epidermal growth factor 2 negative carcinoma of breast

Locally Advanced Malignant Solid Neoplasm

Metastatic Digestive System Neuroendocrine Tumor G1

Metastatic Gastroesophageal Junction Adenocarcinoma

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Metastatic Pancreatic Ductal Adenocarcinoma

Metastatic Triple-Negative Breast Carcinoma

Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia

Philadelphia positive acute lymphocytic leukaemia

Platinum-Resistant Epithelial Ovarian Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma

Primary Cutaneous Anaplastic Large Cell Lymphoma

progesterone receptor-negative breast cancer

Recurrent Adult Grade III Lymphomatoid Granulomatosis

Recurrent Aggressive Non-Hodgkin Lymphoma

Recurrent Gastroesophageal Junction Adenocarcinoma

Recurrent High Grade Fallopian Tube Serous Adenocarcinoma

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

Recurrent Ph-Like Acute Lymphoblastic Leukemia

Recurrent Platinum-Resistant Ovarian Carcinoma

Refractory cytopenia with multilineage dysplasia and ringed sideroblasts

Refractory Indolent Non-Hodgkin Lymphoma

Refractory Ph-Like Acute Lymphoblastic Leukemia

Refractory Primary Peritoneal Serous Adenocarcinoma

Steroid Refractory Graft Versus Host Disease

T-cell acute lymphoblastic leukemia in relapse

Treatment related acute myeloid leukaemia

untreated pediatric acute nonlymphocytic leukemia


L-Valine ester with 9-((2-hydroxyethoxy)methyl)guanine

Resectable Lung Non-Small Cell Carcinoma


Human Prothrombin Complex (Lanzhou Lansheng Blood Products)


Adalimumab biosimilar(Innovent Biologics (Suzhou) Co. Ltd.)

Polyarticular Juvenile Idiopathic Arthritis


Persistent Polyclonal B-Cell Lymphocytosis


Asparaginase Erwinia Chrysanthemi (Recombinant)

Asparaginase Erwinia Chrysanthemi(Jazz Pharmaceuticals)

Asparaginase Erwinia chrysanthemi (recombinant)-rywn

Recombinant Asparginase Erwinia chrysanthemi - Jazz Pharmaceuticals/Pfenex

Recombinant Erwinia asparaginase - Jazz Pharmaceuticals/Pfenex

asparaginase Erwinia chrysanthemi(Jazz Pharmaceuticals Plc)

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia

Blast Phase Chronic Granulocytic Leukemia


Antihemophilic Factor (Recombinant), PEGylated

Rurioctocog Alfa Pegol (Genetical Recombination)

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


N-[(3E)-1-oxo-3-hexenyl]Somatoliberin (human pancreatic islet)


Infliximab biosimilar(Shanghai Biomabs Pharmaceuticals Co., Ltd.)

Infliximab Biosimilar (Shanghai Biomabs Pharmaceuticals Co., Ltd.)

英夫利西单抗生物类似药（Shanghai Biomabs Pharmaceuticals Co., Ltd.）


United States
European Union
United Kingdom
Canada
Iceland
Liechtenstein
Norway


United States
European Union
United Kingdom
Iceland
Liechtenstein
Norway


Tumor-associated calcium signal transducer 2

Hormone receptor positive HER2 negative breast cancer

EGFR positive Non-squamous non-small cell lung cancer

Mismatch repair-deficient Endometrial Carcinoma

Platinum-sensitive epithelial ovarian cancer

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Metastatic Carcinoma to the Uterine Cervix

Locally Advanced Lung Non-Small Cell Carcinoma

Resectable Lung Non-Small Cell Carcinoma

PD-L1 negative Triple Negative Breast Cancer

PD-L1 positive Triple Negative Breast Cancer

PD-L1 positive Non-Small Cell Lung Cancer

Unresectable Esophageal Squamous Cell Carcinoma

Metastatic Triple-Negative Breast Carcinoma

Advanced Gastroesophageal Junction Adenocarcinoma

Metastatic castration-resistant prostate cancer

Prostate Adenocarcinoma with Neuroendocrine Differentiation

Oesophageal squamous cell carcinoma recurrent

EGFR positive non-small cell lung cancer

Locally Advanced Malignant Solid Neoplasm

Squamous Cell Carcinoma of Head and Neck

Urothelial Carcinoma of the Urinary Bladder


Recombinant coagulation factor VIII(Chia Tai-Tianqing)


