Here is our regular summary of content of relevance to neurology from the June issue of the European Medicines Agency’s (EMA) newsletter.
Key Updates:
EMA’s 30th anniversary celebrations to highlight patient engagement: Highlights the upcoming EMA 30th‑anniversary scientific conference on 25 June, marking three decades of progress in medicines and regulatory science.
Click here for more details: EUROPEAN MEDICINES AGENCY – EMA’s 30th anniversary celebrations to highlight patient engagement
Changes to the use of the antibiotic azithromycin: The CHMP has recommended restricting the use of azithromycin in the EU to help ensure appropriate use and curb antimicrobial resistance. It should no longer be used for certain conditions.
Click here for more details: Changes to the use of antibiotic azithromycin | European Medicines Agency (EMA)
Recommendation to update COVID-19 vaccines to target new LP.8.1 variant: EMA’s Emergency Task Force recommends updating COVID-19 vaccines for 2025/2026, as variant LP.8.1 is now dominant globally.
Click here for more details: ETF recommends updating COVID-19 vaccines to target new LP.8.1 variant | European Medicines Agency (EMA)
EMA starts review of ipidacrine-containing medicines: The EMA has begun reviewing ipidacrine-containing medicines, which are approved in several EU countries for treating nervous system disorders in adults.
Click here for more details: EMA starts review of ipidacrine-containing medicines | European Medicines Agency (EMA)
Consultation on a new guideline on inclusion of pregnant and breastfeeding individuals in clinical trials: The goal is to help generate solid clinical evidence in these groups for better-informed medicine use. Public comments on the draft guideline are open until 15 September 2025.
Click here for more details: New guideline on inclusion of pregnant and breastfeeding individuals in clinical trials | European Medicines Agency (EMA)
Consultation on the potential addition of a “key information section” to the template for medicines package leaflets.
Click here for more details: Product-information (QRD) templates – Human | European Medicines Agency (EMA)
Survey on EMA’s plain-language medicine summaries (medicine overviews) – until 6 July:
To help patients, carers, and healthcare professionals access key information on EU-authorised medicines, EMA publishes plain-language medicine overviews. These summaries explain how medicines work, their benefits and risks, and why they’re approved. EMA is running a short survey (5–10 minutes, available in all EU languages until 6 July) to assess their usefulness. Survey accessible here: EUSurvey – Survey
Medicines:
Ezmekly (mirdametinib) was granteda conditional marketing authorisation by EMA. Ezmekly (mirdametinb) is a non-competitive mitogen-activated protein kinase 1 and 2 (MEK 1/2) inhibitor, intended for the treatment of plexiform neurofibromas in adults and children from 2 years of age with neurofibromatosis type 1.
Click here for more details: Ezmekly | European Medicines Agency (EMA)
Riulvy (tegomil fumarate) was approved by EMA. It is an immunosuppressant that acts via its main active metabolite monomethyl fumarate, that is intended for the treatment of adults and children from 13 years of age with relapsing remitting multiple sclerosis.
Click here for more details: Riulvy | European Medicines Agency (EMA)
