Intrinsa

RSS
Withdrawn

This medicine's authorisation has been withdrawn

testosterone
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Intrinsa has been withdrawn at the request of the marketing-authorisation holder.

Intrinsa : EPAR - Summary for the public

English (EN) (282.58 KB - PDF)

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български (BG) (291.39 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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español (ES) (224.65 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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čeština (CS) (266.63 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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dansk (DA) (243.36 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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Deutsch (DE) (225.77 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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eesti keel (ET) (223.17 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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ελληνικά (EL) (298.11 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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français (FR) (225.04 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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italiano (IT) (225.26 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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latviešu valoda (LV) (270.17 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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lietuvių kalba (LT) (250.28 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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magyar (HU) (262.07 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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Malti (MT) (265.74 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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Nederlands (NL) (223.92 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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polski (PL) (263.45 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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português (PT) (224.53 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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română (RO) (249.31 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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slovenčina (SK) (265.91 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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slovenščina (SL) (261.6 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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Suomi (FI) (223.94 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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svenska (SV) (239.94 KB - PDF)

First published: 21/07/2008Last updated: 18/06/2012
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Product information

Intrinsa : EPAR - Product Information

English (EN) (604.23 KB - PDF)

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български (BG) (776.04 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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español (ES) (375.27 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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čeština (CS) (620.46 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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dansk (DA) (521.26 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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Deutsch (DE) (394.85 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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eesti keel (ET) (374.96 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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ελληνικά (EL) (830.64 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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français (FR) (330.76 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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íslenska (IS) (374.24 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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italiano (IT) (324.41 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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latviešu valoda (LV) (703.49 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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lietuvių kalba (LT) (464.98 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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magyar (HU) (613.6 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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Malti (MT) (665.61 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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Nederlands (NL) (381.49 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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norsk (NO) (371.26 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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polski (PL) (585.39 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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português (PT) (324.27 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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română (RO) (477.78 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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slovenčina (SK) (639.84 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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slovenščina (SL) (604.52 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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Suomi (FI) (378.55 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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svenska (SV) (377.35 KB - PDF)

First published: 26/09/2008Last updated: 18/06/2012
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Latest procedure affecting product information: R/0018
25/05/2012
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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).

Intrinsa : EPAR - All Authorised presentations

English (EN) (234.95 KB - PDF)

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български (BG) (172.54 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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español (ES) (115.87 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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čeština (CS) (156.31 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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dansk (DA) (126.77 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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Deutsch (DE) (115.61 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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eesti keel (ET) (115.83 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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ελληνικά (EL) (126.29 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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français (FR) (115.48 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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íslenska (IS) (115.41 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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italiano (IT) (115.35 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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latviešu valoda (LV) (162.57 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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lietuvių kalba (LT) (156.14 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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magyar (HU) (136.21 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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Malti (MT) (168.15 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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Nederlands (NL) (115.96 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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norsk (NO) (116.07 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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polski (PL) (139.9 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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português (PT) (115.29 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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română (RO) (154.68 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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slovenčina (SK) (153.89 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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slovenščina (SL) (139.86 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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Suomi (FI) (115.27 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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svenska (SV) (115.55 KB - PDF)

First published: 05/09/2006Last updated: 18/06/2012
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Product details

Name of medicine
Intrinsa
Active substance
Testosterone
International non-proprietary name (INN) or common name
testosterone
Therapeutic area (MeSH)
Sexual Dysfunctions, Psychological
Anatomical therapeutic chemical (ATC) code
G03BA03

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.

Authorisation details

EMA product number
EMEA/H/C/000634
Marketing authorisation holder
Warner Chilcott UK Ltd.

Old Belfast Road
Milbrook
Larne
County Antrim
BT40 2SH
United Kingdom

Marketing authorisation issued
28/07/2006
Revision
6

Assessment history

Intrinsa : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (181.31 KB - PDF)

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Intrinsa : EPAR - Procedural steps taken before authorisation

English (EN) (138.88 KB - PDF)

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Intrinsa : EPAR - Scientific Discussion

English (EN) (736.34 KB - PDF)

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More information on Intrinsa

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

Reference Number: EMA/360944/2012

English (EN) (61.53 KB - PDF)

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