Nystatin/Neomycin Sulphate/Polymyxin B Sulphate

nystatin/neomycin sulphate/polymyxin B sulphate


Bevacizumab biosimilar(Shanghai Institute of Biological Products)

Bevacizumab Biosimilar (Shanghai Institute of Biological Products Co., Ltd.)

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma


pediatric lymphoblastic non-Hodgkin's lymphoma

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Childhood Acute Lymphoblastic Leukemia

Advanced Triple-Negative Breast Carcinoma

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Refractory Adult Acute Lymphoblastic Leukemia

Treatment related acute myeloid leukaemia


China
European Union
Australia
Iceland
Liechtenstein
Norway


Proliferative retinopathy with diabetes mellitus

Retinal vein occlusion-related macular edema

Best Vitelliform Macular Dystrophy, Multifocal

Central retinal vein occlusion - ischemic

Idiopathic Juxtafoveal Retinal Telangiectasia

idiopathic macular telangiectasia type 2


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


Human fibrinogen(Shanghai Institute of Biological Products Co., Ltd.)


Dual specificity mitogen-activated protein kinase kinase 1

Dual specificity mitogen-activated protein kinase kinase 2

BRAF V600E mutant Non-small Cell Lung Cancer

BRAF Mutation Non-small Cell Lung Cancer


Recurrent major depressive disorder with atypical features

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


Renal Pelvis and Ureter Urothelial Carcinoma

Urothelial Carcinoma of the Urinary Bladder


Ibritumomab tiuxetan (genetical recombination) (JAN)

mAb Murine (IGG1) Anti P19437 (CD20_MOUSE)

Refractory Aggressive Non-Hodgkin Lymphoma

CD20 Positive B-Cell Non-Hodgkin Lymphoma

CD20 positive Diffuse Large B-Cell Lymphoma

CD30-positive diffuse large B-cell lymphoma

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

Recurrent Transformed B-Cell Non-Hodgkin Lymphoma

Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma

Radiolabeled antibody
Therapeutic radiopharmaceuticals

United States
European Union
Japan
Hong Kong
Iceland
Liechtenstein
Norway


Human prothrombin complex (Chengdu Rongsheng)


Collagenase Clostridium histolyticum(Biospecifics Technologies Corp)

Collagenase Clostridium histolyticum (Endo/SOBI/Asahi Kasei)


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


Human C1-inhibitor (recombinant, rabbit derived)

Recombinant complement C1 esterase inhibitor

Recombinant human C1-inhibitor rabbit milk derived

United States
European Union
Iceland
South Korea
Liechtenstein
Norway


Metabolic Dysfunction Associated Steatohepatitis

European Union
Canada
Australia
Iceland
Liechtenstein
Norway


Cystic fibrosis transmembrane conductance regulator

United States
European Union
Canada
Australia
Switzerland
Iceland
Liechtenstein
Norway


Philadelphia chromosome positive chronic myelogenous leukemia


Ventricular Fibrillation, Paroxysmal Familial, 1

China
European Union
Iceland
Liechtenstein
Norway


RET fusion-positive Non-Small Cell Lung Cancer

RET Mutation-Positive Medullary Thyroid Cancer

RET fusion-positive  Adenocarcinoma of Lung

Locally Advanced Malignant Solid Neoplasm

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


Hormone receptor positive HER2 negative breast cancer

Human Papillomavirus-Related Squamous Cell Carcinoma

Squamous Cell Carcinoma of Head and Neck

Squamous cell carcinoma of head and neck metastatic

HR Positive/HER2 Negative/Node positive breast cancer

Estrogen receptor positive breast cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Metastatic HER2-Negative Breast Carcinoma

