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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

human insulin

Diabetes Mellitus 2002-10-07           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
Procoralan

ivabradine hydrochloride

Angina Pectoris 2005-10-25           Authorised
Signifor

pasireotide

Acromegaly Pituitary ACTH Hypersecretion 2012-04-24           Authorised
Leflunomide medac

leflunomide

Arthritis, Rheumatoid 2010-07-27           Authorised
Vargatef

nintedanib

Carcinoma, Non-Small-Cell Lung 2014-11-21           Authorised
Oslif Breezhaler

indacaterol maleate

Pulmonary Disease, Chronic Obstructive 2009-11-30           Authorised
Aerius

desloratadine

Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Urticaria 2001-01-15           Authorised
Spedra

avanafil

Erectile Dysfunction 2013-06-21           Authorised
Emselex

darifenacin hydrobromide

Urinary Bladder, Overactive Urinary Incontinence, Urge 2004-10-22           Authorised
Tractocile

atosiban acetate

Premature Birth 2000-01-20           Authorised
Viramune

nevirapine

HIV Infections 1998-02-05           Authorised
Javlor

vinflunine

Carcinoma, Transitional Cell Urologic Neoplasms 2009-09-21           Authorised
Cancidas (previously Caspofungin MSD)

caspofungin

Aspergillosis Candidiasis 2001-10-24           Authorised
Twinrix Adult

hepatitis A virus (inactivated) / hepatitis B surface antigen

Hepatitis A Hepatitis B Immunization 1996-09-20           Authorised
Integrilin

eptifibatide

Angina, Unstable Myocardial Infarction 1999-07-01           Authorised
Abilify Maintena

aripiprazole

Schizophrenia 2013-11-15           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
Zepatier

elbasvir / grazoprevir

Hepatitis C, Chronic 2016-07-22           Authorised
Zerit

stavudine

HIV Infections 1996-05-08           Authorised