Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof - referral

Current status

European Commission final decision

Overview

On 16 July 2020, the European Medicines Agency (the Agency) completed a review of the withdrawal periods (meat and offal) for pigs for Stresnil 40 mg/ml solution for injection and associated names, and generic products thereof. 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 maximum injection volume per site and the withdrawal periods for pigs should be changed to provide assurance for consumer safety.

What are Stresnil and its generics?

The veterinary medicines Stresnil and its generics are injectable solutions containing 40 mg azaperone per ml. Azaperone is a sedative used in pigs for the treatment of aggressive behaviour, control of aggression in sows, prevention of stress, obstetric conditions, as pre-medication in local or general anaesthesia and for palliative treatment of enzootic muscular dystrophy. Veterinary medicines containing azaperone can be used in pigs by injection into the muscle.

Why were Stresnil and its generics reviewed?

On 17 September 2019, the German veterinary medicines authority requested that the CVMP review all available data and recommend withdrawal periods for meat and offal from pigs treated with Stresnil and its generics.

The German authority considered that the withdrawal periods for pigs in the European Union (EU) might not be adequate to ensure consumer safety, noting that they differed across the EU, ranging from 7 to 18 days.

Consequently, the German authority asked the CVMP to carry out a full assessment of the benefit-risk balance of Stresnil and its generics, and to issue an opinion on whether the marketing authorisations for the above-mentioned products should be maintained, varied, suspended or withdrawn across the EU.

Which data has the CVMP reviewed?

The CVMP reviewed available data on residue depletion in pigs for the veterinary medicines Stresnil and its generics, 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 Stresnil and its generics continue to outweigh the risks. The CVMP recommended that the withdrawal period for meat and offal from pigs treated with these veterinary medicines should be 18 days, with a limit to the injection volume of 5 ml for the protection of consumer safety.

The Committee recommended the variation to the terms of the marketing authorisations 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 12 October 2020.

Questions and answers on the review of withdrawal periods for Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof

Reference Number: EMA/460836/2020 Summary:

Outcome of a procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/138)

Key facts

About this medicine

• Approved name:
  Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof
• International non-proprietary name (INN) or common name:
  azaperone

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/138
• 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:
  Nationally authorised product(s)

Key dates and outcomes

• Opinion date:
  16/07/2020
• EC decision date:
  12/10/2020

All documents

European Commission final decision

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

Questions and answers on the review of withdrawal periods for Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof

Reference Number: EMA/460836/2020 Summary:

Outcome of a procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/138)

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)