Senstend

RSS
Withdrawn

This medicine's authorisation has been withdrawn

lidocaine / prilocaine
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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The marketing authorisation for Senstend has been withdrawn at the request of the marketing-authorisation holder.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

English (EN) (670.21 KB - PDF)

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български (BG) (1.29 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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español (ES) (1.22 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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čeština (CS) (1.27 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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dansk (DA) (1.22 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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Deutsch (DE) (1.22 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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eesti keel (ET) (1.21 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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ελληνικά (EL) (1.28 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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français (FR) (1.22 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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hrvatski (HR) (1.24 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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italiano (IT) (686.49 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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latviešu valoda (LV) (752.95 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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lietuvių kalba (LT) (711.1 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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magyar (HU) (1.27 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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Malti (MT) (747.25 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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Nederlands (NL) (687.46 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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polski (PL) (744.53 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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português (PT) (688.19 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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română (RO) (708.86 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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slovenčina (SK) (743.36 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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slovenščina (SL) (701.62 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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Suomi (FI) (1.21 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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svenska (SV) (666.47 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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Senstend : EPAR - Risk-management-plan summary

English (EN) (1.21 MB - PDF)

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Product information

Senstend : EPAR - Product information

English (EN) (938.11 KB - PDF)

First published: Last updated:
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български (BG) (1.64 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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español (ES) (1.66 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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čeština (CS) (1.37 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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dansk (DA) (914.89 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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Deutsch (DE) (1.01 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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eesti keel (ET) (985.34 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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ελληνικά (EL) (1.71 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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français (FR) (926.09 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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hrvatski (HR) (831.74 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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íslenska (IS) (806.43 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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italiano (IT) (917.55 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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latviešu valoda (LV) (1.46 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

lietuvių kalba (LT) (1.01 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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magyar (HU) (882.02 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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Malti (MT) (1.42 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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Nederlands (NL) (917.64 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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norsk (NO) (989.64 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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polski (PL) (1.45 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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português (PT) (993.24 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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română (RO) (1.02 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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slovenčina (SK) (1.43 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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slovenščina (SL) (1.46 MB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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Suomi (FI) (993.89 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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svenska (SV) (919.07 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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14/11/2019
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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

English (EN) (618.59 KB - PDF)

First published: Last updated:
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български (BG) (690.65 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

español (ES) (619.32 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

čeština (CS) (680 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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dansk (DA) (619.86 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

Deutsch (DE) (620.79 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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eesti keel (ET) (618 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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ελληνικά (EL) (687.72 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

français (FR) (620.68 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

hrvatski (HR) (662.45 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

íslenska (IS) (826.65 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

italiano (IT) (619.23 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

latviešu valoda (LV) (681.09 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

lietuvių kalba (LT) (663.74 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

magyar (HU) (678.77 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

Malti (MT) (681.6 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

Nederlands (NL) (617.33 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

norsk (NO) (619.89 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

polski (PL) (680.16 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

português (PT) (619.33 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

română (RO) (663.19 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

slovenčina (SK) (679.4 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
View

slovenščina (SL) (676.69 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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Suomi (FI) (617.2 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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svenska (SV) (619.13 KB - PDF)

First published: 29/11/2019Last updated: 05/07/2022
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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

Senstend : EPAR - Public assessment report

AdoptedReference Number: EMA/625405/2019

English (EN) (848.35 KB - PDF)

First published: Last updated:
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CHMP summary of positive opinion for Senstend

AdoptedReference Number: EMA/CHMP/382383/2019

English (EN) (637.36 KB - PDF)

First published: Last updated:
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More information on Senstend

Public statement on Senstend : Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/581764/2022

English (EN) (113.66 KB - PDF)

First published:
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