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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

regadenoson

Myocardial Perfusion Imaging 2010-09-06           Authorised
Lemtrada

alemtuzumab

Multiple Sclerosis 2013-09-12           Authorised
Vipidia

alogliptin

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

oritavancin diphosphate

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

hepatitis B surface antigen

Hepatitis B Immunization 2005-02-02           Authorised
Mycamine

micafungin

Candidiasis 2008-04-25           Authorised
Oncaspar

pegaspargase

Precursor Cell Lymphoblastic Leukemia-Lymphoma 2016-01-14           Authorised
NeoRecormon

epoetin beta

Anemia Blood Transfusion, Autologous Cancer Kidney Failure, Chronic 1997-07-16           Authorised
Neoclarityn

desloratadine

Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Urticaria 2001-01-15           Authorised
Desloratadine Actavis

desloratadine

Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Urticaria 2012-01-13           Authorised
Kovaltry

octocog alfa

Hemophilia A 2016-02-18           Authorised
Neupro

rotigotine

Parkinson Disease Restless Legs Syndrome 2006-02-15           Authorised
CellCept

mycophenolate mofetil

Graft Rejection 1996-02-14           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
Alecensa

alectinib hydrochloride

Carcinoma, Non-Small-Cell Lung 2017-02-16           Authorised
Genvoya

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

HIV Infections 2015-11-19           Authorised
Eptifibatide Accord

eptifibatide

Myocardial Infarction 2016-01-11           Authorised
Filgrastim Hexal

filgrastim

Cancer Hematopoietic Stem Cell Transplantation Neutropenia 2009-02-06           Authorised
Advate

octocog alfa

Hemophilia A 2004-03-02           Authorised
Exforge HCT

amlodipine besylate / valsartan / hydrochlorothiazide

Hypertension 2009-10-16           Authorised
Altargo

retapamulin

Impetigo Staphylococcal Skin Infections 2007-05-24           Authorised
Hirobriz Breezhaler

indacaterol maleate

Pulmonary Disease, Chronic Obstructive 2009-11-30           Authorised