Senstend

Withdrawn

This medicine's authorisation has been withdrawn

lidocaine / prilocaine

Overview

The marketing authorisation for Senstend has been withdrawn at the request of the marketing-authorisation holder.

Senstend : EPAR - Medicine overview

Reference Number: EMA/519240/2019

Senstend : EPAR - Risk-management-plan summary

Product information

Senstend : EPAR - 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).

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

AdoptedReference Number: EMA/625405/2019

CHMP summary of positive opinion for Senstend

AdoptedReference Number: EMA/CHMP/382383/2019