Here is our regular summary of content of relevance to neurology from the Human Medicines Highlights – December 2025.
Key EMA News Updates:
- Political agreement on new EU pharmaceutical legislation
The EMA welcomed a political agreement on major reform of EU pharmaceutical legislation, aimed at modernising how medicines are developed, authorised and made available, while improving access, supply security and innovation. Click here for more details: EMA welcomes political agreement on new EU pharmaceutical legislation | European Medicines Agency (EMA) - Enhanced multi-lingual ACT EU Trial Map now available
The ACT EU clinical trials map has been improved with enhanced search capabilities in national languages, making it easier for patients and healthcare professionals to access clinical trial information in their preferred language. Click here for more details: Search for clinical trials – EMA - Podcast: Inside EMA – Episode 2
A new episode of the EMA’s Inside EMA podcast was highlighted, focusing on preparedness for the next pandemic. Click here for more details: Podcast: Inside EMA | European Medicines Agency (EMA) - New data on antimicrobial sales and use in animals
The EMA published its second annual surveillance report showing a slight increase in antimicrobial sales for animals and launched a new dashboard tool to publicly share veterinary antimicrobial sales data. Click here for more details: New data on antimicrobials sales and use in animals in the EU | European Medicines Agency (EMA)
Medicines
- Uplizna (inebilizumab) — The CHMP adopted a positive opinion for a new indication as an add-on to standard therapy for generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. Uplizna – opinion on variation to marketing authorisation | European Medicines Agency (EMA)
- Blarcamesine Anavex — The European Medicines Agency has recommended the refusal of the marketing authorisation for blarcamesine, intended for the treatment of Alzheimer’s disease, following a negative CHMP opinion. Blarcamesine Anavex | European Medicines Agency (EMA)
- Hetlioz (tasimelteon) — The CHMP issued a negative opinion on the extension of indication for the treatment of night-time sleep disturbance in children aged 3 to 15 years with Smith–Magenis syndrome. Hetlioz – opinion on variation to marketing authorisation | European Medicines Agency (EMA)
- Melatomed (and associated names) — On 11 December 2025, the EMA completed a review following a disagreement among EU Member States and concluded that the benefits outweigh the risks. Marketing authorisation can be granted in Germany, Austria, Denmark and Sweden. Melatomed and associated names – referral | European Medicines Agency (EMA)
- ADHD medicines shortages — There are ongoing shortages in some EEA countries of medicines used to treat attention-deficit/hyperactivity disorder (ADHD), including atomoxetine, methylphenidate and lisdexamfetamine. ADHD medicines – supply shortage | European Medicines Agency (EMA)
