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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

pregabalin

Anxiety Disorders Epilepsy 2015-06-19           Authorised
Osseor

strontium ranelate

Osteoporosis, Postmenopausal 2004-09-21           Authorised
Atosiban SUN

atosiban acetate

Premature Birth 2013-07-31           Authorised
Xtandi

enzalutamide

Prostatic Neoplasms 2013-06-21           Authorised
Pregabalin Zentiva

pregabalin

Anxiety Disorders Epilepsy 2015-07-17           Authorised
NovoMix

insulin aspart

Diabetes Mellitus 2000-08-01           Authorised
Naglazyme

galsulfase

Mucopolysaccharidosis VI 2006-01-24           Authorised
Opdivo

nivolumab

Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Hodgkin Disease Melanoma 2015-06-19           Authorised
Ninlaro

ixazomib citrate

Multiple Myeloma 2016-11-21           Authorised
Efavirenz Teva

efavirenz

HIV Infections 2012-01-09           Authorised
Tasmar

tolcapone

Parkinson Disease 1997-08-27           Authorised
Alli (previously Orlistat GSK)

orlistat

Obesity 2007-07-23           Authorised
Anagrelide Mylan

anagrelide hydrochloride

Thrombocythemia, Essential 2018-02-15           Authorised
Entacapone Teva

entacapone

Parkinson Disease 2011-02-18           Authorised
Optison

perflutren

Echocardiography 1998-05-18           Authorised
Yttriga

yttrium [90Y] chloride

Radionuclide Imaging 2006-01-19           Authorised
Perjeta

pertuzumab

Breast Neoplasms 2013-03-04           Authorised
Xeplion

paliperidone palmitate

Schizophrenia 2011-03-04           Authorised
Foscan

temoporfin

Carcinoma, Squamous Cell Head and Neck Neoplasms 2001-10-24           Authorised
Dasselta

desloratadine

Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Urticaria 2011-11-28           Authorised
Samsca

tolvaptan

Inappropriate ADH Syndrome 2009-08-03           Authorised
Eurartesim

piperaquine tetraphosphate / artenimol

Malaria 2011-10-27           Authorised
Myocet

doxorubicin hydrochloride

Breast Neoplasms 2000-07-13           Authorised
Oxervate

recombinant human Nerve Growth factor (rhNGF)

Keratitis 2017-07-06           Authorised
Memantine Accord

memantine hydrochloride

Alzheimer Disease 2013-12-04           Authorised