Refractory Langerhans Cell Histiocytosis

Metastatic castration-resistant prostate cancer

Hormone receptor negative HER2 positive breast cancer

Advanced Triple-Negative Breast Carcinoma

Refractory Adult Acute Lymphoblastic Leukemia

Acute myeloid leukaemia with 11q23 abnormality

Breast Carcinoma Metastatic in the Brain

Hormone Receptor Positive Breast Adenocarcinoma

Hormone receptor positive HER2 positive breast cancer

Hormone receptor positive malignant neoplasm of breast

Human epidermal growth factor 2 negative carcinoma of breast

Metastatic Clear Cell Renal Cell Carcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent B Acute Lymphoblastic Leukemia

Recurrent Childhood Acute Lymphoblastic Leukemia

Refractory B Acute Lymphoblastic Leukemia

Refractory T Acute Lymphoblastic Leukemia

Squamous Cell Carcinoma of the Oropharynx

T-cell acute lymphoblastic leukemia in relapse

United States
China
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Anti-CD3 anti-CD20 bispecific antibody(Genmab A/S)

Diffuse large B-cell lymphoma refractory

CD20 positive Diffuse Large B-Cell Lymphoma

T-cell/histiocyte rich large B-cell lymphoma

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

Recurrent Transformed B-Cell Non-Hodgkin Lymphoma

Epstein-Barr virus associated Diffuse Large B-Cell Lymphoma

Primary mediastinal large B-cell lymphoma recurrent

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

Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma

EBV-Related Post-Transplant Lymphoproliferative Disorder


Proprotein convertase subtilisin kexin type 9

Hypercholesterolemia, Autosomal Dominant, 3


Ixekizumab (genetical recombination) (JAN)

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


United States
Japan
United Kingdom
Australia
Austria
Belgium
Cyprus
Czechia
Germany
Denmark
Spain
Greece
Croatia
Ireland
Italy
Luxembourg
Netherlands
Norway
Poland
Portugal
Sweden
Slovenia
Slovakia


cytochrome P450 family 3 subfamily A member 5

cytochrome P450 family 3 subfamily A member 7

European Union
Australia
Iceland
Liechtenstein
Norway


Factor VIII(Shanxi Kangbao Biological Products)


United States
European Union
Canada
Australia
Iceland
South Korea
Liechtenstein
Norway


Chronic lymphocytic leukaemia refractory


Austria Belgium Germany Spain Greece Italy Luxembourg Portugal


Sodium Oxybate/Potassium Oxybate/Calcium Oxybate/Magnesium Oxybate


United States
China
Japan
United Kingdom
Australia
Austria
Belgium
Germany
Finland
France
Ireland
Italy
Luxembourg
Malta
Netherlands
Sweden


Cetuximab Sarotalocan Sodium (Genetical Recombination)

Recurrent Squamous Cell Carcinoma of the Head and Neck

Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck

Squamous cell carcinoma of head and neck metastatic


Sodium voltage-gated channel alpha subunits


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


Microsatellite instability-high colorectal cancer

Squamous Cell Carcinoma of Head and Neck


WAS transduced autologous CD34+ stem cells

autologous CD34+ haematopoietic stem cells transduced ex vivo with a lentiviral vector encoding human Wiskott-Aldrich syndrome protein

Gene therapy
Hematopoietic stem cell therapy

United States
European Union
Iceland
Liechtenstein
Norway


Anti-CD19 CAR-T cell therapy (Heyuan Biotech)

Anti-CD19 Chimeric Antigen Receptor T-Cell Injection (Juventas Cell)

Refractory B Acute Lymphoblastic Leukemia

Recurrent B Acute Lymphoblastic Leukemia

CD19-positive B-cell acute lymphoblastic leukemia

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

CD19 positive Acute Lymphoblastic Leukemia

Refractory Adult Acute Lymphoblastic Leukemia

Chronic lymphocytic leukaemia refractory

Philadelphia positive acute lymphocytic leukaemia


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

United States
European Union
Japan
Australia
Iceland
South Korea
Liechtenstein
Norway


