Senstend

Withdrawn

This medicine's authorisation has been withdrawn

lidocaine / prilocaine

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The European Public Assessment Report (EPAR) for Senstend is updated to indicate that the marketing authorisation is no longer valid.

Senstend : EPAR - Medicine overview

Reference Number: EMA/519240/2019

Senstend : EPAR - Risk-management-plan summary

Product information

Senstend : EPAR - Product information

Senstend : EPAR - All authorised presentations

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

Anesthetics

Therapeutic indication

Senstend is indicated for the treatment of primary premature ejaculation in adult men.

Authorisation details

• EMA product number:
  EMEA/H/C/005298
• Marketing authorisation holder:
  Plethora Pharma Solutions Limited

  32 Merrion Street; Upper Dublin 2; Ireland

• Opinion adopted:
  19/09/2019
• Marketing authorisation issued:
  14/11/2019

Assessment history

Initial marketing authorisation documents

Senstend : EPAR - Public assessment report

Adopted Reference Number: EMA/625405/2019

CHMP summary of positive opinion for Senstend

Adopted Reference Number: EMA/CHMP/382383/2019