Senstend

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Withdrawn

This medicine's authorisation has been withdrawn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The European Public Assessment Report (EPAR) for Senstend is updated to indicate that the marketing authorisation is no longer valid.

Senstend : EPAR - Medicine overview

Reference Number: EMA/519240/2019

English (EN) (670.21 KB - PDF)

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italiano (IT) (686.49 KB - PDF)

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magyar (HU) (1.27 MB - PDF)

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Malti (MT) (747.25 KB - PDF)

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Nederlands (NL) (687.46 KB - PDF)

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polski (PL) (744.53 KB - PDF)

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português (PT) (688.19 KB - PDF)

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română (RO) (708.86 KB - PDF)

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slovenčina (SK) (743.36 KB - PDF)

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slovenščina (SL) (701.62 KB - PDF)

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suomi (FI) (1.21 MB - PDF)

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svenska (SV) (666.47 KB - PDF)

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Senstend : EPAR - Risk-management-plan summary

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Product information

Senstend : EPAR - Product information

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български (BG) (1.64 MB - PDF)

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español (ES) (1.66 MB - PDF)

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čeština (CS) (1.37 MB - PDF)

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dansk (DA) (914.89 KB - PDF)

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eesti (ET) (985.34 KB - PDF)

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ελληνικά (EL) (1.71 MB - PDF)

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français (FR) (926.09 KB - PDF)

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hrvatski (HR) (831.74 KB - PDF)

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italiano (IT) (917.55 KB - PDF)

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latviešu (LV) (1.46 MB - PDF)

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lietuvių (LT) (1.01 MB - PDF)

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magyar (HU) (882.02 KB - PDF)

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Malti (MT) (1.42 MB - PDF)

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Nederlands (NL) (917.64 KB - PDF)

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polski (PL) (1.45 MB - PDF)

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português (PT) (993.24 KB - PDF)

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română (RO) (1.02 MB - PDF)

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slovenčina (SK) (1.43 MB - PDF)

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slovenščina (SL) (1.46 MB - PDF)

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suomi (FI) (993.89 KB - PDF)

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svenska (SV) (919.07 KB - PDF)

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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)

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български (BG) (690.65 KB - PDF)

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español (ES) (619.32 KB - PDF)

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čeština (CS) (680 KB - PDF)

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dansk (DA) (619.86 KB - PDF)

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Deutsch (DE) (620.79 KB - PDF)

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eesti (ET) (618 KB - PDF)

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ελληνικά (EL) (687.72 KB - PDF)

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français (FR) (620.68 KB - PDF)

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hrvatski (HR) (662.45 KB - PDF)

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italiano (IT) (619.23 KB - PDF)

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latviešu (LV) (681.09 KB - PDF)

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lietuvių (LT) (663.74 KB - PDF)

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magyar (HU) (678.77 KB - PDF)

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Malti (MT) (681.6 KB - PDF)

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Nederlands (NL) (617.33 KB - PDF)

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polski (PL) (680.16 KB - PDF)

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português (PT) (619.33 KB - PDF)

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română (RO) (663.19 KB - PDF)

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slovenčina (SK) (679.4 KB - PDF)

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slovenščina (SL) (676.69 KB - PDF)

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suomi (FI) (617.2 KB - PDF)

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svenska (SV) (619.13 KB - PDF)

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Íslenska (IS) (826.65 KB - PDF)

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norsk (NO) (619.89 KB - PDF)

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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

Adopted Reference Number: EMA/625405/2019

English (EN) (848.35 KB - PDF)

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CHMP summary of positive opinion for Senstend

Adopted Reference Number: EMA/CHMP/382383/2019

English (EN) (637.36 KB - PDF)

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