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

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
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.

Status
European Commission final decision
Opinion date
10/11/2016
EC decision date
27/02/2017

All documents

Document description

  • Opinion - contains the CVMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents may not always be available:

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