Seresto and its associated name Foresto
Table of contents
Current status:
European Commission final decision
Overview
Questions and answers on Seresto and its associated name Foresto
Outcome of a procedure under Article 13 of Regulation (EC) No 1234/2008
On 15 February 2018, the European Medicines Agency (the Agency) completed an arbitration procedure for Seresto and its associated name Foresto. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the change to the marketing authorisation for Seresto to add a new indication can be granted.
Key facts
Approved name |
Seresto and its associated name Foresto
|
International non-proprietary name (INN) or common name |
imidacloprid and flumethrin |
Associated names |
Foresto
|
Reference number |
EMEA/V/A/125
|
Type |
Article 13
This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II). |
Status |
European Commission final decision
|
Opinion date |
15/02/2018
|
EC decision date |
25/05/2018
|
All documents
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List item
Seresto Article-13 referral - Questions and answers on Seresto and its associated name Foresto (PDF/77.05 KB)
First published: 10/07/2018
Last updated: 10/07/2018
EMA/392857/2018 -
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List item
Seresto Article-13 referral - Annex I, II, III (PDF/194.48 KB)
First published: 10/07/2018
Last updated: 10/07/2018 -
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