Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Targretin   
Auth. number : EU/1/01/178
INN : bexarotene
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX25 - Bexarotene
(See WHO ATC Index)
Indication: For the treatment of skin manifestations of advanced stage CTCL patients refractory to at least one systemic treatment
Marketing Authorisation Holder: Eisai Ltd
3 Shortlands, London W6 8EE, United Kindgdom

  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
02/04/2001 Centralised - Authorisation EMEA/H/C/326 (2001)818 of 29/03/2001
15/07/2002 Centralised - Variation EMEA/H/C/326/I/3 (2002)2733 of 11/07/2002
22/10/2002 Centralised - Variation EMEA/H/C/326/II/2 (2002)4064 of 17/10/2002
06/06/2003 Centralised - Variation EMEA/H/C/326/N/5 (2003)1843 of 04/06/2003
26/03/2004 Centralised - Variation EMEA/H/C/326/IA/6
Updated with Decision(2004)4487 of 17/11/2004
18/06/2004 Centralised - Variation EMEA/H/C/326/N/7
Updated with Decision(2004)4487 of 17/11/2004
10/09/2004 Centralised - Variation EMEA/H/C/326/IA/10
10/09/2004 Centralised - Variation EMEA/H/C/326/IA/9
10/09/2004 Centralised - Variation EMEA/H/C/326/IA/8
04/10/2004 Centralised - Variation EMEA/H/C/326/N/11
Updated with Decision(2006)1746 of 24/04/2006
19/11/2004 Centralised - Variation (2004)4487 of 17/11/2004
08/12/2004 Centralised - Variation EMEA/H/C/326/N/12
Updated with Decision(2006)1746 of 24/04/2006
15/02/2005 Centralised - Variation EMEA/H/C/326/N/13
Updated with Decision(2006)1746 of 24/04/2006
14/11/2005 Centralised - Variation EMEA/H/C/326/N/14
Updated with Decision(2006)1746 of 24/04/2006
26/04/2006 Centralised - Renewal EMEA/H/C/326/R/15 (2006)1746 of 24/04/2006
04/07/2006 Centralised - Variation EMEA/H/C/326/IB/16
Updated with Decision(2007)315 of 26/01/2007
02/08/2006 Centralised - Variation EMEA/H/C/326/IA/17
03/08/2006 Centralised - Variation EMEA/H/C/326/IA/19
13/09/2006 Centralised - Variation EMEA/H/C/326/IA/18
20/12/2006 Centralised - Variation EMEA/H/C/326/IA/21
Updated with Decision(2007)315 of 26/01/2007
21/12/2006 Centralised - Variation EMEA/H/C/326/IB/20
30/01/2007 Centralised - Variation (2007)315 of 26/01/2007
13/04/2007 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/326/T/22 (2007)1693 of 11/04/2007
13/12/2007 Centralised - Variation EMEA/H/C/326/II/23 (2007)6411 of 11/12/2007
20/12/2007 Centralised - Variation EMEA/H/C/326/IA/24
27/08/2008 Centralised - Variation EMEA/H/C/326/II/25 (2008)4672 of 25/08/2008
16/10/2008 Centralised - Variation EMEA/H/C/326/N/26
Updated with Decision(2009)6631 of 21/08/2009
06/02/2009 Centralised - Variation EMEA/H/C/326/IA/27
Updated with Decision(2009)6631 of 21/08/2009
06/04/2009 Centralised - Variation EMEA/H/C/326/IA/28
Updated with Decision(2009)6631 of 21/08/2009
25/08/2009 Centralised - Variation (2009)6631 of 21/08/2009
25/04/2012 Centralised - Variation EMEA/H/C/326/N/31
03/06/2014 Centralised - Variation EMEA/H/C/326/N/39