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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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
Masiviera

masitinib

Pancreatic Neoplasms 2014-05-22           Refused
Zavesca

miglustat

Gaucher Disease Niemann-Pick Diseases 2002-11-20           Authorised
Ledaga

chlormethine

Mycosis Fungoides 2017-03-03           Authorised
Siklos

hydroxycarbamide

Anemia, Sickle Cell 2007-06-29           Authorised
Tepadina

thiotepa

Hematopoietic Stem Cell Transplantation 2010-03-15           Authorised
SomaKit TOC

edotreotide

Neuroendocrine Tumors Radionuclide Imaging 2016-12-08           Authorised
Soliris

eculizumab

Hemoglobinuria, Paroxysmal 2007-06-20           Authorised
Folotyn

pralatrexate

Lymphoma, T-Cell 2012-06-21           Refused
Nplate

romiplostim

Purpura, Thrombocytopenic, Idiopathic 2009-02-04           Authorised
Onivyde

irinotecan hydrochloride trihydrate

Pancreatic Neoplasms 2016-10-14           Authorised
Nexavar

sorafenib

Carcinoma, Hepatocellular Carcinoma, Renal Cell 2006-07-19           Authorised
Kuvan

sapropterin dihydrochloride

Phenylketonurias 2008-12-02           Authorised
Lympreva

dasiprotimut-t

Lymphoma, Non-Hodgkin 2015-07-03           Refused
Vidaza

azacitidine

Myelodysplastic Syndromes 2008-12-17           Authorised
Thalidomide Celgene (previously Thalidomide Pharmion)

thalidomide

Multiple Myeloma 2008-04-16           Authorised
Istodax

romidepsin

Lymphoma, Non-Hodgkin 2013-02-12           Refused
Sovrima

idebenone

Friedreich Ataxia 2009-04-27           Refused
Peyona (previously Nymusa)

caffeine citrate

Apnea 2009-07-02           Authorised
Procysbi

mercaptamine bitartrate

Cystinosis 2013-09-06           Authorised
Heparesc

human heterologous liver cells

Urea Cycle Disorders, Inborn 2015-12-21           Refused
Inovelon

rufinamide

Epilepsy 2007-01-16           Authorised
Lartruvo

olaratumab

Sarcoma 2016-11-09           Authorised
Mozobil

plerixafor

Hematopoietic Stem Cell Transplantation Lymphoma Multiple Myeloma 2009-07-31           Authorised
Cayston

aztreonam lysine

Cystic Fibrosis Respiratory Tract Infections 2009-09-21           Authorised
Volibris

ambrisentan

Hypertension, Pulmonary 2008-04-21           Authorised