Dectomax injectable solution and its associated names
Table of contents
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 |
|
| Current status |
European Commission final decision
|
| 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. |
| Opinion date |
08/12/2004
|
| EC decision date |
29/03/2005
|
All documents
-
List item
Opinion following an article 34 referral for Dectomax injectable solution and its associated names (PDF/74.85 KB)
First published: 13/08/2014
Last updated: 13/08/2014
EMA/249887/2014 -
List item
Dectomax injectable solution Article-34 referral - Annex I, II (PDF/130.14 KB)
First published: 13/08/2014
Last updated: 13/08/2014 -
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)