Veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs

Table of contents

Current status
European Commission final decision

Overview

Questions and answers on veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs

Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/117)

On 10 November 2016, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods for cattle (meat and milk) and pigs (meat and offal) for veterinary medicinal products containing gentamicin presented as solutions for injection. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for veterinary medicinal products containing gentamicin presented as solutions for injection is positive and recommended amendments to withdrawal periods for cattle and pigs to provide assurance for consumer safety.

Key facts

Approved name
Veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs
International non-proprietary name (INN) or common name
gentamicin
Current status
European Commission final decision
Reference number
EMEA/V/A/117
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.
Opinion date
10/11/2016
EC decision date
27/02/2017

All documents

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)

How useful was this page?

Add your rating