Results (3617)
Due to planned system maintenance, several EMA applications will be fully or partially inaccessible from 11 to 17 April.
NewsCorporate
The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2024.
NewsCorporate
The European Medicines Agency's (EMA) office is closed from 18:30 on Wednesday 27 March 2024 to 07:30 on Tuesday 2 April 2024. Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.
NewsCorporate
EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024.
NewsHumanMedicinesVaccines
Outcomes of the EMA Management Board meeting. The Management Board is an integral governance body of the Agency.
NewsHumanCorporateClinical trialsFees
EMA has recommended granting a marketing authorisation in the European Union (EU) for Emblaveo (aztreonam-avibactam), indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of bacteria (aerobic Gram-negative) where treatment options are limited.
NewsHumanMedicines
EMA has recommended granting a marketing authorisation in the European Union (EU) for Fabhalta (iptacopan), an oral treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia.
NewsHumanMedicines
EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting.
NewsHumanMedicinesReferrals
The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU).
NewsHumanClinical trials
Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting.
NewsVeterinaryMedicines