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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

telmisartan

Hypertension 2010-01-26           Authorised
Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)

clopidogrel / acetylsalicylic acid

Acute Coronary Syndrome Myocardial Infarction 2010-03-15           Authorised
Protopic

tacrolimus

Dermatitis, Atopic 2002-02-28           Authorised
Myfenax

mycophenolate mofetil

Graft Rejection 2008-02-21           Authorised
Vargatef

nintedanib

Carcinoma, Non-Small-Cell Lung 2014-11-21           Authorised
Edarbi

azilsartan medoxomil

Hypertension 2011-12-07           Authorised
Raloxifene Teva

raloxifene hydrochloride

Osteoporosis, Postmenopausal 2010-04-29           Authorised
Protelos

strontium ranelate

Osteoporosis, Postmenopausal 2004-09-21           Authorised
Matever

levetiracetam

Epilepsy 2011-10-03           Authorised
BeneFIX

nonacog alfa

Hemophilia B 1997-08-27           Authorised
Stelara

ustekinumab

Arthritis, Psoriatic Crohn Disease Psoriasis 2009-01-16           Authorised
Repaglinide Teva

repaglinide

Diabetes Mellitus, Type 2 2009-06-29           Authorised
Somac Control

pantoprazole

Gastroesophageal Reflux 2009-06-12           Authorised
Zostavax

varicella-zoster virus (live, attenuated)

Herpes Zoster Immunization 2006-05-19           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
Byetta

exenatide

Diabetes Mellitus, Type 2 2006-11-20           Authorised
Trobalt

retigabine

Epilepsy 2011-03-28           Authorised
Zyclara

imiquimod

Keratosis Keratosis, Actinic 2012-08-23           Authorised
Evoltra

clofarabine

Precursor Cell Lymphoblastic Leukemia-Lymphoma 2006-05-29           Authorised
Exelon

rivastigmine

Alzheimer Disease Dementia Parkinson Disease 1998-05-12           Authorised
Fertavid

follitropin beta

Hypogonadism Infertility 2009-03-19           Authorised
Levetiracetam Actavis Group

levetiracetam

Epilepsy 2011-12-05           Authorised
Brimica Genuair

aclidinium / formoterol fumarate dihydrate

Pulmonary Disease, Chronic Obstructive 2014-11-19           Authorised