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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

tofacitinib citrate

Arthritis, Rheumatoid 2017-03-22           Authorised
Duloxetine Mylan

duloxetine

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

galsulfase

Mucopolysaccharidosis VI 2006-01-24           Authorised
Palonosetron Hospira

palonosetron hydrochloride

Cancer Nausea Vomiting 2016-04-08           Authorised
Quadramet

samarium [153Sm] lexidronam pentasodium

Cancer Pain 1998-02-05           Authorised
Irbesartan/Hydrochlorothiazide Teva

irbesartan / hydrochlorothiazide

Hypertension 2009-11-26           Authorised
Omidria

ketorolac / phenylephrine

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

telmisartan

Hypertension 2010-06-04           Authorised
Ketoconazole HRA

ketoconazole

Cushing Syndrome 2014-11-19           Authorised
Onbrez Breezhaler

indacaterol maleate

Pulmonary Disease, Chronic Obstructive 2009-11-30           Authorised
Memantine Accord

memantine hydrochloride

Alzheimer Disease 2013-12-04           Authorised
Adrovance

alendronate sodium trihydrate / colecalciferol

Osteoporosis, Postmenopausal 2007-01-04           Authorised
Benlysta

belimumab

Lupus Erythematosus, Systemic 2011-07-13           Authorised
Scenesse

afamelanotide

Protoporphyria, Erythropoietic 2014-12-22           Authorised
Brilique

ticagrelor

Acute Coronary Syndrome Peripheral Vascular Diseases 2010-12-03           Authorised
Enzepi

pancreas powder

Exocrine Pancreatic Insufficiency 2016-06-29           Authorised
Vaniqa

eflornithine

Hirsutism 2001-03-20           Authorised
Myozyme

alglucosidase alfa

Glycogen Storage Disease Type II 2006-03-29           Authorised
Luveris

lutropin alfa

Infertility, Female Ovulation Induction 2000-11-29           Authorised
Topotecan Actavis

topotecan

Small Cell Lung Carcinoma Uterine Cervical Neoplasms 2009-07-24           Authorised
Topotecan Hospira

topotecan

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

alitretinoin

Sarcoma, Kaposi 2000-10-11           Authorised
Brimica Genuair

aclidinium / formoterol fumarate dihydrate

Pulmonary Disease, Chronic Obstructive 2014-11-19           Authorised
Aerivio Spiromax

salmeterol xinafoate / fluticasone propionate

Asthma Pulmonary Disease, Chronic Obstructive 2016-08-18           Authorised
Ketek

telithromycin

Bronchitis, Chronic Community-Acquired Infections Pharyngitis Pneumonia, Bacterial Sinusitis Tonsillitis 2001-07-09           Authorised