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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

azacitidine

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

thalidomide

Multiple Myeloma 2008-04-16           Authorised
Peyona (previously Nymusa)

caffeine citrate

Apnea 2009-07-02           Authorised
Procysbi

mercaptamine bitartrate

Cystinosis 2013-09-06           Authorised
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
Dacogen

decitabine

Leukemia, Myeloid 2012-09-20           Authorised
Granupas (previously Para-aminosalicylic acid Lucane)

para-aminosalicylic acid

Tuberculosis 2014-04-07           Authorised
Xaluprine (previously Mercaptopurine Nova Laboratories)

6-mercaptopurine monohydrate

Leukemia, Lymphoid 2012-03-09           Authorised
Tasigna

nilotinib

Leukemia, Myelogenous, Chronic, BCR-ABL Positive 2007-11-19           Authorised
Arzerra

ofatumumab

Leukemia, Lymphocytic, Chronic, B-Cell 2010-04-19           Authorised
Votubia

everolimus

Tuberous Sclerosis 2011-09-02           Authorised