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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

elbasvir / grazoprevir

Hepatitis C, Chronic 2016-07-22           Authorised
Zerit

stavudine

HIV Infections 1996-05-08           Authorised
Ikervis

ciclosporin

Corneal Diseases 2015-03-19           Authorised
Ammonaps

sodium phenylbutyrate

Carbamoyl-Phosphate Synthase I Deficiency Disease Citrullinemia Ornithine Carbamoyltransferase Deficiency Disease 1999-12-08           Authorised
Capecitabine Accord

capecitabine

Breast Neoplasms Colonic Neoplasms Colorectal Neoplasms Stomach Neoplasms 2012-04-20           Authorised
Fiasp

insulin aspart

Diabetes Mellitus 2017-01-09           Authorised
DepoCyte

cytarabine

Meningeal Neoplasms 2001-07-11           Authorised
Axura

memantine hydrochloride

Alzheimer Disease 2002-05-17           Authorised
Telmisartan Teva

telmisartan

Hypertension 2010-01-26           Authorised
Savene

dexrazoxane hydrochloride

Extravasation of Diagnostic and Therapeutic Materials 2006-07-28           Authorised
Adenuric

febuxostat

Gout 2008-04-21           Authorised
Trizivir

abacavir (as sulfate) / lamivudine / zidovudine

HIV Infections 2000-12-28           Authorised
Desloratadine Teva

desloratadine

Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal 2011-11-24           Authorised
Xgeva

denosumab

Fractures, Bone Neoplasm Metastasis 2011-07-13           Authorised
Voncento

human coagulation factor VIII / human von willebrand factor

Hemophilia A von Willebrand Diseases 2013-08-12           Authorised
Raloxifene Teva

raloxifene hydrochloride

Osteoporosis, Postmenopausal 2010-04-29           Authorised
Protelos

strontium ranelate

Osteoporosis, Postmenopausal 2004-09-21           Authorised
Ribavirin Teva Pharma B.V.

ribavirin

Hepatitis C, Chronic 2009-07-01           Authorised
Replagal

agalsidase alfa

Fabry Disease 2001-08-03           Authorised
BeneFIX

nonacog alfa

Hemophilia B 1997-08-27           Authorised
Repaglinide Teva

repaglinide

Diabetes Mellitus, Type 2 2009-06-29           Authorised
Ritemvia

rituximab

Lymphoma, Non-Hodgkin Microscopic Polyangiitis Wegener Granulomatosis 2017-07-13           Authorised
Docetaxel Teva

docetaxel

Adenocarcinoma Breast Neoplasms Carcinoma, Non-Small-Cell Lung Head and Neck Neoplasms Prostatic Neoplasms Stomach Neoplasms 2010-01-26           Authorised
Rotarix

human rotavirus, live attenuated

Immunization Rotavirus Infections 2006-02-21           Authorised
Rivastigmine 1 A Pharma

rivastigmine

Alzheimer Disease Dementia Parkinson Disease 2009-12-11           Authorised