European public assessment reports

  • Email
  • Help

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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

Document status

Include:

Browse by letter

Browse by letter for medicines that have a European Public Assessment Report:

Or for other types of content pick from the navigation on the left.

Search by keyword

Search for keyword:

Search by therapeutic area

Browse the database based on therapeutic area:

/

Browse by type

Browse by type:

Download results to spreadsheet
EPAR Search results
Name Active substance Therapeutic area Date of authorisation / refusal Additional monitoring Orphan     Has current safety alert Status
Ribavirin Mylan (previously Ribavirin Three Rivers)

ribavirin

Hepatitis C, Chronic 2010-06-10           Authorised
Copalia

amlodipine (as besylate) / valsartan

Hypertension 2007-01-16           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
Levemir

insulin detemir

Diabetes Mellitus 2004-06-01           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
Deltyba

delamanid

Tuberculosis, Multidrug-Resistant 2014-04-28           Authorised
Revinty Ellipta

fluticasone furoate / vilanterol trifenatate

Asthma 2014-05-02           Authorised
Fasenra

benralizumab

Asthma 2018-01-08           Authorised
Zoledronic acid Teva Pharma

zoledronic acid

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

fentanyl

Cancer Pain 2010-08-31           Authorised
Suboxone

buprenorphine / naloxone

Opioid-Related Disorders 2006-09-26           Authorised
Fortacin

lidocaine / prilocaine

Sexual Dysfunction, Physiological 2013-11-15           Authorised
Telmisartan Teva Pharma

telmisartan

Hypertension 2011-10-03           Authorised
Emadine

emedastine

Conjunctivitis, Allergic 1999-01-27           Authorised
Kogenate Bayer

octocog alfa

Hemophilia A 2000-08-04           Authorised
Cholestagel

colesevelam

Hypercholesterolemia 2004-03-10           Authorised
Vantobra

tobramycin

Cystic Fibrosis Respiratory Tract Infections 2015-03-18           Authorised
Levetiracetam Teva

levetiracetam

Epilepsy 2011-08-26           Authorised
Viagra

sildenafil

Erectile Dysfunction 1998-09-14           Authorised
Fexeric

ferric citrate coordination complex

Hyperphosphatemia Renal Dialysis 2015-09-23           Authorised
Aubagio

teriflunomide

Multiple Sclerosis 2013-08-26           Authorised
MicardisPlus

telmisartan / hydrochlorothiazide

Hypertension 2002-04-19           Authorised