Senstend
lidocaine / prilocaine
Table of contents
Overview
Senstend is a medicine containing the active substances lidocaine and prilocaine. It is used to treat men with primary (lifelong) premature ejaculation (when ejaculation regularly occurs before, or too early during, penetration).
This medicine is the same as Fortacin, which is already authorised in the EU. The company that makes Fortacin has agreed that its scientific data can be used for Senstend (‘informed consent’).
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Senstend : EPAR - Medicine overview (PDF/108.59 KB)
First published: 29/11/2019
EMA/519240/2019 -
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Senstend : EPAR - Risk-management-plan summary (PDF/67.73 KB)
First published: 29/11/2019
Authorisation details
Product details | |
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Name |
Senstend
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Agency product number |
EMEA/H/C/005298
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Premature Ejaculation
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Anatomical therapeutic chemical (ATC) code |
N01BB20
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Publication details | |
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Marketing-authorisation holder |
Plethora Pharma Solutions Limited
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Date of issue of marketing authorisation valid throughout the European Union |
14/11/2019
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Contact address |
Product information
14/11/2019 Senstend - EMEA/H/C/005298 -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Anesthetics
Therapeutic indication
Senstend is indicated for the treatment of primary premature ejaculation in adult men.