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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1)

Disease Outbreaks Immunization Influenza, Human 2009-10-19           Authorised
Vizamyl

flutemetamol (18F)

Alzheimer Disease Radionuclide Imaging 2014-08-22           Authorised
Invirase

saquinavir

HIV Infections 1996-10-04           Authorised
Glubrava

metformin hydrochloride / pioglitazone hydrochloride

Diabetes Mellitus, Type 2 2007-12-11           Authorised
Ristfor

sitagliptin / metformin hydrochloride

Diabetes Mellitus, Type 2 2010-03-15           Authorised
Vfend

voriconazole

Aspergillosis Candidiasis Mycoses 2002-03-19           Authorised
Somavert

pegvisomant

Acromegaly 2002-11-13           Authorised
Zyprexa

olanzapine

Bipolar Disorder Schizophrenia 1996-09-27           Authorised
Ebixa

memantine hydrochloride

Alzheimer Disease 2002-05-15           Authorised
DaTSCAN

ioflupane (123l)

Alzheimer Disease Lewy Body Disease Parkinson Disease Tomography, Emission-Computed, Single-Photon 2000-07-27           Authorised
ellaOne

ulipristal

Contraception, Postcoital 2009-05-15           Authorised
Effentora

fentanyl

Cancer Pain 2008-04-04           Authorised
ReFacto AF

moroctocog alfa

Hemophilia A 1999-04-13           Authorised
Obizur

susoctocog alfa

Hemophilia A 2015-11-11           Authorised
Nitisinone MDK (previously Nitisinone MendeliKABS)

nitisinone

Tyrosinemias 2017-08-24           Authorised
Xaluprine (previously Mercaptopurine Nova Laboratories)

6-mercaptopurine monohydrate

Leukemia, Lymphoid 2012-03-09           Authorised
Ecansya (previously Capecitabine Krka)

capecitabine

Breast Neoplasms Colonic Neoplasms Colorectal Neoplasms Stomach Neoplasms 2012-04-20           Authorised
Crixivan

indinavir sulphate

HIV Infections 1996-10-04           Authorised
Bronchitol

mannitol

Cystic Fibrosis 2012-04-13           Authorised
Adempas

riociguat

Hypertension, Pulmonary 2014-03-27           Authorised
NovoSeven

eptacog alfa (activated)

Factor VII Deficiency Hemophilia A Hemophilia B Thrombasthenia 1996-02-23           Authorised
Cosentyx

secukinumab

Arthritis, Psoriatic Psoriasis Spondylitis, Ankylosing 2015-01-15           Authorised
Pritor

telmisartan

Hypertension 1998-12-11           Authorised
Cabometyx

cabozantinib s-malate

Carcinoma, Renal Cell 2016-09-09           Authorised
Xermelo

telotristat etiprate

Carcinoid Tumor Neuroendocrine Tumors 2017-09-18           Authorised