Veterinary medicinal products containing albendazole as a single active substance presented as oral suspension in sheep - referral

Current status

European Commission final decision

Overview

On 16 April 2026, the EMA’s veterinary medicines committee, CVMP, completed a review concluding that the benefits of oral suspension veterinary medicines containing albendazole for sheep continue to outweigh their risks, provided some changes are made to their product information. Particularly, changes to the dosage regimen (dose rate and duration of treatment) for concerned veterinary medicines indicated for the treatment of gastrointestinal nematodes in sheep. The Committee also recommended to add appropriate warnings as a complementary risk management measure to further mitigate the emergence and spread of resistant parasite populations.

Oral solution veterinary medicines containing albendazole are marketed in many European Union Member States and have been widely used for decades in cattle, sheep, goats, pigs, rabbits, birds, dogs and cats. In ruminants, and in particular in sheep, they are used for the treatment of gastrointestinal nematodes, lungworms, tapeworms and adult liver flukes. However, emerging resistance has been reported throughout Europe for gastrointestinal nematodes in sheep.

The review of the CVMP was limited to the use in sheep for the treatment of gastrointestinal nematodes, specifically veterinary medicines authorised at doses or lower dose limits of 3.75-5 mg albendazole per kg bodyweight. The recommendations addressed concerns that this dosage regimen might not be appropriate to ensure effective use of these veterinary medicines, potentially contributing to the development of antiparasitic resistance. 

The recommendations follow a review by the CVMP of all available data for oral solution veterinary medicines containing albendazole, including scientific literature and studies (dose determination and dose confirmation, residue depletion, target animal safety and environmental safety studies). 

To ensure an effective use whilst minimising the risk of developing antiparasitic resistance to albendazole, the Committee concluded that the dose rate for the concerned veterinary medicines should be increased to 7.5 mg of albendazole per kg bodyweight administered as a single treatment for the treatment of gastrointestinal nematodes in sheep. This adjustment optimises efficacy without compromising safety, and it aligns with best parasitological practices for delaying the development of antiparasitic resistance. 

The Committee also concluded that this change does not raise new safety concerns for treated animals, users, consumers or the environment. This conclusion is further supported by the fact that a dose of 7.5 mg of albendazole per kg bodyweight is already authorised in all concerned veterinary medicines for another indication in sheep.

The CVMP considered it beneficial to include warnings in the product information to state additional strategies, including the prevention of underdosing, maintenance of refugia, targeted selective treatment, and routine parasitological monitoring. These measures are essential to slow the emergence and spread of resistant parasite populations.

The CVMP recommendations were sent to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 10 July 2026.

Information for veterinarians

• EMA recommended changes to the product information of oral solution veterinary medicines containing albendazole, to ensure that advice regarding their administration (dose rate and duration of treatment) is consistent across the EU while guaranteeing their correct use. 
• Since the recommended dose for the treatment of gastrointestinal nematodes in sheep is already authorised for a different indication in all the concerned veterinary medicines, no additional concerns are expected for target animals, users, consumers or the environment.
• Appropriate warnings in the product information are recommended as a complementary risk management measure to further mitigate the emergence and spread of resistant parasite populations.

More about the medicine

Albendazole is a well‑established, broad-spectrum antiparasitic medicine. Oral solution veterinary medicines containing albendazole within the scope of this referral have been used for decades in sheep to effectively treat a wide range of intestinal parasitic infections, including gastrointestinal infections with roundworms, lungworms, tapeworms and treatment of adult liver flukes.

More about the procedure

The review of oral solution veterinary medicines containing albendazole was initiated on 11 June 2025 at the request of Germany under Article 82 of Regulation (EU) 2019/6.

The review was carried out by the Committee for Veterinary Medicinal Products (CVMP), the Committee responsible for the evaluation of veterinary medicines, which made a set of recommendations. The CVMP recommendations were sent to the European Commission, which issued an EU-wide legally binding decision on 10 July 2026.

Albendazole - Article 82 referral - New recommendations for oral suspension veterinary medicines containing albendazole for sheep

Reference Number: EMA/163223/2026

Key facts

About this medicine

• Approved name:
  Veterinary medicinal products containing albendazole as a single active substance presented as oral suspension in sheep
• International non-proprietary name (INN) or common name:
  albendazole

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMA/REF/0000271819
• Type:
  Article 82 referrals

  This type of referral is triggered when the interests of the Union are involved, following concerns relating to the quality, safety or efficacy of veterinary medicines.

• Authorisation model:
  Nationally authorised product(s)

Key dates and outcomes

• Procedure start date:
  11/06/2025
• EC decision date:
  10/07/2026

All documents

Procedure started

Albendazole - Article 82 referral - CVMP list of questions to be addressed by the stakeholders

Reference Number: EMA/CVMP/180973/2025

Albendazole - Article 82 referral - CVMP list of questions to be addressed by the marketing authorisation holders

Reference Number: EMA/CVMP/180970/2025

Albendazole - Article 82 referral - Notification

Albendazole - Article 82 referral - Stakeholder submission form

Albendazole - Article 82 referral - Start of review concerning veterinary medicines containing albendazole

Reference Number: EMA/201370/2025

European Commission final decision

Albendazole - Article 82 referral - Annex I, II, III

Albendazole - Article 82 referral - Timetable for the procedure under Article 82 of Regulation (EU) 2019/6

Reference Number: EMA/CVMP/173707/2025 – Rev. 1

Albendazole - Article 82 referral - Annex I

Draft Reference Number: EMA/181435/2025

Albendazole - Article 82 referral - New recommendations for oral suspension veterinary medicines containing albendazole for sheep

Reference Number: EMA/163223/2026

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of CVMP
• Divergent positions – divergent positions of the CVMP members (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)