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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

nepafenac

Ophthalmologic Surgical Procedures Pain, Postoperative 2007-12-11           Authorised
Quadramet

samarium [153Sm] lexidronam pentasodium

Cancer Pain 1998-02-05           Authorised
Latuda

lurasidone

Schizophrenia 2014-03-21           Authorised
Hemlibra

emicizumab

Hemophilia A 2018-02-23           Authorised
Brilique

ticagrelor

Acute Coronary Syndrome Peripheral Vascular Diseases 2010-12-03           Authorised
Memantine LEK

memantine hydrochloride

Alzheimer Disease 2013-04-22           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
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
Ifirmasta (previously Irbesartan Krka)

irbesartan hydrochloride

Hypertension 2008-12-01           Authorised
Galafold

migalastat hydrochloride

Fabry Disease 2016-05-26           Authorised
Epoetin Alfa Hexal

epoetin alfa

Anemia Cancer Kidney Failure, Chronic 2007-08-28           Authorised
Xoterna Breezhaler

indacaterol / glycopyrronium bromide

Pulmonary Disease, Chronic Obstructive 2013-09-19           Authorised
NovoThirteen

catridecacog

Blood Coagulation Disorders, Inherited 2012-09-03           Authorised
Lysodren

mitotane

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

insulin glargine

Diabetes Mellitus 2014-09-09           Authorised
Micardis

telmisartan

Hypertension 1998-12-16           Authorised
Vihuma

simoctocog alfa

Hemophilia A 2017-02-13           Authorised
Omidria

ketorolac / phenylephrine

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

cabozantinib

Thyroid Neoplasms 2014-03-21           Authorised
Ruconest

recombinant human c1-inhibitor

Angioedemas, Hereditary 2010-10-28           Authorised
Oncaspar

pegaspargase

Precursor Cell Lymphoblastic Leukemia-Lymphoma 2016-01-14           Authorised
Pioglitazone Accord

pioglitazone hydrochloride

Diabetes Mellitus, Type 2 2012-03-21           Authorised