Suramox 15 % LA and its associated name Stabox 15 % LA
Suramox 15% LA is an injectable suspension containing amoxicillin, which is a beta-lactam antibiotic belonging to the penicillin group. The product is used in the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs. In both species the product is administered intramuscularly at a dose of 15 mg amoxicillin/kg bw (equivalent to 1 ml of Suramox 15% LA / 10 kg bw) twice with a 48 hour interval between doses.
A Marketing Authorisation for Suramox 15% LA was previously granted to Virbac S.A. in France on 6 July 2004 based on an abridged application citing Duphamox LA as reference medicinal product. The withdrawal periods established for Suramox 15% LA were 58 days in cattle for meat and offal and 35
days in pigs for meat and offal. The withdrawal period for milk was 2.5 days.
A mutual recognition procedure was started on 28 April 2005. The Reference Member State was France and the Concerned Member States were Belgium, the Czech Republic, Germany, Italy, Spain and the United Kingdom. The product was accepted by the Czech Republic, Italy and Spain. Concerns were raised by Belgium, Germany and the United Kingdom regarding the inadequacy of the withdrawal periods and the applications were withdrawn from these countries. Belgium referred the issue to the EMEA on 28 July 2005.
The scope of the referral was to agree whether the proposed withdrawal periods of 58 days for cattle and 35 days for pigs were adequately established.
The arbitration procedure started on 8 September 2005 with the adoption of a list of questions. The rapporteur was Mr. J. Schefferlie and the co-rapporteur was Prof. R. Kroker. The Marketing Authorisation Holder (MAH) subsequently provided written explanations to the Committee on 16 January 2006.
During its May 2006 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion recommending the suspension of the marketing authorisations for Suramox 15% LA and the Stabox 15% LA, for cattle and pigs. The reasons being the following:
- it was not possible to establish a withdrawal period for cattle and pigs based on the data available; 1 Article 35 of Directive 2001/82/EC, as amended
- the currently established withdrawal periods for cattle and pigs are inadequate to ensure that residues do not exceed the MRLs;
- the currently authorised withdrawal periods are inadequate to ensure that foodstuffs obtained from treated animals do not contain residues which might constitute a health hazard to the consumer.
On 1 June 2006, the MAH notified the EMEA of its intention to request the reexamination of the CVMP opinion in accordance with Article 36(4)2. During its June 2006 meeting, the CVMP appointed Dr. R. Breathnach as rapporteur for the assessment of the grounds for the request for re-examination of the opinion. The detailed grounds for the request were submitted to the EMEA on 18 July 2006 and the evaluation procedure for the re-examination started on 19 July 2006.
On 13 September 2006 the CVMP considered the detailed grounds for the re-examination of the opinion and confirmed its previous opinion concluding that the marketing authorisations for Suramox 15% LA should be suspended. The reasons for the suspension were the same as those identified in the May 2006 CVMP meeting.
On 25 October 2006 the European Commission forwarded a draft decision to the Standing Committee on Veterinary Medicinal Products for adoption by written procedure. During the written procedure a request was received from France for a scientific assessment of new studies made available by the Marketing Authorisation Holder.
On 14 November 2006 the European Commission suspended the written procedure and on 16 November 2006, requested the CVMP to consider the new residue studies in the assessment of the referral and to revise as appropriate the opinion of 13 September 2006.
The Marketing Authorisation Holder submitted the new residue studies to the CVMP on 9 January 2007 and provided oral explanations to the Committee on 13 March 2007.
On 14 March 2007 the CVMP, having considered the new residue studies, concluded that it was not possible to set a withdrawal period for Suramox 15% LA and Stabox 15% LA, for either cattle or pig meat and offal and therefore recommended by consensus the suspension of the above marketing authorisations for the above-mentioned products.
On 13 June 2007 the European Commission adopted a Commission Decision suspending the national marketing authorisations for Suramox 15% LA and Stabox 15% LA, but providing an opportunity for the decision to be reviewed further to a new opinion formulated by the CVMP on the basis of the assessment of new residue depletion studies.
The Marketing Authorisation Holder submitted further new residue studies to the CVMP on 14 April 2008. The procedure for evaluation of the new data started on 15 April 2008. The rapporteur was Mrs. R. Kearsley and the co-rapporteur was Prof. C. Friis.
During its June 2008 meeting the CVMP considered the new residue studies submitted with regard to Suramox 15% LA and concluded that withdrawal periods can now be set for both cattle and pigs for Suramox 15% LA and Stabox 15% LA. Therefore, the Committee adopted by consensus an opinion recommending the lifting of the suspension of the marketing authorisations for the above-mentioned product.
Furthermore, the Committee recommends varying the marketing authorisations of the veterinary medicinal products referred to in Annex I in accordance with the Summary of Product Characteristics (SPC) as set out in Annex III.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the SPC in Annex III.
The final opinion was converted into a Decision by the European Commission on 5 September 2008.
Suramox 15 % LA and its associated name Stabox 15 % LA
|International non-proprietary name (INN) or common name||
Stabox 15% LA
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.
European Commission final decision
|EC decision date||
Follow-up opinion following an Article 35 referral for Suramox 15 % LA and its associated name Stabox 15 % LA International Non-Proprietary Name (INN): Amoxicillin: Background information (PDF/30.47 KB)Adopted
First published: 06/09/2008
Last updated: 06/09/2008
Suramox 15 % LA and its associated name Stabox 15 % LA - Article 35 Referral - Annex I, II, III (PDF/130.49 KB)Adopted
First published: 16/10/2008
Last updated: 16/10/2008
- 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