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.
|International non-proprietary name (INN) or common name||
trimethoprim and sulfadiazine
Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure.
European Commission final decision
|EC decision date||
Opinion following an Article 33(4) referral for Equibactin vet.: Background information (PDF/30.32 KB)Adopted
First published: 02/06/2008
Last updated: 02/06/2008
Equibactin vet. - Article 33 Referral - Annex I, II, III (PDF/19.22 KB)Adopted
First published: 10/10/2008
Last updated: 10/10/2008
- 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:
- Changes to the summary of product characteristics, labeling or package leaflet ('annex III') - available when changes have been recommended by the Committee
- Conditions of the marketing authorisation (Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies