Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Panretin   
Auth. number : EU/1/00/149
INN : alitretinoin
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: L01XX22 - Alitretinoin
(See WHO ATC Index)
Indication: Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with AIDS-related
Kaposi’s sarcoma (KS) when:
- lesions are not ulcerated or lymphoedematous, and
- treatment of visceral KS is not required, and
- lesions are not responding to systemic antiretroviral therapy, and
- radiotherapy or chemotherapy are not appropriate
Marketing Authorisation Holder: Eisai Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, 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
19/10/2000 Centralised - Authorisation EMEA/H/C/279 (2000)2808 of 11/10/2000
15/07/2002 Centralised - Variation EMEA/H/C/279/I/2 (2002)2706 of 10/07/2002
07/02/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/279/I/4, 5, 6
15/04/2003 Centralised - Notification EMEA/H/C/279/N/7 (2003)1270 of 10/04/2003
13/06/2003 Centralised - Notification EMEA/H/C/279/N/8 (2003)1898 of 11/06/2003
26/03/2004 Centralised - Variation EMEA/H/C/279/IA/9
Updated with Decision(2004)4850 of 06/12/2004
08/12/2004 Centralised - Variation (2004)4850 of 06/12/2004
24/05/2005 Centralised - Notification EMEA/H/C/279/N/11
Updated with Decision(2005)4539 of 17/11/2005
21/11/2005 Centralised - Renewal EMEA/H/C/279/R/12 (2005)4539 of 17/11/2005
20/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/279/IA/13
24/01/2006 Centralised - Notification EMEA/H/C/279/N/14
Updated with Decision(2007)1692 of 11/04/2007
11/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/279/IB/15
19/01/2007 Centralised - Variation EMEA/H/C/279/IA/16
Updated with Decision(2007)1692 of 11/04/2007
13/04/2007 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/279/T/17 (2007)1692 of 11/04/2007
16/10/2008 Centralised - Notification EMEA/H/C/279/N/18
Updated with Decision(2009)6728 of 28/08/2009
06/02/2009 Centralised - Variation EMEA/H/C/279/IA/19
Updated with Decision(2009)6728 of 28/08/2009
27/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/279/IB/20
06/04/2009 Centralised - Variation EMEA/H/C/279/IA/21
Updated with Decision(2009)6728 of 28/08/2009
01/09/2009 Centralised - Variation (2009)6728 of 28/08/2009
06/01/2010 Centralised - Variation EMEA/H/C/279/IA/22
Updated with Decision(2010)2168 of 26/03/2010
30/03/2010 Centralised - Variation (2010)2168 of 26/03/2010
11/05/2010 Centralised - Notification EMEA/H/C/279/N/23
Updated with Decision(2010)6781 of 27/09/2010
29/09/2010 Centralised - Renewal EMEA/H/C/279/R/24 (2010)6781 of 27/09/2010
25/01/2012 Centralised - Variation EMEA/H/C/279/IA/26
Updated with Decision(2012)6021 of 23/08/2012
07/08/2012 Centralised - Notification EMEA/H/C/279/N/27
Updated with Decision(2014)6035 of 19/08/2014
28/08/2012 Centralised - Variation (2012)6021 of 23/08/2012
08/07/2013 Centralised - Notification EMEA/H/C/279/N/28
Updated with Decision(2014)6035 of 19/08/2014
07/10/2013 Centralised - Variation EMEA/H/C/279/IB/31
Updated with Decision(2014)6035 of 19/08/2014
21/08/2014 Centralised - Yearly update (2014)6035 of 19/08/2014