Ixense

Withdrawn

This medicine's authorisation has been withdrawn

apomorphine

Overview

On 28 May 2001 the European Commission granted a marketing authorisation for the whole European Union to Takeda Europe R&D Centre Ltd, for Ixense (apomorphine hydrochloride), indicated for the treatment of erectile dysfunction. Ixense has been marketed in Austria, Germany, France and Italy. On 23 August 2004 the Marketing Authorisation Holder notified the European Commission of its decision to voluntarily withdraw the Marketing Authorisation for Ixense for commercial reasons. 

There is still one Community Marketing Authorisation valid throughout the European Union for medicinal products containing apomorphine hydrochloride i.e. Uprima. On 28 September 2004 the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use Ixense. 

Pursuant to this decision the European Public Assessment Report for Ixense has been removed from this website.

Product information

Product details

• Name of medicine:
  Ixense
• Active substance:
  apomorphine hydrochloride
• International non-proprietary name (INN) or common name:
  apomorphine
• Therapeutic area (MeSH):
  Erectile Dysfunction
• Anatomical therapeutic chemical (ATC) code:
  G04BE

Pharmacotherapeutic group

Urologicals

Therapeutic indication

Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
In order for Ixense to be effective, sexual stimulation is required.

Authorisation details

• EMA product number:
  EMEA/H/C/000328
• Marketing authorisation holder:
  Takeda Europe R Centre Ltd.

  Takeda Global Research and Development Centre (Europe) Ltd.; Arundel Great Court; 2 Arundel Street; London WC2R 3DA; United Kingdom

• Marketing authorisation issued:
  28/05/2001
• Withdrawal of marketing authorisation:
  28/09/2004