Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Ixense
Auth. number : EU/1/01/181
Active substance : apomorphine hydrochloride
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G04 - Urologicals
Pharmacological subgroup: G04B - Other urologicals, including antispasmodics
Chemical subgroup: G04BE - Drugs used in erectile dysfunction
Chemical substance: G04BE07 - apomorphine
(See WHO ATC Index)
Indication: Treatment of erectile dysfunction
Marketing Authorisation Holder: Takeda Europe R&D Centre Ltd
Savanah House, 11/12 Charles II Street, London SW1Y 4QU, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
30/05/2001 Centralised - Authorisation EMEA/H/C/328 (2001)1255 of 28/05/2001
13/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/328/I/2
27/08/2002 Centralised - Variation EMEA/H/C/328/I/3 (2002)3175 of 22/08/2002
04/10/2002 Centralised - Notification EMEA/H/C/328/N/1 (2002)3704 of 02/10/2002
19/05/2003 Centralised - Variation EMEA/H/C/328/II/4 (2003)1679 of 15/05/2003
29/01/2004 Centralised - Variation EMEA/H/C/328/II/5 (2004)211 of 27/01/2004
28/07/2004 Centralised - Variation EMEA/H/C/328/IA/6
Updated with Decision(2004)3388 of 31/08/2004
02/09/2004 Centralised - Variation EMEA/H/C/328 (2004)3388 of 31/08/2004
30/09/2004 Centralised - Withdrawal (2004)3672 of 28/09/2004