Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Temozolomide Teva   
Auth. number : EU/1/09/606
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: Adult patients with newly-diagnosed glioblastoma multiforme. Children from the age of three years, adolescents and adult patients with malignant glioma.
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 continues to be 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
01/02/2010 Centralised - Authorisation EMEA/H/C/1126 (2010)664 of 28/01/2010
05/05/2010 Centralised - Variation EMEA/H/C/1126/IA/1/G
Updated with Decision(2010)8564 of 26/11/2010
13/07/2010 Centralised - Variation EMEA/H/C/1126/IB/2/G
30/11/2010 Centralised - Variation EMEA/H/C/1126/IB/3
01/12/2010 Centralised - Variation (2010)8564 of 26/11/2010
19/01/2011 Centralised - Variation EMEA/H/C/1126/IA/4
Updated with Decision(2011)2419 of 31/03/2011
04/04/2011 Centralised - Variation (2011)2419 of 31/03/2011
07/06/2011 Centralised - Variation EMEA/H/C/1126/N/5
Updated with Decision(2012)3715 of 31/05/2012
07/11/2011 Centralised - Variation EMEA/H/C/1126/IB/6
Updated with Decision(2012)3715 of 31/05/2012
27/01/2012 Centralised - Variation EMEA/H/C/1126/IB/8/G
Updated with Decision(2012)3715 of 31/05/2012
04/06/2012 Centralised - Variation (2012)3715 of 31/05/2012
13/06/2012 Centralised - Variation EMEA/H/C/1126/IAin/10
Updated with Decision(2012)7730 of 25/10/2012
10/10/2012 Centralised - Variation EMEA/H/C/1126/IB/11
Updated with Decision(2012)7730 of 25/10/2012
29/10/2012 Centralised - Variation (2012)7730 of 25/10/2012
07/02/2013 Centralised - Variation EMEA/H/C/1126/IAin/14
Updated with Decision(2014)1001 of 11/02/2014
10/04/2013 Centralised - Variation EMEA/H/C/1126/IB/15
Updated with Decision(2014)1001 of 11/02/2014
23/01/2014 Centralised - Variation EMEA/H/C/1126/IB/18
Updated with Decision(2014)1001 of 11/02/2014
14/02/2014 Centralised - Variation (2014)1001 of 11/02/2014