PharmacovigilanceOfficial

Spain's veterinary committee backs seven decentralised applications, including pimobendan chews and deltamethrin collars

🇪🇸 AEMPS · Fri 13 Nov 2026

AEMPS's CODEM-VET issued favourable opinions on seven decentralised-procedure applications at its 11 November meeting; formal authorisation decisions remain pending.

The Spanish Agency for Medicines and Health Products (AEMPS) has published the note from the November 2026 meeting of its Veterinary Medicines Committee (CODEM-VET), held on 11 November. The committee assessed marketing authorisation applications and requests to change the terms of existing authorisations. The note lists only those that completed their procedure with a favourable opinion.

All seven products listed fall under decentralised procedures. Authorisation decisions from the AEMPS director's office are still to be issued. Two deltamethrin medicated collars from Quimica de Munguía, Kuivet 1 g for medium and large dogs and Kuivet 0.76 g for small dogs, are hybrid applications under Article 19, with Spain as reference member state.

Vetviva Richter GmbH has four Pimodil pimobendan chewable tablets for dogs, led by Ireland as reference member state. The 1.25 mg and 10 mg strengths are hybrid applications under Article 19, while the 2.5 mg and 5 mg strengths are generic applications under Article 18.

The remaining two products are Dorzidil 20 mg/ml eye drops for dogs, a bibliographic application under Article 22 from Trebifarma S.R.L. (dorzolamide hydrochloride; Czech procedure), and Tri-Solfen Sterile solution from Dechra Regulatory B.V. The latter is a full Article 8 application for piglets, combining lidocaine, bupivacaine, cetrimide and epinephrine (Dutch procedure). The next CODEM-VET meeting is scheduled for 9 December 2026.

What it means for your team

  • Favourable CODEM-VET opinions are not authorisations: Spanish resolutions from the AEMPS director are still pending for all seven products.
  • Teams tracking veterinary generics and hybrids should note the four Pimodil pimobendan strengths and the two Kuivet deltamethrin collars, all from single applicants.
  • Tri-Solfen, a full-dossier application for piglets, is the only new combination-active product on the list.
  • The next committee meeting on 9 December 2026 is the next point for further national opinions.

Official source: AEMPS ↗

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

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