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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

cetrorelix

Ovulation Ovulation Induction 1999-04-13           Authorised
Tolucombi

telmisartan / hydrochlorothiazide

Hypertension 2013-03-13           Authorised
Comtan

entacapone

Parkinson Disease 1998-09-22           Authorised
Inlyta

axitinib

Carcinoma, Renal Cell 2012-09-03           Authorised
Topotecan Teva

topotecan

Ovarian Neoplasms Small Cell Lung Carcinoma Uterine Cervical Neoplasms 2009-09-21           Authorised
Ucedane

carglumic acid

Amino Acid Metabolism, Inborn Errors Hyperammonemia 2017-06-23           Authorised
Jetrea

ocriplasmin

Retinal Diseases 2013-03-13           Authorised
Temozolomide Sun

temozolomide

Glioblastoma Glioma 2011-07-13           Authorised
Atosiban SUN

atosiban acetate

Premature Birth 2013-07-31           Authorised
Edarbi

azilsartan medoxomil

Hypertension 2011-12-07           Authorised
Sycrest

asenapine maleate 

Bipolar Disorder 2010-09-01           Authorised
Conbriza

bazedoxifene

Osteoporosis, Postmenopausal 2009-04-17           Authorised
Ristempa

pegfilgrastim

Neutropenia 2015-04-13           Authorised
Glustin

pioglitazone hydrochloride

Diabetes Mellitus, Type 2 2000-10-11           Authorised
Entacapone Orion

entacapone

Parkinson Disease 2011-08-18           Authorised
Vosevi

sofosbuvir / velpatasvir / voxilaprevi

Hepatitis C, Chronic 2017-07-26           Authorised
Suliqua

insulin glargine / lixisenatide

Diabetes Mellitus, Type 2 2017-01-11           Authorised
Ionsys

fentanyl hydrochloride

Pain, Postoperative 2015-11-19           Authorised
Glyxambi

empagliflozin / linagliptin

Diabetes Mellitus, Type 2 2016-11-11           Authorised
Duloxetine Mylan

duloxetine

Anxiety Disorders Depressive Disorder, Major Diabetic Neuropathies Neuralgia 2015-06-19           Authorised
Naglazyme

galsulfase

Mucopolysaccharidosis VI 2006-01-24           Authorised
Quadramet

samarium [153Sm] lexidronam pentasodium

Cancer Pain 1998-02-05           Authorised
Omidria

ketorolac / phenylephrine

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

telmisartan

Hypertension 2010-06-04           Authorised
Adrovance

alendronate sodium trihydrate / colecalciferol

Osteoporosis, Postmenopausal 2007-01-04           Authorised