Vascular endothelial growth factor receptor 2

Germline BRCA-mutated, HER2-negative metastatic breast cancer

Metastatic HER2-Negative Breast Carcinoma

Resectable Lung Non-Small Cell Carcinoma

Cirrhosis, Familial, With Pulmonary Hypertension

Recurrent Squamous Cell Carcinoma of the Head and Neck

Hormone receptor positive HER2 negative breast cancer

EGFR positive non-small cell lung cancer

Advanced Head and Neck Squamous Cell Carcinoma

Advanced Triple-Negative Breast Carcinoma

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

Locally Advanced Esophageal Squamous Cell Carcinoma

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Malignant neoplasm of gastro-oesophageal junction

Metastatic castration-resistant prostate cancer

Metastatic Triple-Negative Breast Carcinoma

PD-L1 positive Non-Small Cell Lung Cancer

Squamous cell carcinoma of head and neck metastatic


Monoclonal T cell receptor anti-CD3 scFv fusion protein

Bispecific T-cell Engager (BiTE)
TCR fusion protein

United States
European Union
United Kingdom
Canada
Australia
Iceland
Liechtenstein
Norway


Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Recurrent Childhood Acute Lymphoblastic Leukemia

Refractory B Acute Lymphoblastic Leukemia


Omalizumab biosimilar (Generium Pharmaceuticals)


Insulin Aspart Biosimilar (YiChang HEC ChangJiang Pharmaceutical )


Sleep Initiation and Maintenance Disorders

United States
China
Japan
Canada
Australia
India
Hong Kong
Malaysia
Taiwan Province


Insulin aspart Biosimilar (Biocon Biologics, Inc.)

United States
European Union
Canada
Iceland
Liechtenstein
Norway


Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia

Aggressive-Phase Chronic Myelocytic Leukemia

Anemia, Refractory, With Excess of Blasts

CD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma

Diffuse large B-cell lymphoma refractory

Estrogen receptor positive breast cancer

Metastatic castration-resistant prostate cancer

Metastatic Clear Cell Renal Cell Carcinoma

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Metastatic Triple-Negative Breast Carcinoma

Nodular Sclerosis Classical Hodgkin Lymphoma

Philadelphia chromosome positive chronic myelogenous leukemia

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Anaplastic (Malignant) Meningioma

Recurrent Anaplastic Large Cell Lymphoma

Refractory Differentiated Thyroid Gland Carcinoma

European Union
Japan
Iceland
Liechtenstein
Norway


Human immunodeficiency virus type 1 Pol protein

Human Papillomavirus-Related Cervical Carcinoma


FGFR2 fusion or rearranged Cholangiocarcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

FGFR2 positive Intrahepatic Cholangiocarcinoma

United States
European Union
Japan
Australia
Iceland
Liechtenstein
Norway


Proto-oncogene tyrosine-protein kinase ROS

Reactive oxygen species 1 positive non-small cell lung cancer

ALK-positive anaplastic large cell lymphoma


Pulmonary arterial hypertension associated with connective tissue disease

Idiopathic pulmonary arterial hypertension

Chronic thromboembolic pulmonary hypertension


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


Sodium voltage-gated channel alpha subunits


Attention Deficit Disorder With Hyperactivity


Anti-Gd2 igg3 monoclonal antibody 3F8 humanized

Anti-Gd2 monoclonal antibody 3F8 humanized

Humanised anti-GD2 3F8 monoclonal antibody

Humanized anti-Gd2 monoclonal antibody 3F8

Humanized monoclonal antibody HU3F8-IGG1

Metastatic Triple-Negative Breast Carcinoma


Multiple Sclerosis, Secondary Progressive

Refractory Central Nervous System Lymphoma

Secondary Central Nervous System Lymphoma

Recurrent Central Nervous System Lymphoma

AQP4-IgG positive Neuromyelitis optica spectrum disorder


Modified bone marrow derived mesenchymal stem cells - SanBio


Metabolic Dysfunction Associated Steatohepatitis


Idiopathic pulmonary arterial hypertension

Associated Pulmonary Arterial Hypertension

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


Metastatic castration-resistant prostate cancer

Prostate Adenocarcinoma with Neuroendocrine Differentiation

Congenital Adrenal Hyperplasia Due to 21 Hydroxylase Deficiency

Estrogen receptor positive breast cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Mineralocorticoid Excess Syndrome, Apparent

