News and press releases
Update of EU recommendations for 2019–2020 seasonal flu vaccine composition, , 20/05/2019
Mon, 20 May 2019 12:31 +0200
EMA has issued an  update of the EU recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the...
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2019, PRAC, 17/05/2019
Fri, 17 May 2019 12:00 +0200
Restrictions in use of Xeljanz while PRAC reviews risk of blood clots in lungsEMA’s safety committee (PRAC) has started a new review of Xeljanz (...
Restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs, PRAC, 17/05/2019
Fri, 17 May 2019 12:00 +0200
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...
Withdrawal of marketing authorisations for fenspiride medicines, PRAC, 17/05/2019
Fri, 17 May 2019 12:00 +0200
EMA’s safety committee (PRAC) has recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be...
European Medicines Agency closed 9 May 2019, , 07/05/2019
Tue, 07 May 2019 11:27 +0200
EMA is closed from 18:30 on Wednesday 8 May until 07:30 on Friday 10 May 2019. Outside of working hours and on public holidays, it is possible to call...
Working together for safe medicines in the EU, , 06/05/2019
Mon, 06 May 2019 12:10 +0200
EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines available in Europe safe and effective.As...
EMA annual report 2018 published, , 03/05/2019
Fri, 03 May 2019 16:15 +0200
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...
Two additional countries to benefit from EU-US mutual recognition agreement for inspections, , 30/04/2019
Tue, 30 Apr 2019 14:00 +0200
In April 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good...
European Medicines Agency closed 1 May 2019, , 29/04/2019
Mon, 29 Apr 2019 10:01 +0200
EMA is closed from 18:30 on Tuesday 30 April until 07:30 on Thursday 2 May 2019. Outside of working hours and on public holidays, it is possible to call...
New long-lasting implant to treat opioid dependence, , 26/04/2019
Fri, 26 Apr 2019 15:00 +0200
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Sixmo (buprenorphine) as a...
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2019, CHMP, 26/04/2019
Fri, 26 Apr 2019 15:00 +0200
EMA’s human medicines committee (CHMP) recommended thirteen medicines for approval at its April 2019 meeting.The Committee recommended granting a...
EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo, , 26/04/2019
Fri, 26 Apr 2019 10:35 +0200
EMA has completed its assessment of the results of the ANNOUNCE study1 and concluded that Lartruvo (olaratumab) with doxorubicin does not prolong the...
EMA regrets to learn of the passing of Dr Eric Abadie, former CHMP Chair, , 25/04/2019
Thu, 25 Apr 2019 16:10 +0200
It is with great sadness that EMA has learned of the recent death of Dr Eric Abadie, former Chair of EMA's Committee for Medicinal Products for Human Use...
European Immunization Week 2019: statement by Executive Director Guido Rasi, , 24/04/2019
Wed, 24 Apr 2019 17:40 +0200
Vaccine-preventable diseases are making a comeback in Europe. Let’s take the example of measles, a potentially deadly disease. From July 2017 to June...
Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 15-16 April 2019, CVMP, 23/04/2019
Tue, 23 Apr 2019 11:00 +0200
CVMP recommends amendments to the product information for CytopointCVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a...

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