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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

nusinersen sodium

Muscular Atrophy, Spinal 2017-05-30           Authorised
Rasagiline Mylan

rasagiline tartrate

Parkinson Disease 2016-04-04           Authorised
Deltyba

delamanid

Tuberculosis, Multidrug-Resistant 2014-04-28           Authorised
Nevirapine Teva

nevirapine

HIV Infections 2009-11-30           Authorised
Dukoral

recombinant cholera toxin B subunit / vibrio cholerae 01

Cholera Immunization 2004-04-28           Authorised
Rivastigmine Sandoz

rivastigmine

Alzheimer Disease Dementia Parkinson Disease 2009-12-11           Authorised
HyQvia

human normal immunoglobulin

Immunologic Deficiency Syndromes 2013-05-16           Authorised
Cymbalta

duloxetine

Anxiety Disorders Depressive Disorder, Major Diabetic Neuropathies 2004-12-17           Authorised
Levodopa/Carbidopa/Entacapone Orion

levodopa / carbidopa / entacapone

Parkinson Disease 2011-08-24           Authorised
Memantine Mylan

memantine hydrochloride

Alzheimer Disease 2013-04-22           Authorised
Sivextro

tedizolid phosphate

Skin Diseases, Bacterial Soft Tissue Infections 2015-03-23           Authorised
Movymia

teriparatide

Osteoporosis 2017-01-11           Authorised
Yentreve

duloxetine hydrochloride

Urinary Incontinence, Stress 2004-08-11           Authorised
Ribavirin Mylan (previously Ribavirin Three Rivers)

ribavirin

Hepatitis C, Chronic 2010-06-10           Authorised
Ionsys

fentanyl hydrochloride

Pain, Postoperative 2015-11-19           Authorised
Ibandronic Acid Teva

ibandronic acid

Breast Neoplasms Fractures, Bone Neoplasm Metastasis Osteoporosis, Postmenopausal 2010-09-17           Authorised
Reyataz

atazanavir sulphate

HIV Infections 2004-03-02           Authorised
Zalmoxis

Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)

Graft vs Host Disease Hematopoietic Stem Cell Transplantation 2016-08-18           Authorised
Erivedge

vismodegib

Carcinoma, Basal Cell 2013-07-12           Authorised
Firmagon

degarelix

Prostatic Neoplasms 2009-02-17           Authorised
Fasenra

benralizumab

Asthma 2018-01-08           Authorised
Zoledronic acid Teva Pharma

zoledronic acid

Osteitis Deformans Osteoporosis Osteoporosis, Postmenopausal 2012-08-16           Authorised
Tysabri

natalizumab

Multiple Sclerosis 2006-06-27           Authorised
Fortacin

lidocaine / prilocaine

Sexual Dysfunction, Physiological 2013-11-15           Authorised
Victrelis

boceprevir

Hepatitis C, Chronic 2011-07-18           Authorised