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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

octocog alfa

Hemophilia A 2000-08-04           Authorised
Cholestagel

colesevelam

Hypercholesterolemia 2004-03-10           Authorised
Vantobra

tobramycin

Cystic Fibrosis Respiratory Tract Infections 2015-03-18           Authorised
Levetiracetam Teva

levetiracetam

Epilepsy 2011-08-26           Authorised
Viagra

sildenafil

Erectile Dysfunction 1998-09-14           Authorised
Fexeric

ferric citrate coordination complex

Hyperphosphatemia Renal Dialysis 2015-09-23           Authorised
Xiliarx

vildagliptin

Diabetes Mellitus, Type 2 2008-11-19           Authorised
Granupas (previously Para-aminosalicylic acid Lucane)

para-aminosalicylic acid

Tuberculosis 2014-04-07           Authorised
MicardisPlus

telmisartan / hydrochlorothiazide

Hypertension 2002-04-19           Authorised
Cervarix

human papillomavirus1 type 16 L1 protein / human papillomavirus type 18 L1 protein

Immunization Papillomavirus Infections Uterine Cervical Dysplasia 2007-09-20           Authorised
Levetiracetam Sun

levetiracetam

Epilepsy 2011-12-14           Authorised
Enurev Breezhaler

glycopyrronium bromide

Pulmonary Disease, Chronic Obstructive 2012-09-28           Authorised
Repaglinide Accord

repaglinide

Diabetes Mellitus, Type 2 2011-12-22           Authorised
Nimenrix

Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid

Meningitis, Meningococcal 2012-04-20           Authorised
Pregabalin Zentiva

pregabalin

Anxiety Disorders Epilepsy 2015-07-17           Authorised
Ovaleap

follitropin alfa

Anovulation 2013-09-27           Authorised
Amlodipine / Valsartan Mylan

amlodipine besilate / valsartan

Hypertension 2016-03-22           Authorised
Ferriprox

deferiprone

Iron Overload beta-Thalassemia 1999-08-25           Authorised
Halaven

eribulin

Breast Neoplasms Liposarcoma 2011-03-17           Authorised
Iasibon

ibandronic acid

Breast Neoplasms Fractures, Bone Hypercalcemia Neoplasm Metastasis 2011-01-21           Authorised
Trelegy Ellipta

fluticasone furoate, umeclidinium bromide, vilanterol trifenatate

Pulmonary Disease, Chronic Obstructive 2017-11-15           Authorised
Pemetrexed Lilly

pemetrexed

Carcinoma, Non-Small-Cell Lung Mesothelioma 2015-09-14           Authorised
TachoSil

human fibrinogen / human thrombin

Hemostasis, Surgical 2004-06-08           Authorised
Blincyto

blinatumomab

Precursor Cell Lymphoblastic Leukemia-Lymphoma 2015-11-23           Authorised
Cholib

fenofibrate / simvastatin

Dyslipidemias 2013-08-26           Authorised