News and press releases
Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 March 2019, CVMP, 22/03/2019
Fri, 22 Mar 2019 16:30 +0100
At its first meeting in Amsterdam CVMP adopts recommendations for two new initial marketing authorisations and one extension.CVMP opinions on veterinary...
EMA Management Board: highlights of March 2019 meeting, MB, 22/03/2019
Fri, 22 Mar 2019 13:40 +0100
EMA’s Management Board has re-elected Christa Wirthumer-Hoche as its chair for a three-year mandate. Dr Wirthumer-Hoche is Head of the Austrian Medicines...
Management Board re-elects Christa Wirthumer-Hoche as chair, , 21/03/2019
Thu, 21 Mar 2019 10:00 +0100
EMA’s Management Board today re-elected Christa Wirthumer-Hoche as its chair for a three-year mandate. Dr Wirthumer-Hoche is Head of the Austrian...
Increased risk of blood clots in lungs and death with higher dose of Xeljanz (tofacitinib) for rheumatoid arthritis, CHMP, 20/03/2019
Wed, 20 Mar 2019 14:00 +0100
EMA is advising healthcare professionals and patients not to exceed the recommended dose of Xeljanz (tofacitinib) when treating rheumatoid arthritis. The...
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019, PRAC, 15/03/2019
Fri, 15 Mar 2019 13:24 +0100
PRAC starts review on screening patients before treatment with fluorouracil, capecitabine, tegafur and flucytosine to decrease the risk of side...
EMA now operating from Amsterdam, , 11/03/2019
Mon, 11 Mar 2019 14:00 +0100
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...
Regulatory information – adjusted fees for applications to EMA from 1 April 2019, , 01/03/2019
Fri, 01 Mar 2019 16:05 +0100
The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for...
New add-on treatment to insulin for treatment of certain patients with type 1 diabetes, CHMP, 01/03/2019
Fri, 01 Mar 2019 12:03 +0100
EMA’s human medicines committee (CHMP) has adopted a positive opinion for Zynquista (sotagliflozin) intended as an adjunct to insulin for certain...
First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban, CHMP, 01/03/2019
Fri, 01 Mar 2019 12:02 +0100
EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Ondexxya (andexanet alfa...
CHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited metabolic disease, CHMP, 01/03/2019
Fri, 01 Mar 2019 12:01 +0100
EMA’s human medicines committee (CHMP) has recommended the authorisation of Palynziq (pegvaliase), a new medicine for patients aged 16 and older with...
First treatment for rare disease characterised by high levels of triglycerides in blood, CHMP, 01/03/2019
Fri, 01 Mar 2019 12:00 +0100
The European Medicines Agency has recommended granting a conditional marketing authorisation (CMA) for Waylivra (volanesorsen), the first medicine for...
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 February 2019, CHMP, 01/03/2019
Fri, 01 Mar 2019 12:00 +0100
EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including two orphan medicines1, at its February 2019 meeting. For three...
Change of time zone due to EMA's relocation in March 2019, , 01/03/2019
Fri, 01 Mar 2019 11:35 +0100
EMA leaves its London premises on 1 March 2019 and relocate to Amsterdam, the Netherlands.During EMA's period of reduced virtual presence from 4 March to...
New add-on treatment for patients with severe asthma, CHMP, 01/03/2019
Fri, 01 Mar 2019 10:57 +0100
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication to Dupixent (dupilumab) as an add-on maintenance treatment for...
First guidance on new rules for certain medical devices , , 28/02/2019
Thu, 28 Feb 2019 12:15 +0100
EMA has published today the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on...
Procedural update on submission of Type I variations to EMA in March, April and May 2019, , 26/02/2019
Tue, 26 Feb 2019 15:45 +0100
EMA is encouraging marketing authorisation holders (MAHs) intending to submit Brexit-related Type IA and Type IB variations in March 2019 to file these...

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