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

Current status

Procedure started

Overview

EMA has started a review of veterinary medicines containing albendazole as a single active substance presented as oral suspension indicated against gastrointestinal nematodes in sheep.

These veterinary medicines have been used widely throughout the EU for decades. It has been noticed that the authorised doses of 3.75-5 mg of albendazole/kg bodyweight of the concerned veterinary medicines might no longer be appropriate to ensure the effective use against gastrointestinal nematodes. This could also contribute to a risk of development of antiparasitic resistance.

Having considered this issue, the national veterinary medicines regulatory authority of Germany requested EMA’s veterinary medicines committee (CVMP) to assess its impact on the benefits and risks of veterinary medicinal products containing albendazole as a single active substance presented as oral suspension indicated against gastrointestinal nematodes in sheep.

EMA will now review the available data to determine if any action is necessary to protect animal or public health or the environment.

More about the medicines

The review covers veterinary medicines containing albendazole as a single active substance presented as oral suspension indicated against gastrointestinal nematodes in sheep. 

More about the procedure

The review has been initiated at the request of the veterinary medicines regulatory agency of Germany under Article 82 of Regulation (EU) 2019/6. The review is being carried out by the Committee for Veterinary Medicinal Products (CVMP), responsible for questions concerning medicines for veterinary use, which will adopt the Agency’s opinion. The CVMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

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

Reference Number: EMA/201370/2025

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:
  Procedure started
• Reference number:
  EMA/REF/0000271819
• Type:
  Article 82

  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

All documents

Procedure started

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

Reference Number: EMA/CVMP/173707/2025

Albendazole - Article 82 referral - Annex I

DraftReference Number: EMA/181435/2025

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

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)