Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products - referral

Current status

European Commission final decision

Overview

On 5 November 2020, the European Medicines Agency (the Agency) completed a review of the withdrawal periods (milk, meat and offal) for cattle for Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products. The withdrawal period is the minimum time that has to elapse before an animal treated with a medicine can be slaughtered so that its meat or other animal derived products may be used for human consumption.

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of these medicines continue to outweigh the risks, but that the withdrawal periods for cattle should be changed to provide assurance for consumer safety.

What are Valbazen and its generic/hybrid products?

The veterinary medicines Valbazen and its generic/hybrid products are oral suspensions containing 100 mg or 200 mg albendazole per ml. Albendazole is a broad-spectrum multi-purpose antiparasitic used for the treatment of gastrointestinal infestations with roundworms, lungworms and tapeworms and adult flukes of Fasciola hepatica. Veterinary medicines containing albendazole are used in cattle most often as single oral use.

Why were Valbazen and its generic/hybrid products reviewed?

On 3 February 2020, the German veterinary medicines authority requested that the CVMP review all available data and recommend withdrawal periods for milk, meat and offal from cattle treated with Valbazen and its generic/hybrid products.

The German authority considered that the withdrawal periods for cattle in the European Union (EU) might not be adequate to ensure consumer safety, noting that they differed across the EU, ranging from 5 to 28 days for edible tissues and from 72 to 120 hours for milk.

The Committee was requested to issue an opinion on whether the marketing authorisations for the above-mentioned products should be maintained, varied, suspended or withdrawn across the European Union.

Which data has the CVMP reviewed?

The CVMP reviewed available data on residue depletion in cattle for the veterinary medicines Valbazen and its generic/hybrid products, which indicate how long a medicine takes to fall below maximum residue limits (MRLs) in the animal’s body. These contained data from companies, including studies and published literature.

What are the conclusions of the CVMP?

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the benefits of Valbazen and its generic/hybrid products continue to outweigh the risks. The CVMP recommended that for the protection of consumer safety, the withdrawal periods for milk, meat and offal from cattle treated with these veterinary medicines should be 84 hours for milk and 7 days for meat and offal.

The Committee recommended the variation to the terms of the marketing authorisation for these veterinary medicines.

The full changes made to the product information are detailed in Annex III of the CVMP opinion under 'All documents'.

The European Commission issued a decision on 18 January 2021.

Valbazen and generics Article 35-referral - Questions and answers on the review of withdrawal periods for Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products

Reference Number: EMA/42905/2021

Key facts

About this medicine

• Approved name:
  Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products
• International non-proprietary name (INN) or common name:
  albendazole

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA-V-A-140
• Type:
  Article 35 referrals (prior to January 2022)

  This type of referral is initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

• Authorisation model:
  Centrally and nationally authorised products (mixed)

Key dates and outcomes

• Opinion date:
  05/11/2020
• EC decision date:
  18/01/2021

All documents

European Commission final decision

Valbazen and generics Article-35 referral - Annex I-III

Valbazen and generics Article 35-referral - Questions and answers on the review of withdrawal periods for Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products

Reference Number: EMA/42905/2021

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)