Intrinsa

RSS

testosterone

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Intrinsa has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 18/06/2012

Authorisation details

Product details
Name
Intrinsa
Agency product number
EMEA/H/C/000634
Active substance
Testosterone
International non-proprietary name (INN) or common name
testosterone
Therapeutic area (MeSH)
Sexual Dysfunctions, Psychological
Anatomical therapeutic chemical (ATC) code
G03BA03
Publication details
Marketing-authorisation holder
Warner Chilcott UK Ltd.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
28/07/2006
Contact address
Old Belfast Road
Milbrook
Larne
County Antrim
BT40 2SH
United Kingdom

Product information

25/05/2012 Intrinsa - EMEA/H/C/000634 - R/0018

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

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.

Assessment history

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