BVL approves new veterinary medicinal products and amends 82 existing authorizations

The Federal Office of Consumer Protection and Food Safety (BVL) has granted three new authorizations for prescription veterinary medicinal products and determined the loss of marketability for two further preparations in a notification dated August 25, 2026. The decision was published on Wednesday, September 16, 2026, in the Federal Gazette (Bundesanzeiger) under the official reference BAnz AT 16.09.2026 B6. Additionally, the notification lists 82 amendments to existing authorizations and registrations.

The legal basis is Section 36 of the Veterinary Medicinal Products Act in the version of the announcement of September 27, 2021 (BGBl. I p. 4530). The BVL is the competent federal authority for the authorization and registration of veterinary medicinal products in Germany; the notification bears the reference number 300.30406.0.556694 and is dated August 25, 2026, in Berlin, signed “By order” of Prof. Heberer. The office explicitly points out that the announcement of the decisions does not contain information regarding the existence of immediate execution or legal force.

Three new authorizations for prescription preparations

Three prescription veterinary medicinal products have been newly authorized or registered:

• Lyncoo (Auth. No. V7019794.00.00), authorization dated October 3, 2025, applicant Endectovet EOOD
• MILBETAB 2.5 mg/25 mg chewable tablets for small dogs and puppies (Auth. No. V7016737.00.00), authorization dated October 15, 2025, applicant Chanelle Pharmaceuticals Manufacturing Ltd.
• MILBETAB 12.5 mg/125 mg chewable tablets for dogs (Auth. No. V7016738.00.00), authorization dated October 15, 2025, applicant Chanelle Pharmaceuticals Manufacturing Ltd.

Two preparations lose marketability

Marketability for two medicinal products ends on the following dates:

• Adequan (Auth. No. 2106783), marketable until June 11, 2025, applicant Daiichi Sankyo Altkirch S.a.r.l.
• agramelk Iod (Auth. No. 2400276), marketable until June 24, 2025, applicant Agraria Pharma GmbH

82 amendments to existing authorizations

The largest block consists of 82 amendments to authorizations and registrations. Preparations for livestock and pets are affected, including horses, cattle, pigs, sheep, dogs, and cats. Multiple entries include, among others:

• Boehringer Ingelheim Vetmedica GmbH with nine entries, including Benestermycin, Ingel-Mamyzin, IVOMEC Pour-On, Ivomec.P, and five Frontline preparations
• SaluVet GmbH with nine entries from the PlantaVet range, including Disci comp., Hepar comp., Lachesis/Argentum comp., Nux vomica comp., and Pulmo/Stibium comp.
• Industrial Veterinaria S.A. with seven entries, including Boflox, Espacox, three Metrovis tablets, and two Tullavis solutions for injection
• Zoetis Deutschland GmbH with six entries, including three Banminth preparations, Excenel, Orbenin LA, and Synulox RTU
• Intervet Deutschland GmbH with five entries, including Exspot, Karsivan, and Panacur SR Bolus
• Eurovet Animal Health BV with five entries, including Anesketin 100 mg/ml solution for injection and four variants of Forthyron flavour
• CP-Pharma Handelsgesellschaft mbH with four entries, including Butorgesic 10 mg/ml and three Thiamatab strengths
• Virbac with four entries, including Cloxacillin-TS-1000, OXFENIL, Rilexine DC, and Zoletil 100

Individual changes also affect preparations from Elanco GmbH (Bolfo, Sebacil Pour-on), Laboratorios Hipra S.A. (EFICUR, SELECTAN), Norbrook Laboratories (Ireland) Limited (Betafuse, Norfenicol), Phibro Animal Health (Poland) Sp. z o.o. (Duphamycin Meta, Lincospectin), Vetoquinol GmbH (three DOLPAC tablets), Alfasan Nederland B.V. (two Euthanimal solutions for injection), CEVA TIERGESUNDHEIT GmbH (Wellicox, three Xeden tablets), Dechra Regulatory B.V. (INFUSOLEC), Domes Pharma (Stromease), Laboratorios Syva S.A. (Procactive), Laboratorios Karizoo S.A. (Soluvit AD3E form), Bela-Pharm GmbH & Co.KG (Ketabel 100 mg/ml), Serumwerk Bernburg AG (Ketamine), Vetviva Richter GmbH (Lidor 20 mg/ml), vitOrgan Arzneimittel GmbH (NeyDIL 7), Veyx-Pharma GmbH (Cloxin TS-Retard-Injektor), Ecuphar Veterinaria S.L.U. (Danilon Equidos), Dopharma Research B.V. (Butagran Equi), Biovet AD (Tylmasin), and Dr. Assmann Veterinärspezialitäten GmbH (B-Vetsan).

For veterinary practices, manufacturers, and owners of livestock and pets, the announcement means an immediate change in the permitted range of medicinal products: while the three new authorizations open up additional treatment options, Adequan and agramelk Iod may no longer be placed on the market as of June 11 and June 24, 2025, respectively. The complete list containing all authorization numbers and applicants can be found in the official text.

Source: Bundesanzeiger, BAnz AT 16.09.2026 B6 dated September 16, 2026, Announcements, pp. 1–3 (official reference: BAnz AT 16.09.2026 B6).