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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

temsirolimus

Carcinoma, Renal Cell Lymphoma, Mantle-Cell 2007-11-19           Authorised
Signifor

pasireotide

Acromegaly Pituitary ACTH Hypersecretion 2012-04-24           Authorised
Trimbow

beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium bromide

Pulmonary Disease, Chronic Obstructive 2017-07-17           Authorised
Irbesartan Teva

irbesartan

Hypertension 2009-10-30           Authorised
Pravafenix

fenofibrate / pravastatin

Dyslipidemias 2011-04-14           Authorised
Topotecan Hospira

topotecan

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

atosiban acetate

Premature Birth 2000-01-20           Authorised
Miglustat Gen.Orph

miglustat

Gaucher Disease 2017-11-10           Authorised
Yondelis

trabectedin

Ovarian Neoplasms Sarcoma 2007-09-17           Authorised
Cancidas (previously Caspofungin MSD)

caspofungin

Aspergillosis Candidiasis 2001-10-24           Authorised
Efficib

sitagliptin / metformin hydrochloride

Diabetes Mellitus, Type 2 2008-07-16           Authorised
Vipdomet

alogliptin benzoate / metformin hydrochloride

Diabetes Mellitus, Type 2 2013-09-19           Authorised
Integrilin

eptifibatide

Angina, Unstable Myocardial Infarction 1999-07-01           Authorised
Lonquex

lipegfilgrastim

Neutropenia 2013-07-25           Authorised
Duloxetine Lilly

duloxetine

Diabetic Neuropathies Neuralgia 2014-12-08           Authorised
Valdoxan

agomelatine

Depressive Disorder, Major 2009-02-19           Authorised
Zerit

stavudine

HIV Infections 1996-05-08           Authorised
Ikervis

ciclosporin

Corneal Diseases 2015-03-19           Authorised
Ammonaps

sodium phenylbutyrate

Carbamoyl-Phosphate Synthase I Deficiency Disease Citrullinemia Ornithine Carbamoyltransferase Deficiency Disease 1999-12-08           Authorised
Capecitabine Accord

capecitabine

Breast Neoplasms Colonic Neoplasms Colorectal Neoplasms Stomach Neoplasms 2012-04-20           Authorised
Revestive

teduglutide

Malabsorption Syndromes 2012-08-30           Authorised
Jentadueto

linagliptin / metformin

Diabetes Mellitus, Type 2 2012-07-20           Authorised
DepoCyte

cytarabine

Meningeal Neoplasms 2001-07-11           Authorised
Lumark

lutetium, isotope of mass 177

Radionuclide Imaging 2015-06-19           Authorised