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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Referrals Remove Referrals filter

Medicine type Biosimilar Remove Biosimilar filter Accelerated assessment Remove Accelerated assessment filter Exceptional circumstances Remove Exceptional circumstances filter Generic Remove Generic filter

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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)

dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017, , , , Revision: 13, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Azacitidine Mylan

azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020, , Revision: 5, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Zalasta

olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 27/09/2007, , Revision: 20, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Pemetrexed Krka

pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/05/2018, , Revision: 6, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Hyrimoz

adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Date of authorisation: 26/07/2018, , , Revision: 10, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Lamzede

velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018, , , , Revision: 6, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Nimvastid

rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/05/2009, , Revision: 10, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Tolura

telmisartan, Hypertension
Date of authorisation: 04/06/2010, , Revision: 11, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Yargesa

miglustat, Gaucher Disease
Date of authorisation: 22/03/2017, , Revision: 5, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS)

nitisinone, Tyrosinemias
Date of authorisation: 24/08/2017, , Revision: 6, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Sapropterin Dipharma

Sapropterin dihydrochloride, Phenylketonurias
Date of authorisation: 16/02/2022, , Revision: 3, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Remsima

infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013, , Revision: 32, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Accofil

filgrastim, Neutropenia
Date of authorisation: 17/09/2014, , Revision: 13, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Thiotepa Riemser

thiotepa, Hematopoietic Stem Cell Transplantation; Neoplasms
Date of authorisation: 26/03/2021, , Revision: 3, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Darunavir Krka

darunavir, HIV Infections
Date of authorisation: 26/01/2018, , Revision: 9, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Strensiq

asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015, , , , Revision: 16, Authorised, Last updated: 15/02/2023
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Human medicine European public assessment report (EPAR): Hefiya

adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018, , , Revision: 11, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Benepali

etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016, , Revision: 19, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Azacitidine betapharm

azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020, , Revision: 5, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Filgrastim Hexal

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009, , Revision: 21, Authorised, Last updated: 10/02/2023
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Human medicine European public assessment report (EPAR): Zarzio

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009, , Revision: 22, Authorised, Last updated: 10/02/2023
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Human medicine European public assessment report (EPAR): Zercepac

trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 27/07/2020, , , Revision: 8, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Sylvant

siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014, , , Revision: 12, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Epclusa

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , Revision: 19, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Harvoni

ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014, , Revision: 27, Authorised, Last updated: 09/02/2023