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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

simoctocog alfa

Hemophilia A 2017-02-13           Authorised
Xtandi

enzalutamide

Prostatic Neoplasms 2013-06-21           Authorised
Temozolomide Sun

temozolomide

Glioblastoma Glioma 2011-07-13           Authorised
Pregabalin Zentiva

pregabalin

Anxiety Disorders Epilepsy 2015-07-17           Authorised
Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)

irbesartan / hydrochlorothiazide

Hypertension 2007-01-19           Authorised
Mozobil

plerixafor

Hematopoietic Stem Cell Transplantation Lymphoma Multiple Myeloma 2009-07-31           Authorised
Cuprymina

copper (64Cu) chloride

Radionuclide Imaging 2012-08-23           Authorised
Privigen

human normal immunoglobulin (IVIg)

Bone Marrow Transplantation Guillain-Barre Syndrome Immunologic Deficiency Syndromes Mucocutaneous Lymph Node Syndrome Purpura, Thrombocytopenic, Idiopathic 2008-04-25           Authorised
Velphoro

mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches

Hyperphosphatemia Renal Dialysis 2014-08-26           Authorised
Vyndaqel

tafamidis

Amyloidosis 2011-11-16           Authorised
Stalevo

levodopa / carbidopa / entacapone

Parkinson Disease 2003-10-17           Authorised
Ifirmacombi

irbesartan / hydrochlorothiazide

Hypertension 2011-03-04           Authorised
Tarceva

erlotinib

Carcinoma, Non-Small-Cell Lung Pancreatic Neoplasms 2005-09-19           Authorised
Pioglitazone Accord

pioglitazone hydrochloride

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

rivastigmine

Alzheimer Disease Dementia Parkinson Disease 2009-05-11           Authorised
Starlix

nateglinide

Diabetes Mellitus, Type 2 2001-04-03           Authorised
Prevenar

pneumococcal polysaccharide serotype 4 / pneumococcal polysaccharide serotype 6B / pneumococcal polysaccharide serotype 9V / pneumococcal polysaccharide serotype 14 / pneumococcal oligosaccharide serotype 18C / pneumococcal polysaccharide serotype 19F / pneumococcal polysaccharide serotype 23F

Immunization Pneumococcal Infections 2001-02-02           Authorised
Optruma

raloxifene hydrochloride

Osteoporosis, Postmenopausal 1998-08-05           Authorised
Cyanokit

hydroxocobalamin

Poisoning 2007-11-23           Authorised
Rapilysin

reteplase

Myocardial Infarction 1996-08-29           Authorised
Kineret

anakinra

Arthritis, Rheumatoid 2002-03-08           Authorised
Actraphane

insulin human

Diabetes Mellitus 2002-10-07           Authorised
Ytracis

yttrium [90Y] chloride

Radionuclide Imaging 2003-03-24           Authorised
Tepadina

thiotepa

Hematopoietic Stem Cell Transplantation 2010-03-15           Authorised
Fycompa

perampanel

Epilepsies, Partial 2012-07-23           Authorised