Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Hycamtin   
Auth. number : EU/1/96/027
INN : Topotecan hydrochloride
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: L01XX17 - Topotecan
(See WHO ATC Index)
Indication: Topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.- patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriateTopotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Marketing Authorisation Holder: SmithKline Beecham Ltd
980 Great West Road, Brentford, Middlesex TW8 9GS, 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
13/11/1996 Centralised - Authorisation EMEA/H/C/123 (96)3243 of 12/11/1996
17/04/1997 Centralised - Variation EMEA/H/C/123/II/1 (97)1081 of 15/04/1997
29/01/1999 Centralised - Variation EMEA/H/C/123/I/4 (1999)175 of 27/01/1999
08/04/1999 Centralised - Variation (rejected) EMEA/H/C/123/II/3 (1999)840 of 29/03/1999
10/05/1999 Centralised - Variation EMEA/H/C/123/II/6 (1999)1037 of 26/04/1999
09/07/1999 Centralised - Notification EMEA/H/C/123/N/7 (1999)1849 of 01/07/1999
09/02/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/I/13
02/03/2000 Centralised - Variation EMEA/H/C/123/I/11 - EMEA/H/C/123/N/12 (2000)437 of 22/02/2000
20/03/2000 Centralised - Authorisation EMEA/H/C/123/II/10 (2000)605 of 16/03/2000
22/03/2000 Centralised - Variation EMEA/H/C/123/II/10 (2000)722 of 16/03/2000
19/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/I/14
26/09/2000 Centralised - Notification EMEA/H/C/235/N/15, 16 (2000)2601 of 25/09/2000
21/03/2001 Centralised - Variation EMEA/H/C/123/II/17 (2001)614 of 20/03/2001
05/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/I/20
05/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/I/19
14/09/2001 Centralised - Variation EMEA/H/C/123/II/18 (2001)2198 of 13/09/2001
06/02/2002 Centralised - Renewal EMEA/H/C/123/R/21 (2002)466 of 04/02/2002
22/07/2002 Centralised - Variation (2002)2386 of 18/07/2002
01/08/2002 Centralised - Variation EMEA/H/C/123/II/22 (2002)3020 of 30/07/2002
13/12/2002 Centralised - Notification EMEA/H/C/123/N/25 (2002)5197 of 11/12/2002
10/02/2003 Centralised - Notification EMEA/H/C/123/N/27 (2003)506 of 06/02/2003
17/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/I/29
23/07/2003 Centralised - Notification EMEA/H/C/123/N/32 (2003)2715 of 18/07/2003
28/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/II/30
26/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/II/31
16/06/2004 Centralised - Notification EMEA/H/C/123/N/33
Updated with Decision(2006)76 of 13/01/2006
29/06/2005 Centralised - Variation EMEA/H/C/123/IA/35
Updated with Decision(2006)76 of 13/01/2006
30/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/IA/36
14/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/IA/37
17/01/2006 Centralised - Variation EMEA/H/C/123/II/34 (2006)76 of 13/01/2006
22/11/2006 Centralised - Renewal EMEA/H/C/123/R/39 (2006)5666 of 20/11/2006
24/11/2006 Centralised - Variation EMEA/H/C/123/II/38, 40 (2006)5731 of 22/11/2006
02/03/2007 Centralised - Variation EMEA/H/C/123/II/41 (2007)744 of 28/02/2007
25/06/2007 Centralised - Variation EMEA/H/C/123/II/42 (2007)3135 of 21/06/2007
10/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/IA/45
26/10/2007 Centralised - Variation EMEA/H/C/123/II/46 (2007)5305 of 24/10/2007
20/03/2008 Centralised - Variation EMEA/H/C/123/X/44 (2008)1178 of 18/03/2008
07/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/IA/48
21/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/IA/49
04/09/2008 Centralised - Variation EMEA/H/C/123/IA/50
Updated with Decision(2008)6609 of 30/10/2008
04/11/2008 Centralised - Variation EMEA/H/C/123/II/47 (2008)6609 of 30/10/2008
18/12/2008 Centralised - Variation EMEA/H/C/123/IA/51
Updated with Decision(2009)2067 of 17/03/2009
19/03/2009 Centralised - Variation EMEA/H/C/123/II/52 (2009)2067 of 17/03/2009
04/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/IA/53
16/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/IB/54
04/01/2010 Centralised - Variation EMEA/H/C/123/IA/56
Updated with Decision(2010)405 of 20/01/2010
22/01/2010 Centralised - Variation EMEA/H/C/123/II/55 (2010)405 of 20/01/2010
10/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/123/IB/57
04/11/2010 Centralised - Variation EMEA/H/C/123/II/59 (2010)7623 of 28/10/2010
19/01/2011 Centralised - Variation EMEA/H/C/123/IG/34/G
Updated with Decision(2011)5831 of 05/08/2011
10/08/2011 Centralised - Variation (2011)5831 of 05/08/2011
13/02/2013 Centralised - Notification EMEA/H/C/123/N/62
Updated with Decision(2013)8346 of 20/11/2013
22/11/2013 Centralised - 2-Monthly update EMEA/H/C/123/II/64 (2013)8346 of 20/11/2013