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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

brentuximab vedotin

Hodgkin Disease Lymphoma, Non-Hodgkin 2012-10-25           Authorised
Adempas

riociguat

Hypertension, Pulmonary 2014-03-27           Authorised
Alprolix

eftrenonacog alfa

Hemophilia B 2016-05-12           Authorised
Arzerra

ofatumumab

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

avelumab

Neuroendocrine Tumors 2017-09-18           Authorised
Besponsa

inotuzumab ozogamicin

Precursor Cell Lymphoblastic Leukemia-Lymphoma 2017-06-29           Authorised
Blincyto

blinatumomab

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

bosutinib (as monohydrate)

  2013-03-27           Authorised
Brineura

cerliponase alfa

Neuronal Ceroid-Lipofuscinoses 2017-05-30           Authorised
Bronchitol

mannitol

Cystic Fibrosis 2012-04-13           Authorised
Carbaglu

carglumic acid

Amino Acid Metabolism, Inborn Errors Propionic Acidemia 2003-01-24           Authorised
Cayston

aztreonam lysine

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

histamine dihydrochloride

Leukemia, Myeloid, Acute 2008-10-07           Authorised
Cerdelga

eliglustat

Gaucher Disease 2015-01-19           Authorised
Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)

chenodeoxycholic acid

Metabolism, Inborn Errors Xanthomatosis, Cerebrotendinous 2017-04-10           Authorised
Coagadex

human coagulation factor X

Factor X Deficiency 2016-03-16           Authorised
Cometriq

cabozantinib

Thyroid Neoplasms 2014-03-21           Authorised
Cresemba

isavuconazole

Aspergillosis 2015-10-15           Authorised
Cystadrops

mercaptamine hydrochloride

Cystinosis 2017-01-19           Authorised
Dacogen

decitabine

Leukemia, Myeloid 2012-09-20           Authorised
Darzalex

daratumumab

Multiple Myeloma 2016-05-20           Authorised
Defitelio

defibrotide

Hepatic Veno-Occlusive Disease 2013-10-18           Authorised
Deltyba

delamanid

Tuberculosis, Multidrug-Resistant 2014-04-28           Authorised
Dinutuximab beta EUSA (previously Dinutuximab beta Apeiron)

dinutuximab beta

Neuroblastoma 2017-05-08           Authorised
Dropcys

mercaptamine

Corneal Diseases Cystinosis 2016-06-24           Refused