Seresto and its associated name Foresto

Current status
European Commission final decision


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
  • flumethrin
Associated names
Current status
European Commission final decision
Reference number
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
EC decision date

All documents

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 characteristicslabelling 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)

How useful was this page?

Add your rating
3 ratings
2 ratings
6 ratings