Dectomax injectable solution and its associated names

Current status:
European Commission final decision

Overview

Dectomax injectable solution and its associated names contain doramectin as an active substance at 10 mg per ml. Doramectin is a semi-synthetic compound of the avermectin family, intended for the treatment of internal and external parasites in cattle, sheep, pigs and reindeer.

Due to divergent national decisions taken by Member States concerning the marketing authorisations of Dectomax injectable solution and its associated names, on 27 January 2004 the United Kingdom referred the issue to the CVMP under Article 34 of Directive 2001/82/EC, in order to resolve discrepancies regarding the withdrawal period for sheep meat and offal across the European Union.

The referral procedure started on 11 February 2004. The Committee appointed C. Friis as rapporteur and J. G. Beechinor as co-rapporteur.

Written explanations were provided by the marketing authorisation holders on 17 June 2004.

Based on the evaluation of the available data, the CVMP considered that for Dectomax injectable solution and its associated names a withdrawal period of 70 days for sheep meat and offal should be recommended. With respect to the subcutaneous use in sheep, the CVMP concluded that no withdrawal period could be set and references to this route of administration should be removed from the product information. Therefore, the CVMP adopted an opinion on 7 September 2004 for the above-mentioned product.

On 17 September 2004 the marketing authorisation holder notified the Agency of their intention to request a re-examination of the CVMP opinion of 7 September 2004.

During its October 2004 meeting the CVMP appointed H. Hoogland as rapporteur and M. Arboix as co-rapporteur for the re-examination procedure.

The detailed grounds for the re-examination were submitted on 8 November 2004. The re-examination procedure started on 8 November 2004.

On 8 December 2004, the CVMP adopted an opinion confirming the recommendation for 70 days withdrawal period for sheep meat and offal and the removal of subcutaneous route of administration in sheep.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.

The final opinion was converted into a Decision by the European Commission on 29 March 2005.

Key facts

Approved name
Dectomax injectable solution and its associated names
International non-proprietary name (INN) or common name
doramectin
Associated names
  • Dectomax 1% Injektionslösung für Rinder und Schafe
  • Dectomax Vet
  • Dectomax 1%
  • Dectomax 1% Injectable Solution
  • Prontax
  • Dectomax solution injectable
  • Dectomax Injectable Solution for Cattle and Sheep
Reference number
EMEA/V/A/009
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.

Status
European Commission final decision
Opinion date
08/12/2004
EC decision date
29/03/2005

All documents

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:

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