United States
China
European Union
Japan
Australia
Brazil
Iceland
Liechtenstein
Norway


Hormone receptor positive HER2 negative breast cancer

KRAS-mutated low-grade serous ovarian cancer

Neuroendocrine neoplasm of gastrointestinal tract

Locally Advanced Malignant Solid Neoplasm

KRAS G12C mutant Non-small Cell Lung Cancer

Microsatellite instability-high colorectal cancer

Squamous Cell Carcinoma of Head and Neck

Urothelial Carcinoma of the Urinary Bladder


Mismatch repair-deficient Colonic Cancer

EGFR positive Non-squamous non-small cell lung cancer

EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma

Resectable Lung Non-Small Cell Carcinoma

Locally Advanced Esophageal Squamous Cell Carcinoma

HPV positive oropharyngeal squamous cell carcinoma

Diffuse large B-cell lymphoma refractory

Locally Advanced Lung Non-Small Cell Carcinoma

Metastatic Carcinoma to the Uterine Cervix

Locally Advanced Hepatocellular Carcinoma

Unresectable Esophageal Squamous Cell Carcinoma

Advanced Lung Non-Small Cell Squamous Carcinoma

CEACAM5 positive non-squamous non-small cell lung cancer

Epstein-Barr virus associated gastric carcinoma

Locally Advanced Gastroesophageal Junction Adenocarcinoma

Locally Advanced Unresectable Gastric Adenocarcinoma

Metastatic Esophageal Squamous Cell Carcinoma

Metastatic Gastroesophageal Junction Adenocarcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Microsatellite instability-high colorectal cancer

PD-L1 positive Non-Small Cell Lung Cancer

Unresectable Lung Non-Small Cell Carcinoma


Proliferative retinopathy with diabetes mellitus

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


Oxymetazoline Hydrochloride/Chlorpheniramine Maleate/Glycyrrhizinate dipotassium

Corticosteroid 11-beta-dehydrogenase isozyme 1


Platelet-derived growth factor receptor alpha

Vascular endothelial growth factor receptor 1

Vascular endothelial growth factor receptor 2

Vascular endothelial growth factor receptor 3

Squamous Cell Carcinoma of Head and Neck

Urothelial Carcinoma of the Urinary Bladder

Unresectable Pleural Malignant Mesothelioma

Advanced Lung Non-Small Cell Squamous Carcinoma

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

Metastatic Carcinoma to the Uterine Cervix

Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Estrogen receptor-negative breast cancer

Hormone receptor positive HER2 negative breast cancer

Resectable Lung Non-Small Cell Carcinoma

Locally Advanced Clear Cell Renal Cell Carcinoma

Estrogen receptor positive breast cancer

Metastatic Clear Cell Renal Cell Carcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Metastatic castration-resistant prostate cancer

Metastatic Malignant Neoplasm to the Leptomeninges

Neuroendocrine neoplasm of gastrointestinal tract

Refractory Differentiated Thyroid Gland Carcinoma

RET fusion-positive  Adenocarcinoma of Lung

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


Squamous Cell Carcinoma of Head and Neck


Recombinant human VEGF receptor-Fc fusion protein

Retinal vein occlusion-related macular edema

Advanced Gastroesophageal Junction Adenocarcinoma

Malignant neoplasm of gastro-oesophageal junction


Chlorpheniramine Maleate/Scopolamine Hydrobromide Hydrate/Anhydrous Caffeine/Nicotinamide/Pyridoxine Hydrochloride


Trastuzumab Deruxtecan (Genetical Recombination)

