Zanil and associated names, and generic products thereof - referral

Current status

European Commission final decision

Overview

On 13 July 2017, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods (meat, milk and offal) for cattle, sheep and goats for Zanil and associated names, and generic products thereof. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the concerned products is positive and recommended amendments to withdrawal periods for cattle, sheep and goats to provide assurance for consumer safety.

What are Zanil and associated names, and generic products thereof?

The veterinary medicinal products Zanil and associated names, and generic products thereof, are oral suspensions containing 34 mg oxyclozanide per ml. Oxyclozanide is a salicylanilide anthelmintic, used for the treatment of fasciolosis in cattle, sheep and goats and also for elimination of gravid tapeworm segments (Moniezia spp).

Why were Zanil and associated names, and generic products thereof reviewed?

France noted that across the European Union for Zanil and associated names, and generic products thereof, there are different approved withdrawal periods for cattle, sheep and goats, e.g. cattle meat and offal from 10 days to 28 days; cattle milk from zero hours to 108 hours; sheep meat and offal from 14 days to 28 days; sheep milk from 'do not use in sheep producing milk for human consumption' to 7 days; goat meat and offal 14 days; goat milk zero days.

Consequently, on 1 September 2016, France initiated a procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products. The CVMP was requested to review all available residue depletion data and recommend withdrawal periods for milk, meat and offal derived from treated cattle, sheep and goats.

Which data has the CVMP reviewed?

Proprietary data and scientific references on residue depletion were provided by the marketing authorisation holders.

What are the conclusions of the CVMP?

Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefit-risk balance for Zanil and associated names, and generic products thereof, is positive and agreed that the withdrawal periods (meat, milk and offal) for cattle, sheep and goats should be amended to provide assurance for consumer safety. The CVMP recommended that variations to the terms of the marketing authorisations for the aforementioned veterinary medicinal products are required in order to amend the product information accordingly.

The European Commission issued a decision on 28 September 2017.

Zanil Article-35 referral - Questions and answers on Zanil and associated names, and generic products thereof

Reference Number: EMA/586006/2017Summary:

Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/124)

Key facts

About this medicine

• Approved name:
  Zanil and associated names, and generic products thereof
• International non-proprietary name (INN) or common name:
  oxyclozanide
• Associated names:
  • Zanil Suspension
  • Zanil Fluke Drench
  • Zanil Fluke Drench 34 mg/ml Oral Suspension

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/124
• Type:
  Article 35

  Community interest referral: initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

Key dates and outcomes

• Opinion date:
  13/07/2017
• EC decision date:
  28/09/2017

All documents

European Commission final decision

Zanil Article-35 referral - Annex I, II, III

Zanil Article-35 referral - Questions and answers on Zanil and associated names, and generic products thereof

Reference Number: EMA/586006/2017Summary:

Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/124)

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)