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.

EMA Restricted Use of Xeljanz Due to the Risk of Blood Clots in Lungs

EMA’s safety committee (PRAC) is recommending that doctors must not prescribe the 10 mg twice daily dose of Xeljanz (tofacitinib) in patients who are at high risk of blood clots in the lungs. These in...

EMA Withdrawn Marketing Authorisations for Fenspiride Medicines

EMA’s safety committee (PRAC) has recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU. This follows a review that ha...

EMA Launches Social Media Campaign on Medicines Regulation in EU

EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines available in Europe safe and effective. As of today, EMA will start sharing a series of ...

EMA Published Annual Report

The annual report published today provides an overview of the Agency’s activities to protect and promote the health of people and animals in the EU and highlights EMA’s most significant achievements i...

EMA Recommended Thirteen Medicines for Approval

EMA’s human medicines committee (CHMP) recommended thirteen medicines for approval at its April 2019 meeting. The Committee recommended granting a marketing authorisation for Sixmo (buprenorphine) ...

EMA Has Started a Review of The Multiple Sclerosis Medicine Lemtrada

EMA has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of immune-mediated conditions (caused by the body’s defence system not working properly) and pr...

Two Celgene Meds Received CHMP Positive Opinion

Celgene Corporation, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for two triplet regimens based on Celgene’...

EMA Issued EU Recommendations for Influenza Season

EMA has issued the EU recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2019. Manufacturers ...

Q&A for Mutual Agreement of FDA and EMA

The EMA has published a new Questions and Answers (Q&A) document on the Mutual Recognition Agreement (MRA) between the EU and the FDA. On March 2, 2017 the US FDA and EU (EMA) announced that a ...

EMA Published Q&A for Brexit

EMA has published a questions-and-answers (Q&A) document for patients, healthcare professionals and the general public on the preparatory work that European Union authorities are doing to prevent ...

Improved EudraVigilance Receives More Reports

The new and improved EudraVigilance, the European system for managing and analysing information on suspected adverse reactions to medicines that are authorised or being studied in clinical trials in t...

EMA Recommended Marketing of Bayer’s Suspension for Piglets

The Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency has, by consensus, adopted a positive opinion recommending marketing authorisation for the veterinary me...

Boehringer Ingelheim Seeks Approval of FDA and EMA for SSc-ILD Drug

Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA. Nintedanib as an anti-fibr...

EMA Started to Operate in Amsterdam

As of today, EMA is operating from Amsterdam. EMA left its London premises on 1 March, and following a transitional week of teleworking, its staff will gradually move throughout this week into the Spa...

Celgene Submitted MAA for Ozanimod

Celgene Corporation today announced that the Company has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for ozanimod for the treatment of adults with relapsing-...

Bayer Submits MAA for nmCRPC Treatment

bayer
Bayer has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate ...