Bovimectin Injection and its associated names
Table of contents
Overview
Bovimectin Injection and its associated names are solutions for injection and contain ivermectin as active substance. They are intended for use in cattle as a subcutaneous injection for the treatment and prevention of infestations by gastro-intestinal roundworms, lungworms, eyeworms, warbles, mange mites and sucking lice.
The marketing authorisation holder, Cross Vetpharm Group Ltd, submitted an application via mutual recognition for Bovimectin Injection, on the basis of the marketing authorisation granted by Ireland. This is a generic application referring to the reference product Panomec. The reference Member State is Ireland and Belgium is concerned Member State.
The mutual recognition procedure started on 23 November 2001. Potential serious risks were identified during the mutual recognition procedure by Belgium regarding the demonstrated bioequivalence with the reference product.
On 21 February 2002, in view of the remaining unsolved issues Belgium submitted a referral notification under Article 33 of Directive 2001/82/EC to the CVMP.
The referral procedure started on 12 March 2002. The Committee appointed C. Friis as rapporteur and M. Arboix as co-rapporteur. Written explanations were provided by the marketing authorisation holder on 11 April 2002.
Based on the evaluation of the available data, the CVMP considered that the objections raised by Belgium during the mutual recognition procedure should not prevent the granting of a marketing authorisation for Bovimectin Injection and its associated names. Therefore, the Committee adopted by majority a positive opinion on 12 June 2002 recommending the granting of the marketing authorisation the above-mentioned product.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
The opinion was converted into a Decision by the European Commission on 12 September 2002.
Key facts
| Approved name |
Bovimectin Injection and its associated names
|
| International non-proprietary name (INN) or common name |
ivermectin
|
| Associated names |
Bovimec B
|
| Reference number |
EMEA/V/A/002
|
| Type |
Article 33
Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure. |
| Status |
European Commission final decision
|
| Opinion date |
12/06/2002
|
| EC decision date |
19/09/2002
|
All documents
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List item
Opinion following an article 33 referral for Bovimectin Injection and its associated names (PDF/74.35 KB)
First published: 13/08/2014
Last updated: 13/08/2014
EMA/76071/2014 -
List item
Bovimectin Injection Article-33 referral - Annex I, II, III (PDF/123.6 KB)
First published: 13/08/2014
Last updated: 13/08/2014 -
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List item
Divergent position regarding the referral for arbitration under Article 33 of Directive 2001/82/EC submitted for Bovimec B and Porcimec P (PDF/14.68 KB)
First published: 13/08/2014
Last updated: 13/08/2014
EMA/76071/2014
Document description
- 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