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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

telithromycin

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

lamivudine / zidovudine

HIV Infections 1998-03-18           Authorised
Yervoy

ipilimumab

Melanoma 2011-07-13           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
Otezla

apremilast

Arthritis, Psoriatic Psoriasis 2015-01-15           Authorised
Silodyx

silodosin

Prostatic Hyperplasia 2010-01-29           Authorised
Epoetin Alfa Hexal

epoetin alfa

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

catridecacog

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

glycopyrronium bromide

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

mitotane

Adrenal Cortex Neoplasms 2004-04-28           Authorised
Abasaglar (previously Abasria)

insulin glargine

Diabetes Mellitus 2014-09-09           Authorised
Volibris

ambrisentan

Hypertension, Pulmonary 2008-04-21           Authorised
Ryzodeg

insulin aspart / insulin degludec

Diabetes Mellitus 2013-01-21           Authorised
Micardis

telmisartan

Hypertension 1998-12-16           Authorised
Vihuma

simoctocog alfa

Hemophilia A 2017-02-13           Authorised
Galafold

migalastat hydrochloride

Fabry Disease 2016-05-26           Authorised
Omidria

ketorolac / phenylephrine

Lens Implantation, Intraocular Pain, Postoperative 2015-07-28           Authorised
Cometriq

cabozantinib

Thyroid Neoplasms 2014-03-21           Authorised
Alprolix

eftrenonacog alfa

Hemophilia B 2016-05-12           Authorised
Ruconest

recombinant human c1-inhibitor

Angioedemas, Hereditary 2010-10-28           Authorised
Pioglitazone Accord

pioglitazone hydrochloride

Diabetes Mellitus, Type 2 2012-03-21           Authorised
Zometa

zoledronic acid / zoledronic acid monohydrate

Cancer Fractures, Bone 2001-03-20           Authorised
Starlix

nateglinide

Diabetes Mellitus, Type 2 2001-04-03           Authorised
Mycophenolate mofetil Teva

mycophenolate mofetil

Graft Rejection 2008-02-21           Authorised