Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Trisenox   
Auth. number : EU/1/02/204
INN : Arsenic trioxide
Orphan status based on designation EU/3/00/008 added on 07/03/2002
Orphan status based on designation EU/3/00/008 removed or expired on 07/03/2012
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: L01XX27 - Arsenic trioxide
(See WHO ATC Index)
Indication: Induction of remission and consolidation in adult patients with relapsed/refractory acute promyelocytic leukaemia (APL), characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptoralpha (PML/RAR-alpha) gene. Previous treatment should have included a retinoid and chemotherapy.
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, 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
07/03/2002 Centralised - Authorisation EMEA/H/C/388 (2002)980 of 05/03/2002
22/05/2002 Centralised - Variation EMEA/H/C/388/I/1 (2002)1965 of 17/05/2002
23/09/2002 Centralised - Variation EMEA/H/C/388/I/2
10/10/2003 Centralised - Annual reassessment EMEA/H/C/388/S/3 (2003)3734 of 08/10/2003
07/01/2004 Centralised - Variation EMEA/H/C/388/IA/4
Updated with Decision(2004)3478 of 09/09/2004
04/02/2004 Centralised - Variation EMEA/H/C/388/IB/5
Updated with Decision(2004)3478 of 09/09/2004
24/02/2004 Centralised - Variation EMEA/H/C/388/IA/6
Updated with Decision(2004)3478 of 09/09/2004
09/03/2004 Centralised - Variation EMEA/H/C/388/IA/11
09/03/2004 Centralised - Variation EMEA/H/C/388/IA/7
10/03/2004 Centralised - Variation EMEA/H/C/388/IA/10
10/03/2004 Centralised - Variation EMEA/H/C/388/IA/9
25/03/2004 Centralised - Variation EMEA/H/C/388/IB/8
13/09/2004 Centralised - Annual reassessment EMEA/H/C/388/S/13 (2004)3478 of 09/09/2004
23/11/2004 Centralised - Variation EMEA/H/C/388/II/12
06/07/2005 Centralised - Variation EMEA/H/C/388/II/14 (2005)2569 of 04/07/2005
10/10/2005 Centralised - Annual reassessment EMEA/H/C/388/S/15 (2005)3868 of 06/10/2005
27/04/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/388/T/16 (2006)1757 of 24/04/2006
09/06/2006 Centralised - Variation EMEA/H/C/388/IA/18
09/06/2006 Centralised - Variation EMEA/H/C/388/IA/20
12/06/2006 Centralised - Variation EMEA/H/C/388/IA/19
13/07/2006 Centralised - Annual reassessment EMEA/H/C/388/S/17 (2006)3252 of 11/07/2006
18/01/2007 Centralised - Variation EMEA/H/C/388/IA/22
Updated with Decision(2007)2492 of 05/06/2007
15/02/2007 Centralised - Variation EMEA/H/C/388/IA/24
18/02/2007 Centralised - Variation EMEA/H/C/388/IA/23
19/02/2007 Centralised - Renewal EMEA/H/C/388/R/21 (2007)542 of 15/02/2007
03/05/2007 Centralised - Variation EMEA/H/C/388/II/25
08/06/2007 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/388/T/27 (2007)2492 of 05/06/2007
25/07/2007 Centralised - Annual reassessment EMEA/H/C/388/S/26 (2007)3629 of 23/07/2007
10/03/2008 Centralised - Variation EMEA/H/C/388/IA/28
09/04/2008 Centralised - Variation EMEA/H/C/388/IA/30
29/07/2008 Centralised - Annual reassessment EMEA/H/C/388/S/29 (2008)4106 of 25/07/2008
23/04/2009 Centralised - Variation EMEA/H/C/388/II/31 (2009)3137 of 21/04/2009
23/06/2009 Centralised - Variation EMEA/H/C/388/IA/34
24/06/2009 Centralised - Variation EMEA/H/C/388/IA/35
23/09/2009 Centralised - Annual reassessment EMEA/H/C/388/S/33 (2009)7423 of 21/09/2009
19/05/2010 Centralised - Variation EMEA/H/C/388/IB/37
Updated with Decision(2010)5681 of 10/08/2010
12/08/2010 Centralised - Annual reassessment EMEA/H/C/388/S/36 (2010)5681 of 10/08/2010
08/12/2010 Centralised - Variation EMEA/H/C/388/IB/39
08/12/2010 Centralised - Variation EMEA/H/C/388/IB/39
08/12/2010 Centralised - Variation EMEA/H/C/388/IA/40
24/11/2011 Centralised - Variation EMEA/H/C/388/II/41 (2011)8686 of 22/11/2011
07/03/2012 Centralised - (orphan status)
02/07/2012 Centralised - Variation EMEA/H/C/388/II/42 (2012)4501 of 27/06/2012
30/01/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/388/T/44 (2013)528 of 28/01/2013
22/10/2013 Centralised - Variation EMEA/H/C/38/N/47
19/11/2013 Centralised - Variation EMEA/H/C/388/IAIN/48
29/01/2014 Centralised - Variation EMEA/H/C/38/N/49
13/05/2014 Centralised - Variation EMEA/H/C/38/IB/50