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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

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
Venclyxto

venetoclax

Leukemia, Lymphocytic, Chronic, B-Cell 2016-12-05           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
Constella

linaclotide

Irritable Bowel Syndrome 2012-11-26           Authorised
Daptomycin Hospira

daptomycin

Skin Diseases, Bacterial Soft Tissue Infections 2017-03-22           Authorised
Cymbalta

duloxetine

Anxiety Disorders Depressive Disorder, Major Diabetic Neuropathies 2004-12-17           Authorised
Memantine Mylan

memantine hydrochloride

Alzheimer Disease 2013-04-22           Authorised
Sivextro

tedizolid phosphate

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

insulin human

Diabetes Mellitus 1997-02-21           Authorised
Yentreve

duloxetine hydrochloride

Urinary Incontinence, Stress 2004-08-11           Authorised
Imvanex

modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus

Smallpox 2013-07-31           Authorised
Zavesca

miglustat

Gaucher Disease Niemann-Pick Diseases 2002-11-20           Authorised
Ribavirin Mylan (previously Ribavirin Three Rivers)

ribavirin

Hepatitis C, Chronic 2010-06-10           Authorised
Ibandronic Acid Teva

ibandronic acid

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

ataluren

Muscular Dystrophy, Duchenne 2014-07-31           Authorised
Opdivo

nivolumab

Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Hodgkin Disease Melanoma 2015-06-19           Authorised
Odefsey

emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide

HIV Infections 2016-06-21           Authorised
Evoltra

clofarabine

Precursor Cell Lymphoblastic Leukemia-Lymphoma 2006-05-29           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
Sutent

sunitinib

Carcinoma, Renal Cell Gastrointestinal Stromal Tumors Neuroendocrine Tumors 2006-07-19           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
Firmagon

degarelix

Prostatic Neoplasms 2009-02-17           Authorised
Hycamtin

topotecan

Ovarian Neoplasms Small Cell Lung Carcinoma Uterine Cervical Neoplasms 1996-11-12           Authorised
Zoledronic acid Teva Pharma

zoledronic acid

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