RegulatoryOfficial

AEMPS committee backs batch of new generics at November 2026 meeting

🇪🇸 AEMPS · Tue 10 Nov 2026

Spain's human medicines committee gave favourable opinions to new generic products, including anticoagulants, kinase inhibitors and diabetes combinations, with the next meeting set for 1 December 2026.

The Committee for Medicinal Products for Human Use (CMH) of the Spanish Medicines Agency (AEMPS) met by teleconference on 3 November 2026. AEMPS published the outcome on 10 November under reference MUH (CMH) 10/2026. The committee gave a favourable opinion on a series of new medicines.

The list in the note is made up of generics with a Spanish official name (DOE), all marked EFG. Products named include apixaban, edoxaban, lenvatinib, palbociclib, ruxolitinib, tofacitinib, nintedanib, cladribine and teriflunomide. Other entries cover linagliptin alone and with metformin, octreotide prolonged-release suspension, midazolam, azithromycin infusion powder, carbetocin, pantoprazole, safinamide, tadalafil and an ibuprofen/caffeine granule.

Several active substances have more than one company listed. Edoxaban is listed for Zentiva in three strengths. Ruxolitinib appears for both Olpha and Pharmconsul, each in four strengths. Nintedanib appears for Reig Jofre and Sun, and tofacitinib for Accord and Glenmark. The text available for this report breaks off mid-entry within the tofacitinib listings, so it may not show the full list.

AEMPS states that the list is neither definitive nor binding. The next CMH meeting is scheduled for 1 December 2026.

What it means for your team

  • Market-access and commercial teams can use the list as an early indicator of generic competition in Spain for the named substances, remembering that AEMPS calls it non-definitive and non-binding.
  • Regulatory teams should check the full published note for the complete list, as the text reviewed here appears truncated.
  • This is an administrative meeting outcome, not a safety action, so it needs no pharmacovigilance response.
  • The next CMH meeting on 1 December 2026 is the next scheduled point for further opinions.

Official source: AEMPS ↗

Article written by VigiEye from the official source (AEMPS). AI-assisted; check the source before acting.

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