Senstend
Withdrawn
This medicine's authorisation has been withdrawn
lidocaine / prilocaine
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 24 June, the European Commission withdrew the marketing authorisation for Senstend (lidocaine / prilocaine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Plethora Pharma Solutions Limited, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Senstend was granted marketing authorisation in the EU on 14 November 2019 for the treatment of primary premature ejaculation. The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU since its approval in 2019. Senstend was a duplicate application to Fortacin, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Fortacin.
The European Public Assessment Report (EPAR) for Senstend is updated to indicate that the marketing authorisation is no longer valid.
Product information
14/11/2019
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Senstend
- Active substance
- lidocaine
- prilocaine
- International non-proprietary name (INN) or common name
- lidocaine
- prilocaine
- Therapeutic area (MeSH)
- Premature Ejaculation
- Anatomical therapeutic chemical (ATC) code
- N01BB20
Pharmacotherapeutic group
AnestheticsTherapeutic indication
Senstend is indicated for the treatment of primary premature ejaculation in adult men.
News on Senstend
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