Tag: EMA

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
EMA protects public and animal health in 28 EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.
EMA serves a market of over 500 million people living in the EU.

Conclusions of EMA CVMP Meeting from 16-18 July

european medicines agency
CVMP concludes referral procedure and recommends suspension of veterinary medicines containing paromomycin to be administered parenterally to pigs CVMP opinions on veterinary medicinal products  ...

Janssen Announced Submission of Extension Application to EMA for DARZALEX®

janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of an extension application to the European Medicines Agency (EMA) for subcutaneous (under the skin) use of DARZA...

EMA’s PRAC 8-11 July 2019 Meeting Highlights

EMA’s safety committee (PRAC) has started a review of medicines containing cyproterone, which are used for treating a range of conditions, including excessive hair growth, prostate cancer and acne, as...

EMA’s PRAC Announced Measures to Avoid Dosing Errors

european medicines agency
EMA’s safety committee (PRAC) is recommending new measures to avoid dosing errors that have led to some patients incorrectly taking methotrexate-containing medicines daily instead of weekly. The ne...

Guido Rasi Elected as EMA’s Executive Director

The International Coalition of Medicines Regulatory Authorities (ICMRA) has elected EMA’s Executive Director Guido Rasi as its new chair.  ICMRA brings together the leaders of regulatory authoritie...

EU Network Takes Steps to Resolve Medicines Shortages

european medicines agency
The European Union task force set up to address problems with medicines supply has published two documents today: guidance for marketing authorisation holders on reporting of shortages in the EU ...

EC and EMA Call for Sponsors to Publish Clinical Trial Results in EU Database

research
The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European ...

EMA Recommended Three New Medicines for Approval

EMA’s human medicines committee (CHMP) recommended three medicines for approval at its June 2019 meeting. The Committee recommended granting a marketing authorisation for Giapreza (angiotensin II),...

EMA to Review MAA for First China-Developed Trastuzumab Biosimilar

First trastuzumab developed in China following the National Medical Products Administration (NMPA) technical guideline for biosimilar with the New Drug Application (NDA) received the acceptance for re...

CHMP Recommends Treatment for Paediatric Type 2 Diabetes

EMA’s human medicines committee (CHMP) has recommended granting an extension of indication to Victoza (liraglutide) to include the treatment of children and adolescents aged 10 years or older with typ...

Amgen Update on Status of EVENITY™ in the EU

Amgen and UCB announced that the companies have been informed the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Mar...

Bayer’s Vet Med Received Positive Opinion for New Indications

Bayer's broadly active endectocide Advocate® Spot-on (imidacloprid/moxidectin) has now received, by consensus, the positive Opinion of the Committee for Medicinal Products for Veterinary Use (CVMP) of...

EMA Validated Santhera’s Application for Puldysa

Santhera Pharmaceuticals announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for Puldysa® (idebenone) in the treatment of respiratory dysfunc...

New CVMP Meeting Was Held on 18-20 June

Committee for Medicinal Products for Veterinary Use (CVMP) meeting took place on 18-20 June 2019. The Committee elected Gerrit Johan Schefferlie from the Netherlands as the CVMP vice-chair for a 3-...

EMA’s PRAC Starts Review of Leuprorelin Medicines

EMA’s safety committee (PRAC) has started a review of leuprorelin medicines after reports indicated that handling errors during preparation and administration can cause some patients to receive insuff...

EMA Strengthens Cooperation with General Practitioners

EMA and the two major organisations representing general practitioners (GPs) and family physicians in Europe – the European Union of General Practitioners (UEMO) and the European section of the World ...