European public assessment reports

  • Email
  • Help

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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

Document status

Include:

Browse by letter

Browse by letter for medicines that have a European Public Assessment Report:

Or for other types of content pick from the navigation on the left.

Search by keyword

Search for keyword:

Search by therapeutic area

Browse the database based on therapeutic area:

/

Browse by type

Browse by type:

Download results to spreadsheet
EPAR Search results
Name Active substance Therapeutic area Date of authorisation / refusal Additional monitoring Orphan     Has current safety alert Status
Ivabradine Anpharm

ivabradine

Angina Pectoris 2015-09-08           Authorised
Ibandronic Acid Sandoz

ibandronic acid

Breast Neoplasms Fractures, Bone Neoplasm Metastasis 2011-07-26           Authorised
Torisel

temsirolimus

Carcinoma, Renal Cell Lymphoma, Mantle-Cell 2007-11-19           Authorised
Pemetrexed Hospira UK Limited

pemetrexed ditromethamine

Carcinoma, Non-Small-Cell Lung Mesothelioma 2017-04-24           Authorised
Protopic

tacrolimus

Dermatitis, Atopic 2002-02-28           Authorised
Olumiant

baricitinib

Arthritis, Rheumatoid 2017-02-13           Authorised
Stocrin

efavirenz

HIV Infections 1999-05-28           Authorised
Oprymea

pramipexole dihydrochloride monohydrate

Parkinson Disease 2008-09-12           Authorised
Myfenax

mycophenolate mofetil

Graft Rejection 2008-02-21           Authorised
Scintimun

besilesomab

Osteomyelitis Radionuclide Imaging 2010-01-11           Authorised
Evista

raloxifene hydrochloride

Osteoporosis, Postmenopausal 1998-08-05           Authorised
Mircera

methoxy polyethylene glycol-epoetin beta

Anemia Kidney Failure, Chronic 2007-07-20           Authorised
Envarsus

tacrolimus

Graft Rejection 2014-07-18           Authorised
Olazax Disperzi

olanzapine

Bipolar Disorder Schizophrenia 2009-12-10           Authorised
M-M-RVaxPro

measles virus Enders’ Edmonston strain (live, attenuated) / mumps virus Jeryl Lynn (level B) strain (live, attenuated) / rubella virus Wistar RA 27/3 strain (live, attenuated)

Immunization Measles Mumps Rubella 2006-05-05           Authorised
Evicel

human fibrinogen / human thrombin

Hemostasis, Surgical 2008-10-06           Authorised
Firazyr

icatibant

Angioedemas, Hereditary 2008-07-11           Authorised
Diacomit

stiripentol

Myoclonic Epilepsy, Juvenile 2007-01-04           Authorised
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)

telmisartan

Hypertension 1998-12-16           Authorised
Levetiracetam Hospira

levetiracetam

Epilepsy 2014-01-08           Authorised
Instanyl

fentanyl citrate

Cancer Pain 2009-07-20           Authorised
Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)

split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)

Disease Outbreaks Immunization Influenza, Human 2009-10-10           Authorised
NutropinAq

somatropin

Dwarfism, Pituitary Turner Syndrome 2001-02-16           Authorised
Sildenafil ratiopharm

sildenafil

Erectile Dysfunction 2009-12-23           Authorised
Menveo

meningococcal group A, C, W-135 and Y conjugate vaccine

Immunization Meningitis, Meningococcal 2010-03-15           Authorised