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ema.europa.eu

Friday, Jul 26

13

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2024

www.ema.europa.eu

EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2024 meeting.The CHMP recommended granting a marketing authorisation for Anzupgo (…, Positive recommendations on new medicines , Anzupgo International…

EMA advises about risks of using weight loss medicine Mysimba with opioids

www.ema.europa.eu

Following a routine review of the safety of the weight loss medicine Mysimba (naltrexone/bupropion), EMA recommends strengthening existing advice to minimise the risks from…

Friday, Jul 19

14

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 July 2024

www.ema.europa.eu

CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation application for Cepeloron (…

Friday, Jul 12

13

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024

www.ema.europa.eu

PRAC elects new chairThe July 2024 meeting of EMA’s safety committee (PRAC) was the last plenary meeting chaired by Sabine Straus, who retires as Chair after serving for…, Agenda Agenda of the PRAC meeting 8-11 July 2024DraftReference…

Thursday, Jul 11

16

EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna

www.ema.europa.eu

Update as of 11 July 2024:The company for Translarna has requested a re-examination of EMA’s June 2024 opinion. Upon receipt of the grounds of this request, the Agency will re-…

13

EMA’s safety committee elects new chair

www.ema.europa.eu

At its July 2024 meeting, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) elected Ulla Wändel Liminga as its new Chair for a three-year mandate starting in…, At its July 2024 meeting, EMA’s Pharmacovigilance Risk Assessment…

Thursday, Jul 4

Recent additions to EMA’s management team

www.ema.europa.eu

Georgia Gavriilidou joined EMA on 1 July 2024 as the new Head of the Legal Department, following the retirement of Stefano Marino. She brings over 17 years of in-depth legal and…

Friday, Jun 28

14

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024

www.ema.europa.eu

EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its June 2024 meeting.The committee recommended granting a marketing authorisation …, Positive recommendations on new medicines , Balversa Common name…

Positive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertension

www.ema.europa.eu

EMA has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (…

Wednesday, Jun 26

16

EU actions to tackle shortages of GLP-1 receptor agonists

www.ema.europa.eu

EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to tackle…, “We need to step up actions now - industry, regulators,…

Friday, Jun 21

15

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-19 June 2024

www.ema.europa.eu

The Committee adopted by consensus a positive opinion for a marketing authorisation for DIVENCE IBR Marker Live from Laboratorios Hipra, S.A., a new vaccine intended for the…

Tuesday, Jun 18

12

Faster access to clinical trial information in Europe

www.ema.europa.eu

The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European…

Friday, Jun 14

17

Review of painkiller metamizole started

www.ema.europa.eu

EMA has started a review of medicines containing the painkiller metamizole following concerns that the measures in place to minimise the known risk of agranulocytosis may not be…

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024

www.ema.europa.eu

Review of painkiller metamizole startedReview will look into risk of agranulocytosis, a sudden drop in white blood cells that can lead to serious infections, and measures to…, Agenda Agenda of the PRAC meeting 13-16 May 2024DraftReference…

16

EMA Management Board: highlights of June 2024 meeting

www.ema.europa.eu

Positive assessment of EMA’s activities in 2023The Management Board assessed and adopted the Executive Director’s annual activity report for 2023. The report describes the…

Monday, Jun 10

13

Two new advice pilots to improve clinical trials in Europe

www.ema.europa.eu

The Accelerating Clinical Trials in the EU (ACT EU) initiative is today launching two advice pilots aimed at improving the quality of applications for clinical trials, the…

Monday, Jun 3

17

EU recommendations for 2024/2025 seasonal flu vaccine composition

www.ema.europa.eu

The news announcement was updated on 3 June 2024 to include a recommendation for seasonal live attenuated influenza vaccine strains and updated information for a strain for cell-…, EMA has issued recommendations for the influenza virus…

Friday, May 31

14

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024

www.ema.europa.eu

EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its May 2024 meeting.The CHMP recommended granting a marketing authorisation under exceptional…, Positive recommendations on new medicines , Adzynma Common…

13

First vaccine to protect adults from Chikungunya

www.ema.europa.eu

EMA has recommended granting a marketing authorisation in the European Union (EU) for Ixchiq, the first vaccine in the EU to protect adults 18 years and older against Chikungunya…

12

New gene therapy treatment for haemophilia B

www.ema.europa.eu

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Durveqtix (fidanacogene elaparvovec) to treat severe and moderately severe…

Thursday, May 30

Annual report highlights progress in science, medicines and health in 2023

www.ema.europa.eu

EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the European Union (EU). With a fresh layout and new interactive…

Friday, May 24

13

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 May 2024

www.ema.europa.eu

CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation for Nobilis Multriva RT+IBm+ND+EDS, from…

Tuesday, May 21

15

EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna

www.ema.europa.eu

Update as of 21 May 2024The European Commission has asked the CHMP to review its January opinion on the renewal of the marketing authorisation for Translarna. The CHMP will now…

Medical devices: new guidance for industry and notified bodies

www.ema.europa.eu

A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. This question-and-answer…

10

Have your say and help shape EMA’s future communications

www.ema.europa.eu

EMA has launched its biennial communication perception survey. The purpose of the survey is to collect feedback on EMA’s external communications from patients, consumers,…

Monday, May 20

15

European medicines network designated as WHO listed authority

www.ema.europa.eu

This means that the network, composed of the European Commission, EMA and the 30 national authorities of the European Economic Area Member States, are recognised as meeting…

Friday, May 17

17

Hydroxyprogesterone caproate medicines to be suspended from the EU market

www.ema.europa.eu

EMA’s safety committee, PRAC, has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European…

13

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024

www.ema.europa.eu

Hydroxyprogesterone caproate medicines to be suspended from the EU marketEMA’s safety committee (PRAC) has recommended the suspension of the marketing authorisations for medicines…, Agenda Agenda of the PRAC meeting 13-16 May…

Thursday, May 16

15

EMA closed on Whit Monday, 20 May

www.ema.europa.eu

Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is an emergency number and should…

Tuesday, May 7

EMA closed 9-10 May

www.ema.europa.eu

Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is an emergency number and should…