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 Agreed to Review Marketing Application for Amarin’s Vascepa

The European Medicines Agency (EMA) has agreed to review its marketing application for Amarin’s cardiovascular (CV) drug, Vascepa (icosapent ethyl). The regulatory organisation says that it is expe...

Bayer Submitted Application to EMA to Extend Xarelto Marketing Authorization

Bayer has submitted an application to the European Medicines Agency (EMA) to extend the Xarelto marketing authorization, making it available for children up to 17 years old with confirmed VTE, includi...

New Building Handed Over to EMA by Dutch Authorities

The Dutch authorities have handed over to EMA its newly built tailor-made premises, located in the Zuidas area of Amsterdam. Guido Rasi, EMA’s Executive Director, signed the lease agreement and thanke...

EMA Recommended Seven New Medicines for Approval

EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its November 2019 meeting. The Committee recommended granting a marketing authorisation for Isturisa* (osilodrosta...

EMA Announced that Xeljanz Could Increase Risks of Blood Clots

EMA has concluded that Xeljanz (tofacitinib) could increase the risk of blood clots in the lungs and in deep veins in patients who are already at high risk. As a result, the Agency is recommending ...

EMA Issued Guideline on New Urate-Lowering Therapies

The European Medicines Agency (EMA) issued a guideline setting its expectations for the clinical development of new urate-lowering therapies (ULT) and anti-inflammatory drugs to treat gout. The 14-...

Access to Highly Innovative Therapies Can be Broadened by Regulators’ Advice

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Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies (HTAs) and patients can play a key role in delivering robust data needed to enable...

CVMP Recommended Two New Veterinary Medicines for MUMS/Limited Markets

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The Committee adopted by majority a positive opinion for an initial marketing authorisation application for Stelfonta (tigilanol tiglate), from QBiotics Netherlands B.V., a new product for the treatme...

Janssen Submitted Application to EMA for Investigational Ebola Vaccine Regimen Authorisation

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Johnson & Johnson announced that its Janssen Pharmaceutical Companies have submitted Marketing Authorisation Applications (MAAs) to the European Medicines Agency (EMA) seeking licensure for an inv...

EMA Validated for Review Pierre Fabre Application for BRAFTOVI®

Pierre Fabre announced that the European Medicines Agency (EMA) has validated for review the filing of Type II variation applications for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in combinatio...

EMA’s PRAC Recommended Restricting Lemtrada to Minimise Risk of Serious Side Effects

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PRAC recommends measures to minimize the risk of serious side effects with Lemtrada for multiple sclerosis. EMA’s safety committee (PRAC) recommended restricting Lemtrada for use in adults with rel...

STA Pharma Manufacturing Facility in Shanghai Passed EMA Inspection

STA Pharmaceutical Co., Ltd. – a subsidiary of WuXi AppTec – announced that its Jinshan manufacturing facility in Shanghai, China has successfully passed an inspection by the European Medicines Agency...

EMA and FDA Accepted for Review Roche’s Marketing Applications for Satralizumab

Roche announced that the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application for satralizumab for the treatment of adult and adolescent patients with neurom...

EMA Urges Companies to Submit Type I Variations for 2019 by End of November 2019

The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IAIN variations for 2019 no later than Friday 29 November 2019. This will enable EMA to ackno...

EMA Showed Plan for Supporting Alternatives to Antimicrobials

european medicines agency
The EMA Committee for Medicinal Products for Veterinary Use (CVMP) has published a reflection paper on ways to promote authorization of alternatives to antimicrobials. CVMP used the reflection paper t...

EMA Developed Guidance on Strengthening Decision-Making in Healthcare

european medicines agency
EMA’s human medicines committee (CHMP) has developed a paper to strengthen consistency when defining therapeutic indications in the product information of medicines. The document is intended to gui...