Hormone receptor positive HER2 positive breast cancer

HER2 positive Gastroesophageal Junction Adenocarcinoma

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

HER2 positive Gastrooesophageal junction cancer

Metastatic HER2 positive gastroesophageal junction cancer

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Metastatic castration-resistant prostate cancer

Metastatic HER2-Negative Breast Carcinoma

Locally Advanced Malignant Solid Neoplasm

Metastatic Malignant Neoplasm to the Leptomeninges

Hormone Receptor Positive Breast Adenocarcinoma

HER2 Positive Gastroesophageal Adenocarcinoma

Locally Advanced Lung Non-Small Cell Carcinoma

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

HER2-expressing Gastroesophageal Junction Adenocarcinoma

Mismatch repair-deficient Endometrial Carcinoma

HER2 Positive Transitional Cell Carcinoma

Urothelial Carcinoma of the Urinary Bladder

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


Bevacizumab Biosimilar (Curateq Biologics Pvt Ltd.)

EGFR positive Non-squamous non-small cell lung cancer

Platinum-sensitive epithelial ovarian cancer

Platinum-Sensitive Fallopian Tube Carcinoma

Platinum-Sensitive Primary Peritoneal Carcinoma

Recurrent Platinum-Resistant Fallopian Tube Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

Recurrent Platinum-Resistant Primary Peritoneal Carcinoma

Unresectable Lung Non-Small Cell Carcinoma


Polyradiculoneuropathy, Chronic Inflammatory Demyelinating


Estrogen receptor-negative breast cancer

China
European Union
Japan
Iceland
Liechtenstein
Norway


Muscle-type nicotinic acetylcholine receptor

United States
China
Japan
Australia
South Korea


Multifocal acquired demyelinating sensory and motor neuropathy

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


Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (disulfide bridge: 1-6; 2-10; 5-13)

Irritable bowel syndrome with constipation

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


Immunoglobulin g1, anti-(human neonatal fc receptor) (human monoclonal m281 .gamma.-1 chain), disulfide with human monoclonal m281 .lambda.-chain, dimer

anti-FcRn monoclonal antibody(Momenta Pharmaceuticals)

Fetal and neonatal alloimmune thrombocytopenia

United States
European Union
Japan
Canada
Iceland
Liechtenstein
Norway


Maturity onset diabetes mellitus in young

Metabolic Dysfunction Associated Steatohepatitis

United States
China
European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


European Union
Iceland
Liechtenstein
Norway


Cystic fibrosis transmembrane conductance regulator

United States
European Union
Canada
Australia
Switzerland
Iceland
Liechtenstein
Norway


recombinant respiratory syncytial virus pre-fusion F protein, water for injections(Pfizer)

Pneumonia due to respiratory syncytial virus

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


Sarilumab (genetical receombination) (JAN)

Polyarticular Juvenile Idiopathic Arthritis

Systemic onset juvenile chronic arthritis

United States
European Union
Japan
Canada
Australia
Iceland
Liechtenstein
Norway


Filgrastim  Biosimilar (Tanvex BioPharma, Inc.)


