Nisamox Lactating Cow - referral

Current status

European Commission final decision

Overview

Nisamox Lactating Cow Intramammary Suspension is an intramammary suspension containing amoxicillin, clavulanic acid and prednisolone. Nisamox is intended for the treatment of mastitis in lactating cows.

The marketing authorisation holder, Norbrook Laboratories Ltd, submitted an application for Nisamox via a mutual recognition procedure in the Netherlands on the basis of the marketing authorisation granted by the United Kingdom. The application was submitted as a generic of the reference product, Synulox Lactating Cow Intramammary Suspension marketed by Pfizer Ltd. The mutual recognition procedure (UK/V/0355/001/MR) started on 26 November 2009.

On 2 July 2010, the United Kingdom, as reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by the Concerned Member State, the Netherlands, that the safety and efficacy of the product had not been sufficiently demonstrated. There was disagreement between the Reference Member State and Concerned Member State on the demonstration of bioequivalence and the adequacy of the proposed withdrawal period.

The referral procedure started on 14 July 2010. The Committee appointed Mr Johan Schefferlie 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 holder on 13 September 2011 and 10 March 2011. Oral explanations were given on 12 January 2011.

Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Nisamox Lactating Cow Intramammary Suspension is negative, and therefore adopted an opinion on 6 April 2011 recommending the refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisation.

Nine CVMP members expressed divergent positions, which are appended to the opinion.

The list of product names concerned is given in Annex I. The scientific conclusions and the grounds for refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisation are provided in Annex II. The grounds for the lifting of the suspension of the marketing authorisation are provided in Annex III.

The final opinion was converted into a Decision by the European Commission on 5 August 2011.

Opinion following an Article 33 referral for Nisamox Lactating Cow and associated names: Background information

Adopted Reference Number: EMEA/V/A/62

Key facts

About this medicine

• Approved name:
  Nisamox Lactating Cow
• International non-proprietary name (INN) or common name:
  • amoxicillin
  • clavulanic acid
  • Prednisolone
• Associated names:
  Nisamox Lactating Cow

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMA/V/A/062
• Type:
  Article 33 referrals (prior to January 2022)

  This type of referral is initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure.

Key dates and outcomes

• Opinion date:
  06/04/2011
• EC decision date:
  05/08/2011

All documents

Opinion following an Article 33 referral for Nisamox Lactating Cow and associated names: Background information

Adopted Reference Number: EMEA/V/A/62

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)