European public assessment reports

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This page allows you to find the European public assessment reports (EPAR) for human medicines published by the European Medicines Agency (EMA).

The EMA publishes an EPAR for every medicine granted a central marketing authorisation by the European Commission following an assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). EPARs are full scientific assessment reports of medicines authorised at a European Union level. 

Use this search to find information including a public-friendly summary in question-and-answer format and the package leaflet. You can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.

As of October 2016, EMA publishes the clinical data submitted by pharmaceutical companies to support their marketing applications for human medicines under the centralised procedure, allowing the public to better understand the Agency’s decision-making. For more information see clinical data publication.

The Agency does not evaluate all medicines currently in use in Europe. If you cannot find the medicine you need through this search, please visit the website of your national health authority.

More information is available on the Central authorisation procedure and in EPARs: background and context.

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EPAR Search results
Name Active substance Therapeutic area Date of authorisation / refusal Additional monitoring Orphan     Has current safety alert Status
Masican

masitinib

Gastrointestinal Stromal Tumors 2014-07-04           Refused
Venclyxto

venetoclax

Leukemia, Lymphocytic, Chronic, B-Cell 2016-12-05           Authorised
Opsumit

macitentan

Hypertension, Pulmonary 2013-12-20           Authorised
Kanuma

sebelipase alfa

Lipid Metabolism, Inborn Errors 2015-08-28           Authorised
Strensiq

asfotase alfa

Hypophosphatasia 2015-08-28           Authorised
Blincyto

blinatumomab

Precursor Cell Lymphoblastic Leukemia-Lymphoma 2015-11-23           Authorised
Kyprolis

carfilzomib

Multiple Myeloma 2015-11-19           Authorised
Galafold

migalastat hydrochloride

Fabry Disease 2016-05-26           Authorised
Iclusig

ponatinib

Leukemia, Lymphoid Leukemia, Myeloid 2013-07-01           Authorised
Lynparza

olaparib

Ovarian Neoplasms 2014-12-16           Authorised
Cresemba

isavuconazole

Aspergillosis 2015-10-15           Authorised
Adempas

riociguat

Hypertension, Pulmonary 2014-03-27           Authorised
Coagadex

human coagulation factor X

Factor X Deficiency 2016-03-16           Authorised
Firdapse (previously Zenas)

amifampridine

Lambert-Eaton Myasthenic Syndrome 2009-12-23           Authorised
Vimizim

recombinant human n-acetylgalactosamine-6-sulfatase (rhgalns)

Mucopolysaccharidosis IV 2014-04-28           Authorised
Brineura

cerliponase alfa

Neuronal Ceroid-Lipofuscinoses 2017-05-30           Authorised
Spinraza

nusinersen sodium

Muscular Atrophy, Spinal 2017-05-30           Authorised
Wakix

pitolisant

Narcolepsy 2016-03-31           Authorised
Ofev

nintedanib

Idiopathic Pulmonary Fibrosis 2015-01-15           Authorised
Idelvion

albutrepenonacog alfa

Hemophilia B 2016-05-11           Authorised
Imnovid (previously Pomalidomide Celgene)

pomalidomide

Multiple Myeloma 2013-08-05           Authorised
Revlimid

lenalidomide

Lymphoma, Mantle-Cell Multiple Myeloma Myelodysplastic Syndromes 2007-06-14           Authorised
Holoclar

ex vivo expanded autologous human corneal epithelial cells containing stem cells

Corneal Diseases Stem Cell Transplantation 2015-02-17           Authorised
Scenesse

afamelanotide

Protoporphyria, Erythropoietic 2014-12-22           Authorised
Oxervate

recombinant human Nerve Growth factor (rhNGF)

Keratitis 2017-07-06           Authorised