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Community Register of medicinal products
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: | L - Antineoplastic and immunomodulating agents L01 - Cytostatics L01X - Other cytostatics L01XX - Other antineoplastic agents L01XX27 - Arsenic trioxide (See WHO ATC Index) |
| Indication: | Trisenox is indicated for 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| 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/7 | ||||
| 09/03/2004 | Centralised - Variation | EMEA/H/C/388/IA/11 | ||||
| 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/20 | ||||
| 09/06/2006 | Centralised - Variation | EMEA/H/C/388/IA/18 | ||||
| 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 | ||||||
| 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 |