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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

insulin glargine

Diabetes Mellitus 2014-09-09           Authorised
Abilify

aripiprazole

Bipolar Disorder Schizophrenia 2004-06-04           Authorised
Abilify Maintena

aripiprazole

Schizophrenia 2013-11-15           Authorised
Ablavar (previously Vasovist)

gadofosveset trisodium

Magnetic Resonance Angiography 2005-10-03           Withdrawn
Abraxane

paclitaxel

Breast Neoplasms Carcinoma, Non-Small-Cell Lung Pancreatic Neoplasms 2008-01-11           Authorised
Abseamed

epoetin alfa

Anemia Cancer Kidney Failure, Chronic 2007-08-28           Authorised
Accofil

filgrastim

Neutropenia 2014-09-18           Authorised
Aclasta

zoledronic acid

Osteitis Deformans Osteoporosis Osteoporosis, Postmenopausal 2005-04-15           Authorised
Acomplia

rimonabant

Obesity 2006-06-19           Withdrawn
Acrescent

memantine hydrochloride / donepezil hydrochloride

Alzheimer Disease 2013-02-20           Refused
Actelsar HCT

telmisartan / hydrochlorothiazide

  2013-03-13           Authorised
Actos

pioglitazone hydrochloride

Diabetes Mellitus, Type 2 2000-10-13           Authorised
Actraphane

insulin human

Diabetes Mellitus 2002-10-07           Authorised
Actrapid

human insulin

Diabetes Mellitus 2002-10-07           Authorised
Adasuve

loxapine

Bipolar Disorder Schizophrenia 2013-02-20           Authorised
Adcetris

brentuximab vedotin

Hodgkin Disease Lymphoma, Non-Hodgkin 2012-10-25           Authorised
Adcirca (previously Tadalafil Lilly)

tadalafil

Hypertension, Pulmonary 2008-10-01           Authorised
Adempas

riociguat

Hypertension, Pulmonary 2014-03-27           Authorised
Adenuric

febuxostat

Gout 2008-04-21           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
Adrovance

alendronate sodium trihydrate / colecalciferol

Osteoporosis, Postmenopausal 2007-01-04           Authorised
Advagraf

tacrolimus

Graft Rejection 2007-04-23           Authorised
Advate

octocog alfa

Hemophilia A 2004-03-02           Authorised
Aerinaze

desloratadine / pseudophedrine sulphate

Rhinitis, Allergic, Seasonal 2007-07-30           Authorised
Aerius

desloratadine

Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Urticaria 2001-01-15           Authorised