Equibactin vet.

Table of contents

Current status
European Commission final decision

Overview

Equibactin vet. is a paste for oral use containing trimethoprim and sulfadiazine as active ingredients and is indicated for treatment of infections in horses caused by bacteria sensitive to the combination of trimethoprim and sulfadiazine, particularly:

  • Respiratory tract infections associated with Streptococcus spp. and Staphylococcus aureus;
  • Gastrointestinal infections associated with E. coli;
  • Urogenital infections associated with beta-hemolytic streptococci;
  • Wound infections and open or drained abscesses associated with Streptococcus spp. and Staphylococcus aureus.

Equibactin vet. is a generic product.

In August 2006 a decentralised procedure started with The Netherlands as Reference Member State and 17 Concerned Member States.

France could not agree to the granting of a marketing authorisation as it considered there were potential serious risks to animal health. The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the CVMP.

France considered that the dosing regime of the product is not correct. It considered this may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.

The CVMP started the referral procedure during its meeting of 6-8 November 2007. The Marketing Authorisation Holder was requested to provide a copy of the dossier and, in view of the concerns raised by France, to indicate and to substantiate where necessary, any differences between Equibactin vet. and the reference product Tribrissen Oral Paste that could justify different conclusions on the safety or efficacy.

In response to the questions, the applicant submitted the dossier and argued on the basis of a comparison of compositions and pharmacokinetic data, that there are no differences between Equibactin vet. and the reference product that would justify different conclusions on the safety and
efficacy for the two products.

CVMP agreed that Equibactin vet. proved to be essentially similar to reference product Tribrissen Oral Paste. Therefore the same conclusions on efficacy and safety apply equally to both products and the objections raised by France should not prevent the granting of a marketing authorisation.

Being aware of a referral ongoing at the time under Article 35 of Directive 2001/82/EC, as amended, for reference product Tribrissen Oral Paste, CVMP recommended that the outcome of that referral procedure (EMEA/V/023) should apply to the marketing authorisation of Equibactin vet.

The CVMP Opinion was adopted on 12 December 2007 and the subsequent Commission Decision on 3 March 2008.

Key facts

Approved name
Equibactin vet.
International non-proprietary name (INN) or common name
  • trimethoprim
  • sulfadiazine
Current status
European Commission final decision
Reference number
CVMP/455918/08
Type
Article 33

Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure.
Opinion date
12/12/2007
EC decision date
03/03/2008

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