Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Foscan   
Auth. number : EU/1/01/197
Active substance : temoporfin
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XD - Sensitizers used in photodynamic/radiation therapy
Chemical substance: L01XD05 - Temoporfin
(See WHO ATC Index)
Indication: Palliative treatment of patients with head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy
Marketing Authorisation Holder: biolitec pharma ltd.
Unit 9A, Plato Business Park, Damastown, Dublin 15, Ireland.
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
25/10/2001 Centralised - Authorisation EMEA/H/C/318 (2001)2897 of 24/10/2001
21/02/2002 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/318/T/1 (2002)656 of 19/02/2002
08/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/318/I/3
16/04/2002 Centralised - Variation EMEA/H/C/318/I/2 (2002)1493 of 12/04/2002
19/09/2002 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/318/T/4 (2002)3429 of 13/09/2002
12/11/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/318/I/6
09/12/2002 Centralised - Variation EMEA/H/C/318/I/5 (2002)5019 of 05/12/2002
15/07/2003 Centralised - Annual reassessment EMEA/H/C/318/S/7 (2003)2564 of 09/07/2003
20/08/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/318/I/8
22/10/2003 Centralised - Variation EMEA/H/C/318/I/9 (2003)3967 of 20/10/2003
24/02/2004 Centralised - Annual reassessment EMEA/H/C/318/S/10 (2004)613 of 20/02/2004
07/01/2005 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/318/T/11 (2005)19 of 05/01/2005
14/03/2005 Centralised - Variation EMEA/H/C/318/IB/13
Updated with Decision(2005)4089 of 13/10/2005
01/04/2005 Centralised - Annual reassessment EMEA/H/C/318/S/12 (2005)1080 of 29/03/2005
10/08/2005 Centralised - Variation EMEA/H/C/318/IA/14
Updated with Decision(2005)4089 of 13/10/2005
06/09/2005 Centralised - Variation EMEA/H/C/318/IA/15
Updated with Decision(2005)4089 of 13/10/2005
29/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/318/IA/16
18/10/2005 Centralised - Variation (2005)4089 of 13/10/2005
28/06/2006 Centralised - Annual reassessment EMEA/H/C/318/S/17
01/12/2006 Centralised - Renewal EMEA/H/C/318/R/18 (2006)5929 of 29/11/2006
18/04/2007 Centralised - Annual reassessment EMEA/H/C/318/S/20 (2007)1768 of 13/04/2007
25/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/318/IA/21
18/10/2007 Centralised - Variation EMEA/H/C/318/X/19 (2007)5148 of 15/10/2007
23/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/318/II/22
23/05/2008 Centralised - Annual reassessment EMEA/H/C/318/S/23 (2008)2182 of 21/05/2008
23/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/318/IA/24
21/04/2009 Centralised - Variation EMEA/H/C/318/IB/25
Updated with Decision(2009)8719 of 05/11/2009
09/11/2009 Centralised - Variation (2009)8719 of 05/11/2009
12/09/2011 Centralised - Variation EMEA/H/C/318/IB/29
Updated with Decision(2012)2551 of 13/04/2012
17/04/2012 Centralised - Variation (2012)2551 of 13/04/2012
21/09/2012 Centralised - Variation EMEA/H/C/318/IB/31
Updated with Decision(2012)7887 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7887 of 29/10/2012
29/05/2013 Centralised - Notification EMEA/H/C/318/N/33
Updated with Decision(2013)6863 of 11/10/2013
14/10/2013 PSUSA - Modification EMEA/H/C/318/PSU/26 (2013)6863 of 11/10/2013
05/06/2014 Centralised - Variation EMEA/H/C/318/IA/34
Updated with Decision(2015)4868 of 08/07/2015
24/07/2014 Centralised - Variation EMEA/H/C/318/IA/35
Updated with Decision(2015)4868 of 08/07/2015