Results (3623)
On 24 January 2024, the CMDh endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines. These measures are to address a potential increased risk of neurodevelopmental disorders in children born to men treated with valproate during the 3 months before conception...
On 25 January 2024, EMA’s human medicines committee (CHMP) endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) for medicines containing pseudoephedrine.
EMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.
EMA has published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.
The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector.
In 2023, EMA recommended 77 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union (EU) before.
Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures
EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines.
The midterm report of the European Medicines Agencies Network Strategy finds the pandemic strengthened the network and supported transformative change in the European system across key strategic areas.