Netherlands CBG News

Imdylltra Positive CHMP Opinion for Extensive-Stage Small Cell Lung Cancer

The European Medicines Agency's CHMP, with Dutch participation through CBG-MEB, issued a positive opinion recommending Imdylltra (tarlatamab) for marketing authorization as an immunotherapy for adults with extensive-stage small cell lung cancer (ES-SCLC). The opinion is based on a study of over 500 patients showing longer survival compared to standard treatment. The most serious side effects include cytokine-release syndrome and neurological inflammation. The opinion has been forwarded to the European Commission for final decision on marketing authorization.

CBG-MEB Issues Registration Call for Lithium Carbonate Tablets to Address Medicine Shortages

CBG-MEB is publishing a call for registration of lithium carbonate 200mg, 300mg, and 400mg tablets as part of its new initiative to address urgent medicine shortages where prolonged unavailability is expected. Lithium carbonate is used to stabilise mood swings in patients with bipolar disorder, treating and preventing manic and depressive episodes. Marketing authorisation holders or companies interested in bringing these medicines to the Dutch market can contact CBG-MEB directly to explore registration pathways.

Netherlands Temporarily Authorizes Vaxxon Clone ND Vaccine Amid EU Shortage

The Bureau Diergeneesmiddelen (BD) has granted temporary authorization for Vaxxon Clone, an ND vaccine not approved on the EU market, for use in the Netherlands. The authorization addresses an acute shortage caused by reduced production of SPF eggs (needed for live vaccine production) due to bird flu cullings at suppliers, combined with increased demand from ND outbreaks in Poland since October 2025 and now in Germany. Commercial poultry keepers and turkey farmers in the Netherlands, where ND vaccination is mandatory, should verify their vaccination status and source supply through the temporary authorization mechanism.