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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

darunavir

HIV Infections 2018-01-26           Authorised
Darunavir Krka d.d.

darunavir

HIV Infections 2018-01-18           Authorised
Mvasi

bevacizumab

Breast Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Fallopian Tube Neoplasms Ovarian Neoplasms Peritoneal Neoplasms 2018-01-15           Authorised
Ocrevus

ocrelizumab

Multiple Sclerosis 2018-01-08           Authorised
Fulvestrant Mylan

fulvestrant

Breast Neoplasms 2018-01-08           Authorised
Prevymis

letermovir

Cytomegalovirus Infections 2018-01-08           Authorised
Jorveza

budesonide

Esophageal Diseases 2018-01-08           Authorised
Adynovi

rurioctocog alfa pegol

Hemophilia A 2018-01-08           Authorised
Intrarosa

prasterone

Menopause 2018-01-08           Authorised
Tacforius

tacrolimus monohydrate

Kidney Transplantation Liver Transplantation 2017-12-08           Authorised
Zejula

niraparib tosylate monohydrate

Fallopian Tube Neoplasms Ovarian Neoplasms Peritoneal Neoplasms 2017-11-16           Authorised
Trelegy Ellipta

fluticasone furoate, umeclidinium bromide, vilanterol trifenatate

Pulmonary Disease, Chronic Obstructive 2017-11-15           Authorised
Ontruzant

trastuzumab

Breast Neoplasms Stomach Neoplasms 2017-11-15           Authorised
Elebrato Ellipta

fluticasone furoate / umeclidinium bromide / vilanterol trifenatate

Pulmonary Disease, Chronic Obstructive 2017-11-15           Authorised
Miglustat Gen.Orph

miglustat

Gaucher Disease 2017-11-10           Authorised
Cyltezo

adalimumab

Arthritis, Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Colitis, Ulcerative Crohn Disease Hidradenitis Suppurativa Psoriasis Spondylitis, Ankylosing Uveitis 2017-11-10           Authorised
Zubsolv

buprenorphine hydrochloride, naloxone hydrochloride dihydrate

Opioid-Related Disorders 2017-11-10           Authorised
Tremfya

guselkumab

Psoriasis 2017-11-10           Authorised
Ritonavir Mylan

ritonavir

HIV Infections 2017-11-10           Authorised
Tookad

padeliporfin di-potassium

Prostatic Neoplasms 2017-11-10           Authorised
VeraSeal

human fibrinogen, human thrombin

Hemostasis, Surgical 2017-11-10           Authorised
Nyxoid

naloxone hydrochloride dihydrate

Opioid-Related Disorders 2017-11-10           Authorised
Dupixent

dupilumab

Dermatitis, Atopic 2017-09-27           Authorised
Lutathera

lutetium (177Lu) oxodotreotide

Neuroendocrine Tumors 2017-09-26           Authorised
Entecavir Accord

entecavir

Hepatitis B, Chronic 2017-09-26           Authorised