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.
Nisamox Lactating Cow
|International non-proprietary name (INN) or common name||
amoxicillin / clavulanic acid / prednisolone
Nisamox Lactating Cow
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 referral for Nisamox Lactating Cow and associated names: Background information (PDF/56.94 KB)Adopted
First published: 08/12/2011
Last updated: 08/12/2011
- 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