Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Raptiva
Auth. number : EU/1/04/291
INN : Efalizumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AA - Selective immunosuppressive agents
Chemical substance: L04AA21 - Efalizumab
(See WHO ATC Index)
Indication: Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate and PUVA
Marketing Authorisation Holder: Serono Europe Limited
56, Marsh Wall, London E14 9TP, 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
22/09/2004 Centralised - Authorisation EMEA/H/C/542 (2004)3583 of 20/09/2004
18/11/2004 Centralised - Variation EMEA/H/C/542/N/1
Updated with Decision(2005)3484 of 08/09/2005
06/01/2005 Centralised - Variation EMEA/H/C/542/IB/4
25/01/2005 Centralised - Variation EMEA/H/C/542/II/2
27/01/2005 Centralised - Variation EMEA/H/C/542/II/3
04/08/2005 Centralised - Variation EMEA/H/C/542/II/5
14/09/2005 Centralised - Variation EMEA/H/C/542/II/6 (2005)3484 of 08/09/2005
23/11/2005 Centralised - Variation EMEA/H/C/542/IA/9
05/04/2006 Centralised - Variation EMEA/H/C/542/II/10 (2006)1337 of 29/03/2006
04/05/2006 Centralised - Variation EMEA/H/C/542/II/8
04/05/2006 Centralised - Variation EMEA/H/C/542/II/7
08/06/2006 Centralised - Variation EMEA/H/C/542/II/12
08/06/2006 Centralised - Variation EMEA/H/C/542/II/13
20/06/2006 Corrigendum (2006)1337 corr of 16/06/2006
25/08/2006 Centralised - Variation EMEA/H/C/542/IB/14
Updated with Decision(2007)669 of 23/02/2007
27/02/2007 Centralised - Variation EMEA/H/C/542/II/15, 16 (2007)669 of 23/02/2007
25/09/2007 Centralised - Variation EMEA/H/C/542/II/17
03/12/2007 Centralised - Variation EMEA/H/C/542/II/18 (2007)6025 of 29/11/2007
14/05/2008 Centralised - Variation EMEA/H/C/542/IB/20
Updated with Decision(2008)4743 of 28/08/2008
24/06/2008 Centralised - Variation EMEA/H/C/542/II/19 (2008)3204 of 20/06/2008
03/07/2008 Centralised - Variation EMEA/H/C/542/IB/21
Updated with Decision(2008)4743 of 28/08/2008
01/09/2008 Centralised - Variation EMEA/H/C/542/II/22 (2008)4743 of 28/08/2008
12/09/2008 Centralised - Variation EMEA/H/C/542/IA/25
Updated with Decision(2008)7606 of 25/11/2008
29/10/2008 Centralised - Variation EMEA/H/C/542/II/24
27/11/2008 Centralised - Variation EMEA/H/C/542/II/26 (2008)7606 of 25/11/2008
27/02/2009 Centralised - Variation EMEA/H/C/542/II/27
06/04/2009 Centralised - Variation EMEA/H/C/542/IA/30
21/04/2009 Referral EMEA/H/C/542/A-20/28 (2009)3031 of 17/04/2009
11/06/2009 Centralised - Withdrawal (2009)4604 of 09/06/2009