Cytotoxic T-Lymphocyte-Associated Antigen 4

Microsatellite instability-high Rectal Cancer

PD-L1 positive Non-Small Cell Lung Cancer

Mismatch repair-deficient Colonic Cancer

Unresectable Esophageal Squamous Cell Carcinoma

Metastatic Esophageal Squamous Cell Carcinoma

Oesophageal squamous cell carcinoma recurrent

Unresectable Pleural Malignant Mesothelioma

Microsatellite instability-high colorectal cancer

Locally Advanced Lung Non-Small Cell Carcinoma

Metastatic Gastroesophageal Junction Adenocarcinoma

Metastatic Clear Cell Renal Cell Carcinoma

Mismatch repair-deficient Endometrial Carcinoma

Urothelial Carcinoma of the Urinary Bladder

Metastatic Microsatellite Stable Colorectal Carcinoma

Refractory Differentiated Thyroid Gland Carcinoma

thyroid gland poorly differentiated carcinoma

Squamous Cell Carcinoma of Head and Neck

HPV positive oropharyngeal squamous cell carcinoma

Locally Advanced Head and Neck Squamous Cell Carcinoma

Metastatic Urethral Urothelial Carcinoma

Muscle Invasive Bladder Urothelial Carcinoma

Small cell neuroendocrine carcinoma of bladder

Human epidermal growth factor 2 negative carcinoma of breast

Metastatic HER2-Negative Breast Carcinoma

Primary Peritoneal High-Grade Serous Adenocarcinoma

Renal Pelvis and Ureter Urothelial Carcinoma

Squamous Cell Carcinoma of the Nasal Cavity

Undifferentiated carcinoma of nasopharynx

Well Differentiated Pancreatic Endocrine Tumor

Squamous cell carcinoma of the oral cavity

Metastatic castration-resistant prostate cancer

Resectable Lung Non-Small Cell Carcinoma

Metastatic Triple-Negative Breast Carcinoma

Unresectable Lung Non-Small Cell Carcinoma

Platinum-Resistant Fallopian Tube Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma

Recurrent B Acute Lymphoblastic Leukemia

Recurrent Mixed Phenotype Acute Leukemia

Refractory B Acute Lymphoblastic Leukemia

Refractory Mixed Phenotype Acute Leukemia

Acute Myeloid Leukemia with Myelodysplasia-Related Changes

Peripheral T-cell lymphoma unspecified refractory

Recurrent Anaplastic Large Cell Lymphoma

Refractory Systemic Anaplastic Large Cell Lymphoma

Sarcomatoid Transitional Cell Carcinoma of the Renal Pelvis

Advanced Esophageal Squamous Cell Carcinoma

Aggressive-Phase Chronic Myelocytic Leukemia

BCR-ABL Negative Atypical Chronic Myeloid Leukemia

Chronic lymphocytic leukaemia refractory

Diffuse large B-cell lymphoma refractory

EGFR positive Non-squamous non-small cell lung cancer

GRPR Positive/ER Positive/HER2 Negative Breast Cancer

HER2 Positive Gastroesophageal Adenocarcinoma

Human Papillomavirus-Related Cervical Carcinoma

KRAS-mutated low-grade serous ovarian cancer

Locally Advanced Hepatocellular Carcinoma

Locally Advanced Pancreatic Adenocarcinoma

Malignant neoplasm of gastro-oesophageal junction

Metastatic Gastrointestinal Stromal Tumor

Metastatic Malignant Neoplasm to the Leptomeninges

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Philadelphia chromosome positive chronic myelogenous leukemia

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Adult Grade III Lymphomatoid Granulomatosis

Recurrent Gastroesophageal Junction Adenocarcinoma

Recurrent Lung Non-Squamous Non-Small Cell Carcinoma

Recurrent Platinum-Resistant Ovarian Carcinoma

Refractory Central Nervous System Lymphoma

Refractory High Risk Myelodysplastic Syndrome

Squamous cell carcinoma of head and neck metastatic

Squamous cell carcinoma of the hypopharynx

Stage II Non-Contiguous Adult Diffuse Small Cleaved Cell Lymphoma

Treatment related acute myeloid leukaemia

Unresectable Gastrointestinal Stromal Tumor


Bevacizumab biosimilar (Bio-Thera Solutions)

Bevacizumab Biosimilar (Bio-Thera Solutions, Ltd.)

EGFR positive Non-squamous non-small cell lung cancer

Platinum-sensitive epithelial ovarian cancer

Platinum-Sensitive Fallopian Tube Carcinoma

Platinum-Sensitive Primary Peritoneal Carcinoma

Recurrent Platinum-Resistant Fallopian Tube Carcinoma

Recurrent Platinum-Resistant Primary Peritoneal Carcinoma

Unresectable Lung Non-Small Cell Carcinoma

Locally Advanced Hepatocellular Carcinoma

Advanced Lung Non-Squamous Non-Small Cell Carcinoma

United States
China
European Union
Brazil
Iceland
Liechtenstein
Norway


Valsartan/Amlodipine Besylate/Pitavastatin Calcium Hydrate