Methylprednisolone injection for cattle - referral

Current status

European Commission final decision

Overview

On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods for cattle (meat and offal) for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection.

The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in the absence of appropriate residue depletion data, a withdrawal period for meat and offal derived from treated cattle cannot be set. The CVMP recommended the refusal of the granting of a marketing authorisation for the target species cattle and variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate.

What is methylprednisolone hydrogen succinate?

Methylprednisolone hydrogen succinate is an ester of the synthetic glucocorticoid methylprednisolone. Veterinary medicinal products containing methylprednisolone hydrogen succinate are used for treatment of inflammatory or allergic conditions and also for treatment and prevention of shock conditions.

Why were veterinary medicinal products containing methylprednisolone hydrogen succinate reviewed?

Germany considered that the withdrawal period of 6 days for cattle (meat and offal) treated with methylprednisolone hydrogen succinate-containing products might not be sufficient to ensure consumer safety.

On 2 May 2016, Germany initiated a referral procedure under Article 35 of Directive 2001/82/EC for the aforementioned products. The CVMP was requested to review all available residue depletion data and to recommend withdrawal periods for meat and offal derived from treated cattle.

Which data has the CVMP reviewed?

In the absence of product-specific residue depletion data or any other information concerning residues of veterinary medicinal products containing methylprednisolone hydrogen succinate, the CVMP considered the available residue depletion data used for the establishment of maximum residue limits for methylprednisolone (EMEA/MRL/798/01)¹.

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¹Methylprednisolone: Summary report (2) - Committee for Veterinary Medicinal Products

What are the conclusions of the CVMP?

Based on the evaluation of the currently-available data, the CVMP concluded that the benefit-risk balance for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection is not favourable in the absence of adequate residue depletion data to justify a withdrawal period of 6 days for cattle (meat and offal). The CVMP recommended the refusal of the granting of a marketing authorisation for the target species cattle and variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection.

The European Commission issued a decision on 20 June 2017.

Methylprednisolone Article-35 referral - Questions and answers on veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for use in the target species cattle

Reference Number: EMA/398380/2017Summary:

Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/119)

Key facts

About this medicine

• Approved name:
  Methylprednisolone injection for cattle
• International non-proprietary name (INN) or common name:
  methylprednisolone hydrogen succinate

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/119
• 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:
  16/03/2017
• EC decision date:
  20/06/2017

All documents

European Commission final decision

Methylprednisolone Article-35 referral - Annexes I, II, III, IV

Methylprednisolone Article-35 referral - Questions and answers on veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for use in the target species cattle

Reference Number: EMA/398380/2017Summary:

Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/119)

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)