On October 26, 2026, the European Medicines Agency published the Pharmacovigilance Risk Assessment Committee recommendations adopted at the meeting of 28 September to 1 October 2026, under reference EMA/PRAC/206892/2026. Requests for supplementary information are directly actionable by the holders named. Product-information amendments go to the CHMP for endorsement when the product is centrally authorised, and to the CMDh for information when it is nationally authorised.
Pierre Fabre Medicament, the EU marketing authorisation holder of Braftovi (encorafenib) and Mektovi (binimetinib), Ebewe Pharma and other EU marketing authorisation holders of cisplatin, Novo Nordisk A/S for liraglutide and semaglutide, Pfizer Europe MA EEIG for elranatamab (Elrexfio), and Amgen Europe B.V. for tarlatamab must submit the Braftovi and Mektovi product-information variation adding neutropenia as a common undesirable effect within two months of the October 26, 2026 publication, and file the requested supplementary information on cisplatin acute pancreatitis, semaglutide ischaemic colitis and tarlatamab tumour lysis syndrome by December 1, 2026, or product information that is not kept aligned with the published PRAC conclusions breaches Article 16(3) of Regulation (EC) No 726/2004 and Article 23(3) of Directive 2001/83/EC. CHMP oversees adherence for centrally authorised products. National competent authorities do so for nationally authorised products.
What product-information text does EMA/PRAC/206892/2026 require for encorafenib and binimetinib?
Pierre Fabre Medicament must submit a variation within two months of publication of EMA/PRAC/206892/2026 to add neutropenia as a common undesirable effect. The signal is EPITT 20255, rapporteur Carla Torre (Portugal), adoption date October 1, 2026, centralised procedure. PRAC agreed that conclusion from EudraVigilance, clinical studies and the literature.
For encorafenib, section 4.8 of the summary of product characteristics adds, in Table 5 under "Encorafenib 450 mg in combination with binimetinib", system organ class Blood and lymphatic system disorders, frequency Common: Neutropenia. The Braftovi leaflet, for side effects when Braftovi and binimetinib are taken together for melanoma or non-small cell lung cancer, adds a Common line (may affect up to 1 in 10 people): decrease in the number of white blood cells, cells that fight infection (neutrophils). Binimetinib section 4.8 adds the same system organ class, frequency Common: Neutropenia. The Mektovi leaflet, under other side effects when Mektovi and encorafenib are taken together, adds the same neutrophil line. Official-language translations of that wording are available to holders on the EMA website.
At publication, CHMP had agreed this update for the centrally authorised products at its plenary of October 12 to 15, 2026, and will assess the variations. The timeline applies to the innovator and to generics unless the recommendation says otherwise. National variations, including mutual recognition and decentralised procedures, are handled by the Member States.
Who must file supplementary information by December 1, 2026?
Three named holders must submit supplementary information by December 1, 2026. Ebewe Pharma must respond on cisplatin and acute pancreatitis (EPITT 20319, rapporteur Marie Louise Schougaard Christiansen, Denmark). Novo Nordisk A/S must respond on semaglutide and ischaemic colitis (EPITT 20309, rapporteur Karin Bolin, Sweden). Amgen Europe B.V. must respond on tarlatamab and tumour lysis syndrome (EPITT 20313, rapporteur Jan Neuhauser, Austria).
| Substance | Signal (EPITT) | Action stated | Holder named | Date |
|---|---|---|---|---|
| Cisplatin | Acute pancreatitis (20319) | Supplementary information | Ebewe Pharma | December 1, 2026 |
| Semaglutide | Ischaemic colitis (20309) | Supplementary information | Novo Nordisk A/S | December 1, 2026 |
| Tarlatamab | Tumour lysis syndrome (20313) | Supplementary information | Amgen Europe B.V. | December 1, 2026 |
| Encorafenib and binimetinib | Neutropenia (20255) | Product-information variation | Pierre Fabre Medicament | Within two months of the October 26, 2026 publication |
Which other signals in EMA/PRAC/206892/2026 carry a later or routine action?
Pfizer Europe MA EEIG must assess tumour lysis syndrome with elranatamab (EPITT 20314, rapporteur Barbara Kovacic Bytyqi, Croatia) in the next periodic safety update report, submission by October 22, 2026. Novo Nordisk A/S must assess alopecia with liraglutide, including the combination with insulin degludec (EPITT 20311, rapporteur Bianca Mulder, Netherlands), submission by March 31, 2027, and must reassess gastrointestinal volvulus with semaglutide, including the combination the text lists as inulin icodec/semaglutide (EPITT 20260, rapporteur Karin Bolin), submission by August 29, 2027.
AstraZeneca AB is assigned routine pharmacovigilance for lichen sclerosus with dapagliflozin and the combinations with metformin, saxagliptin and sitagliptin (EPITT 20259). Eli Lilly and Company (Ireland) Limited must monitor Behçet's syndrome with ixekizumab in the periodic safety update report (EPITT 20269, rapporteur Dirk Mentzer, Germany). Use the EPITT number in any communication on a signal.
What follows if the product information is left unchanged?
Article 16(3) of Regulation (EC) No 726/2004 and Article 23(3) of Directive 2001/83/EC require the holder to keep product information aligned with current scientific knowledge, including the assessment conclusions and the recommendations published on the EMA website. Braftovi or Mektovi texts that omit the agreed neutropenia wording after the variation window fall under that duty. For nationally authorised products, Member State competent authorities oversee adherence. The recommendation states no separate fine amount.
Continuous, per-jurisdiction monitoring on Obsidian surfaces a PRAC signal recommendation of this kind the moment the EMA publishes it.
Confirm whether an authorisation you hold is named in EMA/PRAC/206892/2026, or is a generic of encorafenib or binimetinib on the same timeline. Diary December 1, 2026 for the three supplementary responses, and the two-month variation counted from October 26, 2026 for Braftovi and Mektovi. Brief pharmacovigilance on the section 4.8 lines and on the periodic safety update report dates of October 22, 2026, March 31, 2027 and August 29, 2027.
