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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

irbesartan

Hypertension 1997-08-27           Authorised
Xeloda

capecitabine

Breast Neoplasms Colonic Neoplasms Colorectal Neoplasms Stomach Neoplasms 2001-02-02           Authorised
NovoNorm

repaglinide

Diabetes Mellitus, Type 2 1998-08-17           Authorised
Daxas

roflumilast

Pulmonary Disease, Chronic Obstructive 2010-07-05           Authorised
Suboxone

buprenorphine / naloxone

Opioid-Related Disorders 2006-09-26           Authorised
Alecensa

alectinib hydrochloride

Carcinoma, Non-Small-Cell Lung 2017-02-16           Authorised
Eptifibatide Accord

eptifibatide

Myocardial Infarction 2016-01-11           Authorised
Temozolomide Accord

temozolomide

Glioblastoma Glioma 2010-03-15           Authorised
Advate

octocog alfa

Hemophilia A 2004-03-02           Authorised
Prometax

rivastigmine

Alzheimer Disease Dementia Parkinson Disease 1998-12-04           Authorised
Clopidogrel ratiopharm

clopidogrel hydrogen sulphate

Acute Coronary Syndrome Myocardial Infarction Peripheral Vascular Diseases Stroke 2015-02-19           Authorised
Exforge HCT

amlodipine besylate / valsartan / hydrochlorothiazide

Hypertension 2009-10-16           Authorised
Altargo

retapamulin

Impetigo Staphylococcal Skin Infections 2007-05-24           Authorised
Ivabradine Anpharm

ivabradine

Angina Pectoris 2015-09-08           Authorised
Enurev Breezhaler

glycopyrronium bromide

Pulmonary Disease, Chronic Obstructive 2012-09-28           Authorised
Ibandronic Acid Sandoz

ibandronic acid

Breast Neoplasms Fractures, Bone Neoplasm Metastasis 2011-07-26           Authorised
Pemetrexed Hospira UK Limited

pemetrexed ditromethamine

Carcinoma, Non-Small-Cell Lung Mesothelioma 2017-04-24           Authorised
Protopic

tacrolimus

Dermatitis, Atopic 2002-02-28           Authorised
Resolor

prucalopride succinate

Constipation 2009-10-15           Authorised
Stocrin

efavirenz

HIV Infections 1999-05-28           Authorised
Bortezomib Accord

bortezomib

Multiple Myeloma 2015-07-20           Authorised
Myfenax

mycophenolate mofetil

Graft Rejection 2008-02-21           Authorised
Kalydeco

ivacaftor

Cystic Fibrosis 2012-07-23           Authorised
Scintimun

besilesomab

Osteomyelitis Radionuclide Imaging 2010-01-11           Authorised
Abilify

aripiprazole

Bipolar Disorder Schizophrenia 2004-06-04           Authorised