Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Temodal   
Auth. number : EU/1/98/096
INN : temozolomide
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01A - Alkylating agents
Chemical subgroup: L01AX - Other alkylating agents
Chemical substance: L01AX03 - Temozolomide
(See WHO ATC Index)
Indication: Treatment of:- adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.- children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Marketing Authorisation Holder: Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, 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
28/01/1999 Centralised - Authorisation EMEA/H/C/229 (1999)49 of 26/01/1999
25/08/1999 Centralised - Variation EMEA/H/C/229/II/2 (1999)2748 of 18/08/1999
27/07/2000 Centralised - Variation EMEA/H/C/229/I/3
20/04/2001 Centralised - Variation EMEA/H/C/229/I/5
23/05/2001 Centralised - Variation EMEA/H/C/229/I/6
12/04/2002 Centralised - Variation EMEA/H/C/229/II/4
15/04/2002 Centralised - Variation EMEA/H/C/229/II/7 (2002)1456 of 11/04/2002
04/09/2002 Centralised - Variation EMEA/H/C/229/I/8
22/01/2003 Centralised - Variation EMEA/H/C/229/I/10
10/03/2003 Centralised - Variation EMEA/H/C/229/II/9 (2003)774 of 06/03/2003
21/08/2003 Centralised - Variation EMEA/H/C/229/I/11
23/01/2004 Centralised - Variation EMEA/H/C/229/IA/18
23/01/2004 Centralised - Variation EMEA/H/C/229/IA/16
23/01/2004 Centralised - Variation EMEA/H/C/229/IA/17
09/02/2004 Centralised - Variation EMEA/H/C/229/II/14 (2004)406 of 05/02/2004
12/03/2004 Centralised - Renewal EMEA/H/C/229/R/13 (2004)854 of 10/03/2004
19/05/2004 Centralised - Variation EMEA/H/C/229/N/19
Updated with Decision(2005)1742 of 03/06/2005
06/09/2004 Centralised - Variation EMEA/H/C/229/IB/20
07/06/2005 Centralised - Variation EMEA/H/C/229/II/21 (2005)1742 of 03/06/2005
12/08/2005 Centralised - Variation EMEA/H/C/229/IA/22
12/08/2005 Centralised - Variation EMEA/H/C/229/IA/23
18/11/2005 Centralised - Variation EMEA/H/C/229/II/24 (2005)4505 of 15/11/2005
16/05/2006 Centralised - Variation EMEA/H/C/229/IA/25
Updated with Decision(2007)36 of 04/01/2007
16/05/2006 Centralised - Variation EMEA/H/C/229/IA/27
27/05/2006 Centralised - Variation EMEA/H/C/229/IA/28
12/06/2006 Centralised - Variation EMEA/H/C/229/IB/26
Updated with Decision(2007)36 of 04/01/2007
13/06/2006 Centralised - Variation EMEA/H/C/229/IA/29
09/01/2007 Centralised - Variation EMEA/H/C/229/II/31 (2007)36 of 04/01/2007
25/04/2007 Centralised - Variation EMEA/H/C/229/X/30 (2007)1883 of 23/04/2007
07/05/2007 Centralised - Variation EMEA/H/C/229/IA/33
30/07/2007 Centralised - Variation EMEA/H/C/229/II/32 (2007)3706 of 25/07/2007
12/09/2007 Centralised - Variation EMEA/H/C/229/IA/34
19/03/2008 Centralised - Variation EMEA/H/C/229/IA/37
12/06/2008 Centralised - Variation EMEA/H/C/229/IB/38
Updated with Decision(2009)489 of 22/01/2009
27/06/2008 Centralised - Variation EMEA/H/C/229/II/36 (2008)3288 of 25/06/2008
27/11/2008 Centralised - Variation EMEA/H/C/229/II/41 (2008)7603 of 25/11/2008
22/12/2008 Centralised - Renewal EMEA/H/C/229/R/40 (2008)8811 of 17/12/2008
27/01/2009 Centralised - Variation EMEA/H/C/229/II/39 (2009)489 of 22/01/2009
19/02/2009 Centralised - Variation EMEA/H/C/229/X/35 (2009)1179 of 17/02/2009
05/03/2009 Centralised - Variation EMEA/H/C/229/IB/42
09/07/2009 Centralised - Variation EMEA/H/C/229/IB/44
Updated with Decision(2010)830 of 03/02/2010
02/10/2009 Centralised - Variation EMEA/H/C/229/IB/46
26/10/2009 Centralised - Variation EMEA/H/C/229/N/47
Updated with Decision(2010)830 of 03/02/2010
12/11/2009 Centralised - Variation EMEA/H/C/229/IB/48
05/02/2010 Centralised - Variation (2010)830 of 03/02/2010
11/02/2010 Centralised - Variation EMEA/H/C/229/II/45 (2010)923 of 09/02/2010
08/07/2010 Centralised - Variation EMEA/H/C/229/IB/49
Updated with Decision(2011)883 of 08/02/2011
03/11/2010 Centralised - Variation EMEA/H/C/229/N/50
Updated with Decision(2011)883 of 08/02/2011
15/12/2010 Centralised - Variation EMEA/H/C/229/IA/51/G
14/02/2011 Centralised - Variation (2011)883 of 08/02/2011
27/05/2011 Centralised - Variation EMEA/H/C/229/IB/53/G
Updated with Decision(2012)194 of 13/01/2012
16/06/2011 Centralised - Variation EMEA/H/C/229/II/52 (2011)4290 of 14/06/2011
05/08/2011 Centralised - Variation EMEA/H/C/229/N/54
Updated with Decision(2012)194 of 13/01/2012
16/09/2011 Centralised - Variation EMEA/H/C/229/N/56
Updated with Decision(2012)194 of 13/01/2012
16/11/2011 Centralised - Variation EMEA/H/C/229/IA/57
Updated with Decision(2012)194 of 13/01/2012
18/01/2012 Centralised - Variation (2012)194 of 13/01/2012
02/02/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/229/T/58 (2012)653 of 31/01/2012
02/07/2012 Centralised - Variation EMEA/H/C/229/II/59 (2012)4503 of 27/06/2012
28/11/2012 Referral EMEA/H/C/229/A-20/60 (2012)8834 of 26/11/2012
13/12/2012 Centralised - Variation EMEA/H/C/229/II/62
Updated with Decision(2013)9749 of 18/12/2013
22/07/2013 Centralised - Variation EMEA/H/C/229/N/64
Updated with Decision(2013)9749 of 18/12/2013
23/12/2013 Centralised - Variation EMEA/H/C/229/II/63 (2013)9749 of 18/12/2013
22/05/2014 Centralised - Variation EMEA/H/C/229/II/68