Suvaxyn Parvo/E
Table of contents
Overview
France notified the EMEA on 11 July 2006 of a Referral under Article 40 of Council Directive 2001/82/EC, as amended, in relation to Suvaxyn Parvo/E.
Suvaxyn Parvo/E is indicated for the active immunisation of pigs (gilts and sows) to prevent reproductive disorders caused by porcine parvovirus and to reduce clinical signs caused by Erysipelothrix rhusiopathiae infections, serotype 2 and serotype 1.
The referral deals with the issue that in the opinion of France equivalence between the reference vaccine batch for the erysipelas batch potency test validated in the original dossier and the new reference vaccine batches was not shown for these 2 batches and that consequently the CVMP needed to consider whether to vary, withdraw or suspend the marketing authorisation.
The Committee for Medicinal Products for Veterinary Use (CVMP) started the referral procedure on 19 July 2006.
The CVMP concluded that, based on all available data, there was no concern regarding safety or efficacy for the product. However, it was important to ensure that the pass limits of the potency test do not drift from the original. In addition, a more robust test for potency should be applied to the product in the future.
The CVMP, therefore, recommended that the Marketing Authorisation should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum.
The CVMP Opinion was adopted on 17 January 2007 and the subsequent Commission Decision on 17 April 2007.
Key facts
| Approved name |
Suvaxyn Parvo/E
|
| Current status |
European Commission final decision
|
| Reference number |
CVMP/532267/07
|
| Type |
Articles 39 and 40
Follow-up referral. |
| Opinion date |
17/01/2007
|
| EC decision date |
17/04/2007
|
All documents
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List item
Opinion following an Article 40 referral for Suvaxyn Parvo/E: Background information (PDF/28.88 KB)
Adopted
First published: 02/06/2008
Last updated: 02/06/2008
EMEA/532267/2007- Rev.1 -
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List item
Suvaxyn Parvo/E - Article 40 Referral - Annex I, II (PDF/45.15 KB)
Adopted
First published: 16/11/2007
Last updated: 16/11/2007 -
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)