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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

pitolisant

Narcolepsy 2016-03-31           Authorised
Envarsus

tacrolimus

Graft Rejection 2014-07-18           Authorised
Olazax Disperzi

olanzapine

Bipolar Disorder Schizophrenia 2009-12-10           Authorised
Evicel

human fibrinogen / human thrombin

Hemostasis, Surgical 2008-10-06           Authorised
Diacomit

stiripentol

Myoclonic Epilepsy, Juvenile 2007-01-04           Authorised
Ocaliva

obeticholic acid

Liver Cirrhosis, Biliary 2016-12-12           Authorised
Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)

split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)

Disease Outbreaks Immunization Influenza, Human 2009-10-10           Authorised
Torisel

temsirolimus

Carcinoma, Renal Cell Lymphoma, Mantle-Cell 2007-11-19           Authorised
Trimbow

beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium bromide

Pulmonary Disease, Chronic Obstructive 2017-07-17           Authorised
Irbesartan Teva

irbesartan

Hypertension 2009-10-30           Authorised
Pravafenix

fenofibrate / pravastatin

Dyslipidemias 2011-04-14           Authorised
Temozolomide Accord

temozolomide

Glioblastoma Glioma 2010-03-15           Authorised
Lamivudine Teva

lamivudine

Hepatitis B, Chronic 2009-10-23           Authorised
Vargatef

nintedanib

Carcinoma, Non-Small-Cell Lung 2014-11-21           Authorised
Tractocile

atosiban acetate

Premature Birth 2000-01-20           Authorised
Cancidas (previously Caspofungin MSD)

caspofungin

Aspergillosis Candidiasis 2001-10-24           Authorised
Neparvis

sacubitril / valsartan

Heart Failure 2016-05-26           Authorised
Nexavar

sorafenib

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

alogliptin benzoate / metformin hydrochloride

Diabetes Mellitus, Type 2 2013-09-19           Authorised
Integrilin

eptifibatide

Angina, Unstable Myocardial Infarction 1999-07-01           Authorised
Lonquex

lipegfilgrastim

Neutropenia 2013-07-25           Authorised
ATryn

antithrombin alfa

Antithrombin III Deficiency 2006-07-28           Authorised
Duloxetine Lilly

duloxetine

Diabetic Neuropathies Neuralgia 2014-12-08           Authorised
Valdoxan

agomelatine

Depressive Disorder, Major 2009-02-19           Authorised
Zerit

stavudine

HIV Infections 1996-05-08           Authorised