Here is our regular summary of content of relevance to neurology from the September 2025 issue of the European Medicines Agency’s (EMA) newsletter.
Key EMA News Updates:
- Use of paracetamol during pregnancy unchanged in the EU: in the EU, paracetamol (also known as acetaminophen) can be used for reducing pain or fever during pregnancy if clinically needed. There is currently no new evidence that would require changes to the current EU recommendations for use. Click here for more details: Use of paracetamol during pregnancy unchanged in the EU | European Medicines Agency (EMA)
- Warning about sharp rise in illegal medicines sold in the EU: illegal medicines marketed as GLP-1 receptor agonists for weight loss and diabetes pose serious risk to health. The EMA and the Heads of Medicines Agencies (HMA) are warning the public about the growing threat of illegal medicines being advertised and sold online across the EU. Suspicious websites, advertisements or products should be reported to your national competent authority. Click here for more details: Warning about sharp rise in illegal medicines sold in the EU | European Medicines Agency (EMA)
- EMA and WHO mark ten years of collaboration to advance global access to medicines: theEMA and the World Health Organization are celebrating a decade of formal collaboration and shared commitment to addressing global health challenges. Since the signing of a confidentiality arrangement in September 2015, their partnership has focused on cooperation on scientific evaluation, capacity building, enhancing regulatory efficiency to contribute to public health worldwide. Click here for more details: EMA and WHO mark ten years of collaboration to advance global access to medicines | European Medicines Agency (EMA) Agency (EMA)
- New targets for clinical trials in Europe: the European Commission, the Heads of Medicines Agencies and the EMA have jointly developed two new targets for clinical trials, to monitor progress against the ambition to make the EU a more attractive destination for clinical research and improve timely access to innovative medicines for patients. Click here for more details: New targets for clinical trials in Europe | European Medicines Agency (EMA)
- PRAC starts safety review of levamisole, a medicine used to treat parasitic worm infections: the EMA’s safety committee (PRAC) has started a review of medicines containing levamisole, authorised in four EU countries to treat infections caused by parasitic worms in adults and children. The review follows concerns about a risk of leukoencephalopathy with levamisole, a potentially serious condition that damages the white matter of the brain. Click here for more details: PRAC starts safety review of levamisole, a medicine used to treat parasitic worm infections | European Medicines Agency (EMA)
Medicines:
- Imaavy (nipocalimab): new medicine recommended for approval. On 18 September 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Imaavy, intended for the treatment of generalised myasthenia gravis: Imaavy | European Medicines Agency (EMA)
- Koselugo (selumetinib): change of indication. On 18 September 2025 the CHMP adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Koselugo. The marketing authorisation holder for this medicinal product is AstraZeneca AB: Koselugo – opinion on variation to marketing authorisation | European Medicines Agency (EMA) Kisunla | European Medicines Agency (EMA)
- Tuzodi (midazolam): withdrawal of application. Regulatory Pharma Net s.r.l. withdrew its application for a marketing authorisation of Tuzodi for the treatment of convulsive seizures in adults and children from two years of age: Tuzodi | European Medicines Agency (EMA)
- Clozapine: direct healthcare professional communication (DHPC). This DHPC contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s). It also includes a communication plan with details of intended recipients and the dissemination date: Clozapine – direct healthcare professional communication (DHPC) | European Medicines Agency (EMA)
- Evrysdi (risdiplam): DHPC. This DHPC contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s). It also includes a communication plan with details of intended recipients and the dissemination date: Evrysdi – direct healthcare professional communication (DHPC) | European Medicines Agency (EMA)
- Uplizna (inebilizumab): new indication. On 18 September 2025, the CHMP adopted a positive opinion recommending a change to the terms of the marketing authorisation for Uplizna in adult patients with immunoglobulin G4-related disease (IgG4-RD). Uplizna is already approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive: Uplizna – variation | European Medicines Agency (EMA)
