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 |
|
| Associated names |
Foresto
|
| Current status |
European Commission final decision
|
| 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). |
| 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 -
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)