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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

afamelanotide

Protoporphyria, Erythropoietic 2014-12-22           Authorised
Brilique

ticagrelor

Acute Coronary Syndrome Peripheral Vascular Diseases 2010-12-03           Authorised
Vaniqa

eflornithine

Hirsutism 2001-03-20           Authorised
Levetiracetam ratiopharm

levetiracetam

Epilepsy 2011-08-26           Authorised
Topotecan Actavis

topotecan

Small Cell Lung Carcinoma Uterine Cervical Neoplasms 2009-07-24           Authorised
Eylea

aflibercept

Diabetes Complications Macular Edema Wet Macular Degeneration 2012-11-22           Authorised
Topotecan Hospira

topotecan

Small Cell Lung Carcinoma Uterine Cervical Neoplasms 2010-06-10           Authorised
Panretin

alitretinoin

Sarcoma, Kaposi 2000-10-11           Authorised
Miglustat Gen.Orph

miglustat

Gaucher Disease 2017-11-10           Authorised
Ketek

telithromycin

Bronchitis, Chronic Community-Acquired Infections Pharyngitis Pneumonia, Bacterial Sinusitis Tonsillitis 2001-07-09           Authorised
Tafinlar

dabrafenib mesylate

Melanoma 2013-08-26           Authorised
Advagraf

tacrolimus

Graft Rejection 2007-04-23           Authorised
Litak

cladribine

Leukemia, Hairy Cell 2004-04-14           Authorised
Episalvan

betulae cortex dry extract  (5-10 : 1); extraction solvent: n-heptane 95% (w/w)

Wound Healing Wounds and Injuries 2016-01-14           Authorised
Ifirmasta (previously Irbesartan Krka)

irbesartan hydrochloride

Hypertension 2008-12-01           Authorised
Karvezide

irbesartan / hydrochlorothiazide

Hypertension 1998-10-16           Authorised
Silodyx

silodosin

Prostatic Hyperplasia 2010-01-29           Authorised
Epoetin Alfa Hexal

epoetin alfa

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

lapatinib

Breast Neoplasms 2008-06-10           Authorised
Busulfan Fresenius Kabi

busulfan

Hematopoietic Stem Cell Transplantation 2014-09-22           Authorised
NovoThirteen

catridecacog

Blood Coagulation Disorders, Inherited 2012-09-03           Authorised
Tovanor Breezhaler

glycopyrronium bromide

Pulmonary Disease, Chronic Obstructive 2012-09-28           Authorised
Avamys

fluticasone furoate

Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal 2008-01-11           Authorised
Lysodren

mitotane

Adrenal Cortex Neoplasms 2004-04-28           Authorised
Helicobacter Test INFAI

13C-urea

Breath Tests Helicobacter Infections 1997-08-14           Authorised