Synulox Lactating Cow - referral

Current status

European Commission final decision

Overview

Amoxicillin is a broad spectrum bactericidal β-lactam antibiotic. Clavulanic acid inactivates β-lactamases. This combination is effective against β-lactamase producing organisms. Prednisolone is an anti-inflammatory corticosteroid. Synulox Lactating Cow and associated names is a 3 g pale cream/buff coloured oily suspension presented in disposable intramammary syringes containing 200 mg amoxicillin as amoxicillin trihydrate, 50 mg clavulanic acid as potassium clavulanate and 10 mg prednisolone. The product is intended for the treatment of bovine clinical mastitis in lactating cows.

Due to the divergent national decisions taken by Member States concerning the authorisation of Synulox Lactating Cow and associated names and differences between the summary of product characteristics (SPC) of the product as authorised in the Member States, the issue was referred on 26 March 2010 by Belgium and Denmark to the CVMP under Article 34(1) of Directive 2001/82/EC.

The reason for divergent national decisions regarding the authorisation of the products was mainly the justification of the combination of amoxicillin/clavulanic acid/prednisolone for the treatment of bovine mastitis. The main sections of disharmony of the existing SPCs related to indications, posology and withdrawal periods.

The referral procedure started on 14 April 2010. The Committee appointed Dr Bruno Urbain as rapporteur and Mrs Ruth Kearsley as co-rapporteur. Further to the resignation of Mrs Ruth Kearsley as CVMP member, Ms Helen Jukes was appointed to replace her and took over the co-rapporteurship. Written explanations were provided by the marketing authorisation holders on 18 August 2010 and 8 February 2011. Oral explanations were given on 4 May 2011.

Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the benefit/risk profile for Synulox Lactating Cow and associated names remains positive subject to variation of the marketing authorisations in accordance with the summary of product characteristics, and therefore adopted a positive opinion on 7 June 2011.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics in Annex III.

The final opinion was converted into a Decision by the European Commission on 20 October 2011.

Opinion following an Article 34 referral for Synulox Lactating Cow and associated names: Background information

AdoptedReference Number: EMA/512798/2011

Key facts

About this medicine

• Approved name:
  Synulox Lactating Cow
• International non-proprietary name (INN) or common name:
  • amoxicillin trihydrate
  • potassium clavulanate
  • Prednisolone
• Associated names:
  • Avuloxil
  • Synulox LC
  • Synulox comp. vet
  • Synulox Endomammario

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMA/512798/2011
• Type:
  Article 34

  Divergent decision referral: initiated in order to obtain harmonisation within the EU of the conditions of authorisation for products already authorised by Member States.

Key dates and outcomes

• Opinion date:
  07/06/2011
• EC decision date:
  20/10/2011

All documents

Synulox Lactating Cow: Article 34 referral - Annex I, II, III

Adopted

Opinion following an Article 34 referral for Synulox Lactating Cow and associated names: Background information

AdoptedReference Number: EMA/512798/2011

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)