Gentamicin - referral

Current status

European Commission final decision

Overview

Gentamicin is an aminoglycoside antibiotic indicated for the treatment of a variety of bacterial infections. It is normally used as the sulphate salt. In veterinary medicine gentamicin is used mainly as a solution for injection for pigs, cattle and horses and as an oral solution for poultry. It is also used in human medicine, usually as a solution for injection for intramuscular administration. It is currently included in the list of essential medicines for human use of the World Health Organisation (WHO).

On 14 February 2014, Denmark presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses. The CVMP was requested to harmonise the indications and dosing regimens of the concerned products, taking into account the available data and in particular with regard to the target animal safety.

The referral started on 12 March 2014. The Committee appointed K. Baptiste as rapporteur and
C. Muñoz Madero as co-rapporteur. Written explanations were provided by the applicants and marketing authorisation holders on 16 May 2014 and 4 September 2014.

Based on the evaluation of the currently available data, the CVMP considered that the overall benefit-risk profile for these products remains positive subject to amendments in the product information. Therefore, on 6 November 2014 the Committeeadopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.

The final opinion was converted into a Decision by the European Commission on 11 February 2015.

Gentamicin Article 35 - Opinion following an Article 35 referral for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses: Background information

AdoptedReference Number: EMA/106359/2015

Key facts

About this medicine

• Approved name:
  Gentamicin
• International non-proprietary name (INN) or common name:
  gentamicin
• Class:
  Aminoglycosides

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/104
• 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:
  06/11/2014
• EC decision date:
  11/02/2015

All documents

European Commission final decision

Gentamicin Article 35 - Veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses: Annex I, II, III

Adopted

Gentamicin Article 35 - Opinion following an Article 35 referral for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses: Background information

AdoptedReference Number: EMA/106359/2015

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)