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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

oritavancin diphosphate

Skin Diseases, Bacterial Soft Tissue Infections 2015-03-19           Authorised
Mycamine

micafungin

Candidiasis 2008-04-25           Authorised
Janumet

sitagliptin / metformin hydrochloride

Diabetes Mellitus, Type 2 2008-07-16           Authorised
Resolor

prucalopride succinate

Constipation 2009-10-15           Authorised
Xeloda

capecitabine

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

roflumilast

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

buprenorphine / naloxone

Opioid-Related Disorders 2006-09-26           Authorised
Eptifibatide Accord

eptifibatide

Myocardial Infarction 2016-01-11           Authorised
Filgrastim Hexal

filgrastim

Cancer Hematopoietic Stem Cell Transplantation Neutropenia 2009-02-06           Authorised
Exforge HCT

amlodipine besylate / valsartan / hydrochlorothiazide

Hypertension 2009-10-16           Authorised
Altargo

retapamulin

Impetigo Staphylococcal Skin Infections 2007-05-24           Authorised
Biopoin

epoetin theta

Anemia Cancer Kidney Failure, Chronic 2009-10-23           Authorised
Ivabradine Anpharm

ivabradine

Angina Pectoris 2015-09-08           Authorised
Ibandronic Acid Sandoz

ibandronic acid

Breast Neoplasms Fractures, Bone Neoplasm Metastasis 2011-07-26           Authorised
Oprymea

pramipexole dihydrochloride monohydrate

Parkinson Disease 2008-09-12           Authorised
Myfenax

mycophenolate mofetil

Graft Rejection 2008-02-21           Authorised
Pregabalin Mylan Pharma

pregabalin

Anxiety Disorders Epilepsy Neuralgia 2015-06-25           Authorised
Scintimun

besilesomab

Osteomyelitis Radionuclide Imaging 2010-01-11           Authorised
Mircera

methoxy polyethylene glycol-epoetin beta

Anemia Kidney Failure, Chronic 2007-07-20           Authorised
Envarsus

tacrolimus

Graft Rejection 2014-07-18           Authorised
Olazax Disperzi

olanzapine

Bipolar Disorder Schizophrenia 2009-12-10           Authorised
M-M-RVaxPro

measles virus Enders’ Edmonston strain (live, attenuated) / mumps virus Jeryl Lynn (level B) strain (live, attenuated) / rubella virus Wistar RA 27/3 strain (live, attenuated)

Immunization Measles Mumps Rubella 2006-05-05           Authorised
Onbrez Breezhaler

indacaterol maleate

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

human fibrinogen / human thrombin

Hemostasis, Surgical 2008-10-06           Authorised
Diacomit

stiripentol

Myoclonic Epilepsy, Juvenile 2007-01-04           Authorised