Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: PhotoBarr
Auth. number : EU/1/04/272
Active substance : Porfimer sodium
Orphan market exclusivity for "Treatment of high-grade dysplasia in Barrett’s Esophagus" (based on designation EU/3/02/086) started on 29/03/2004
   10 years of market exclusivity
   This orphan market exclusivity has ended on 25/04/2012
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: L01XD01 - Porfimer sodium
(See WHO ATC Index)
Indication: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO)
Marketing Authorisation Holder: Pinnacle Biologics B.V.
p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, NL-1043 DP Amsterdam, Nederland
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
29/03/2004 Centralised - Authorisation EMEA/H/C/493 (2004)1205 of 25/03/2004
07/05/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/493/IA/1
03/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/493/IA/4
11/11/2004 Centralised - Notification EMEA/H/C/493/N/3
18/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/493/II/7
28/12/2005 Centralised - Variation EMEA/H/C/493/II/8 (2005)6006 of 23/12/2005
28/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/493/IA/11
25/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/493/II/10
25/10/2006 Centralised - Variation EMEA/H/C/493/I/12I (2006)5155 of 23/10/2006
16/04/2007 Centralised - Variation EMEA/H/C/493/IB/13
Updated with Decision(2007)5512 of 08/11/2007
14/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/493/IB/15
19/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/493/IB/16
06/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/493/IB/18
26/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/493/II/17
12/11/2007 Centralised - Variation (2007)5512 of 08/11/2007
10/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/493/IA/19
15/12/2008 Centralised - Variation EMEA/H/C/493/IA/21
Updated with Decision(2009)1650 of 04/03/2009
05/03/2009 Centralised - Variation - Decision addressed to Member States EMEA/H/C/493/R/20 (2009)1651 of 04/03/2009
06/03/2009 Centralised - Renewal EMEA/H/C/493/R/20 (2009)1650 of 04/03/2009
28/05/2010 Centralised - Variation EMEA/H/C/493/IA/24
Updated with Decision(2011)65 of 06/01/2011
04/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/493/IA/25/G
28/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/493/II/26
10/01/2011 Centralised - Variation EMEA/H/C/493/II/23 (2011)65 of 06/01/2011
02/08/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/493/T/27 (2011)5611 of 27/07/2011
25/04/2012 Centralised - Withdrawal (2012)2843 of 20/04/2012