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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

panitumumab

Colorectal Neoplasms 2007-12-03           Authorised
Rotarix

human rotavirus, live attenuated

Immunization Rotavirus Infections 2006-02-21           Authorised
Rivastigmine 1 A Pharma

rivastigmine

Alzheimer Disease Dementia Parkinson Disease 2009-12-11           Authorised
Sildenafil Teva

sildenafil

Erectile Dysfunction 2009-11-30           Authorised
Dynastat

parecoxib sodium

Pain, Postoperative 2002-03-22           Authorised
Trobalt

retigabine

Epilepsy 2011-03-28           Authorised
Azopt

brinzolamide

Glaucoma, Open-Angle Ocular Hypertension 2000-03-09           Authorised
Lamivudine/Zidovudine Teva

lamivudine / zidovudine

HIV Infections 2011-02-28           Authorised
Olysio

simeprevir

Hepatitis C, Chronic 2014-05-14           Authorised
Sildenafil Actavis

sildenafil

Erectile Dysfunction 2009-12-10           Authorised
Enyglid

repaglinide

Diabetes Mellitus, Type 2 2009-10-14           Authorised
Bondronat

ibandronic acid

Breast Neoplasms Fractures, Bone Hypercalcemia Neoplasm Metastasis 1996-06-25           Authorised
Fuzeon

enfuvirtide

HIV Infections 2003-05-27           Authorised
Baraclude

entecavir

Hepatitis B, Chronic 2006-06-26           Authorised
Luveris

lutropin alfa

Infertility, Female Ovulation Induction 2000-11-29           Authorised
Xyrem

sodium oxybate

Cataplexy Narcolepsy 2005-10-13           Authorised
Zerbaxa

ceftolozane sulfate / tazobactam sodium

Bacterial Infections 2015-09-18           Authorised
Zoledronic Acid Hospira

zoledronic acid monohydrate

Hypercalcemia 2012-11-19           Authorised
Rivastigmine Hexal

rivastigmine

Alzheimer Disease Dementia Parkinson Disease 2009-12-11           Authorised
Zoely

nomegestrol acetate / estradiol

Contraception 2011-07-27           Authorised
Tobi Podhaler

tobramycin

Cystic Fibrosis Respiratory Tract Infections 2011-07-20           Authorised
Ceplene

histamine dihydrochloride

Leukemia, Myeloid, Acute 2008-10-07           Authorised
Spinraza

nusinersen sodium

Muscular Atrophy, Spinal 2017-05-30           Authorised
Rasagiline Mylan

rasagiline tartrate

Parkinson Disease 2016-04-04           Authorised
Nevirapine Teva

nevirapine

HIV Infections 2009-11-30           Authorised