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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Summaries of opinion Remove Summaries of opinion filter Withdrawn applications Remove Withdrawn applications filter

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Medicine type Accelerated assessment Remove Accelerated assessment filter Exceptional circumstances Remove Exceptional circumstances filter Biosimilar Remove Biosimilar filter Conditional approval Remove Conditional approval filter

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Human medicine European public assessment report (EPAR): Blenrep (updated)

belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020, , , , Revision: 2, Authorised, Last updated: 17/03/2021
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Human medicine European public assessment report (EPAR): Naglazyme (updated)

galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006, , , Revision: 18, Authorised, Last updated: 17/03/2021
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Human medicine European public assessment report (EPAR): Viekirax

Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015, , , Revision: 22, Authorised, Last updated: 12/03/2021
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Human medicine European public assessment report (EPAR): Foclivia

influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009, , Revision: 11, Authorised, Last updated: 10/03/2021
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Human medicine European public assessment report (EPAR): Ninlaro

ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016, , , , Revision: 9, Authorised, Last updated: 03/03/2021
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Human medicine European public assessment report (EPAR): Maviret

glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017, , , Revision: 11, Authorised, Last updated: 03/03/2021
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Human medicine European public assessment report (EPAR): Vyndaqel

tafamidis, Amyloidosis
Date of authorisation: 16/11/2011, , , , Revision: 18, Authorised, Last updated: 02/03/2021
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Human medicine European public assessment report (EPAR): Flixabi

infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis
Date of authorisation: 26/05/2016, , , Revision: 16, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Herzuma

trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 08/02/2018, , , Revision: 11, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Ondexxya

andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019, , , Revision: 8, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Vpriv

velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010, , , Revision: 14, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Inhixa

enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016, , , Revision: 17, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Prepandrix

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 14/05/2008, , Revision: 13, Withdrawn, Last updated: 23/02/2021
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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: 22, Authorised, Last updated: 23/02/2021
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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: 13, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Nepexto

etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis
Date of authorisation: 20/05/2020, , , Revision: 3, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Kanjinti

trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 16/05/2018, , , Revision: 7, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Spinraza

nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017, , , , Revision: 11, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Crysvita

Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018, , , , Revision: 7, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Udenyca

pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018, , , Revision: 3, Withdrawn, Last updated: 15/02/2021
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Human medicine European public assessment report (EPAR): Ritemvia

rituximab, Lymphoma, Non-Hodgkin, Microscopic Polyangiitis, Wegener Granulomatosis
Date of authorisation: 13/07/2017, , , Revision: 8, Authorised, Last updated: 11/02/2021
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Human medicine European public assessment report (EPAR): Blitzima

rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017, , , Revision: 10, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Ontruzant

trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017, , , Revision: 8, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Insulin aspart Sanofi

insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020, , Revision: 1, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Praxbind

idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015, , Revision: 9, Authorised, Last updated: 08/02/2021