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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.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

prasugrel besilate

Acute Coronary Syndrome Angina, Unstable Myocardial Infarction 2018-05-16           Authorised
Juluca

 dolutegravir sodium,rilpivirine hydrochloride

HIV Infections 2018-05-16           Authorised
Trydonis

beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium

Pulmonary Disease, Chronic Obstructive 2018-04-26           Authorised
Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)

beclometasone dipropionate anhydrous / formoterol fumarate dihydrate / glycopyrronium

Pulmonary Disease, Chronic Obstructive 2018-04-23           Authorised
Mylotarg

gemtuzumab ozogamicin

Leukemia, Myeloid, Acute 2018-04-19           Authorised
Alpivab

peramivir

Influenza, Human 2018-04-13           Authorised
Semglee

insulin glargine

Diabetes Mellitus, Type 2 2018-03-23           Authorised
Lamzede

velmanase alfa

alpha-Mannosidosis 2018-03-23           Authorised
Steglujan

ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate

Diabetes Mellitus, Type 2 2018-03-23           Authorised
Segluromet

ertugliflozin l-pyroglutamic acid / metformin hydrochloride

Diabetes Mellitus, Type 2 2018-03-23           Authorised
Alofisel

darvadstrocel

Rectal Fistula 2018-03-23           Authorised
Lokelma

sodium zirconium cyclosilicate

Hyperkalemia 2018-03-22           Authorised
Shingrix

Varicella Zoster Virus glycoprotein E antigen

Herpes Zoster 2018-03-21           Authorised
Steglatro

ertugliflozin l-pyroglutamic acid

Diabetes Mellitus, Type 2 2018-03-21           Authorised
Hemlibra

emicizumab

Hemophilia A 2018-02-23           Authorised
Crysvita

burosumab

Hypophosphatemia, Familial Hypophosphatemic Rickets, X-Linked Dominant 2018-02-19           Authorised
Anagrelide Mylan

anagrelide hydrochloride

Thrombocythemia, Essential 2018-02-15           Authorised
Alkindi

hydrocortisone

Adrenal Insufficiency 2018-02-09           Authorised
Herzuma

trastuzumab

Breast Neoplasms Stomach Neoplasms 2018-02-09           Authorised
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

efavirenz / emtricitabine / tenofovir disoproxil succinate

HIV Infections 2018-02-08           Authorised
Ozempic

semaglutide

Diabetes Mellitus 2018-02-08           Authorised
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
Adynovi

rurioctocog alfa pegol

Hemophilia A 2018-01-08           Authorised