Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Zenapax
Auth. number : EU/1/99/098
INN : daclizumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AC - Interleukin inhibitors
Chemical substance: L04AC01 - Daclizumab
(See WHO ATC Index)
Indication: Prophylaxis of acute organ rejection in de novo allogenic renal transplantation
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, 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
05/03/1999 Centralised - Authorisation EMEA/H/C/198 (1999)453 of 26/02/1999
04/09/2000 Centralised - Variation EMEA/H/C/198/II/3 (2000)2538 of 28/08/2000
13/09/2000 Centralised - Variation EMEA/H/C/198/I/4 (2000)2562 of 12/09/2000
02/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/198/I/5
12/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/198/I/6
20/02/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/198/II/7
26/06/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/198/II/8
30/08/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/198/I/9
28/05/2002 Centralised - Variation EMEA/H/C/198/II/11 (2002)2027 of 24/05/2002
11/09/2002 Centralised - Notification EMEA/H/C/198/N/12 (2002)3369 of 09/09/2002
23/04/2003 Centralised - Notification EMEA/H/C/198/N/14 (2003)1377 of 16/04/2003
22/10/2003 Centralised - Variation EMEA/H/C/198/II/15, 16 (2003)3956 of 20/10/2003
23/12/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/198/II/17
16/04/2004 Centralised - Renewal EMEA/H/C/198/R/18 (2004)1463 of 14/04/2004
05/07/2004 Centralised - Notification EMEA/H/C/198/N/19
Updated with Decision(2006)3023 of 26/06/2006
08/11/2005 Centralised - Variation EMEA/H/C/198/IB/21
Updated with Decision(2006)3023 of 26/06/2006
12/01/2006 Centralised - Variation EMEA/H/C/198/IA/22
Updated with Decision(2006)3023 of 26/06/2006
01/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/198/II/20
31/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/198/IA/25
28/06/2006 Centralised - Variation (2006)3023 of 26/06/2006
09/08/2006 Centralised - Variation EMEA/H/C/198/II/24 (2006)3666 of 07/08/2006
27/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/198/II/23
26/01/2007 Centralised - Variation EMEA/H/C/198/IA/26
Updated with Decision(2007)5214 of 18/10/2007
23/10/2007 Centralised - Variation (2007)5214 of 18/10/2007
12/06/2008 Centralised - Withdrawal (2008)2745 of 10/06/2008