Tag: EMA

Janssen Submitted Application to EMA for Investigational Ebola Vaccine Regimen Authorisation

ebola-virus
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

ema
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...

EMA Recommended Seven New Medicines for Approval

european medicines agency
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its October 2019 meeting. The Committee recommended granting conditional marketing authorisation for Ervebo (Ebola...

UCB and Amgen EVENITY® Received Positive CHMP Opinion

UCB and Amgen announced that following a re-examination procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion reco...

EMA Requests Risk Evaluation for Drugs Containing Chemically Synthesised APIs

api
EMA published a statement titled “EMA advises companies on steps to take to avoid nitrosamines in human medicines (EMA/511347/2019)”. This document addresses all marketing authorisations holders for d...

Bayer’s Otic Solution Neptra® Received Positive Opinion of EMA’s CVMP

Bayer's Otic Solution Neptra® (florfenicol, terbinafine hydrochloride, mometasone furoate) has now received, the positive opinion of the Committee for Medicinal Products for Veterinary Use (CVMP) of t...

CVMP Recommended Two New Veterinary Medicines for Companion Animals

european medicines agency
The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for Neptra, from Bayer Animal Health GmbH, a new product for the treatment of canine otitis ext...

Highlights of EMA Management Board Meeting

At its 3 October 2019 meeting in Amsterdam, the European Medicines Agency's Management Board elected Lorraine Nolan as vice-chair of the Board for a three-year period. Dr Nolan is Chief Executive of t...

PRAC Recommended Limiting Use of High-Strength Creams to 4 Weeks

EMA
EMA’s safety committee (PRAC) has recommended limiting the use of high-strength creams containing 100 micrograms/gram (0.01%) of estradiol to a single treatment period of up to 4 weeks. This measure i...

EMA Requested to Change Names of Liposomal Medicines at High Risk of Medication Errors

pills
Marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit a variation to change the names of liposomal medicines, but only if there is a high risk...