PharmacovigilanceOfficial

Spain's CODEM-VET backs four veterinary products at October 2026 meeting

🇪🇸 AEMPS · Fri 06 Nov 2026

AEMPS says its veterinary committee gave favourable opinions on four marketing authorisation applications on 14 October; formal authorisation decisions are still to be issued by the agency's management.

The Spanish Agency for Medicines and Health Products (AEMPS) has published the note on the October 2026 meeting of its Veterinary Medicines Committee (CODEM-VET), referenced MVET (CODEM VET) 09/2026. The committee met on 14 October 2026 and assessed a series of marketing authorisation applications, as well as requests to change the authorisation conditions of products already registered.

The note lists only those applications that completed their procedure and received a favourable opinion. AEMPS states that the corresponding authorisation resolutions have yet to be issued by the agency's management, so the products are not yet formally authorised on the basis of this note.

One product came through the subsequent recognition procedure: Intertrim vet, a generic (Article 18) from Interchemie Werken de Adelaar Eesti AS under procedure EE/V/0110/001/MR. It contains sulfadoxine and trimethoprim and targets cattle, goats, horses, pigs, dogs and sheep.

Three applications went through decentralised procedures. Rhemox premix 100 mg/g, a medicated premix for pigs from Industrial Veterinaria S.A. (ES/V/0129/001/E/001), is a full application (Article 8) containing amoxicillin trihydrate. Release 500 mg/ml solution for injection, from Wirtschaftsgenossenschaft Deutscher Tieraerzte EG (NL/V/0230/001/DC), is a hybrid application (Article 19) for sodium pentobarbital, with a wide list of target species including farm animals, pets, small mammals, birds and reptiles. Xylazine forte healthcare 20 mg/ml, from Forte Healthcare Licencing Limited (CZ/V/0211/001/DC), is a generic (Article 18) xylazine hydrochloride injection for cattle, horses, dogs and cats.

The next CODEM-VET meeting is scheduled for 11 November 2026.

What it means for your team

  • Market-access teams tracking Spain's veterinary sector should note four favourable opinions, but wait for AEMPS authorisation resolutions before treating the products as authorised.
  • The list covers one generic via subsequent recognition, one full application, one hybrid and one generic through decentralised procedures, with procedure numbers useful for tracking.
  • The note has limited relevance to human-medicine pharmacovigilance.
  • The next committee meeting on 11 November 2026 is the next point at which further opinions may emerge.

Official source: AEMPS ↗

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

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