Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Temozolomide Sandoz   

   This product is authorised under a different brandname in the EU in the folowing languages:
   - Temozolomid Sandoz (DE)
Auth. number : EU/1/10/617
Active substance : 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: Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich
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
17/03/2010 Centralised - Authorisation EMEA/H/C/1128 (2010)1798 of 15/03/2010
22/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1128/IA/1
06/07/2010 Centralised - Notification EMEA/H/C/1128/N/2
Updated with Decision(2011)4620 of 23/06/2011
05/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1128/IB/4G
27/06/2011 Centralised - Variation EMEA/H/C/1128/II/5/G (2011)4620 of 23/06/2011
04/01/2012 Centralised - Variation EMEA/H/C/1128/IB/8
Updated with Decision(2012)4212 of 15/06/2012
04/01/2012 Centralised - Variation EMEA/H/C/1128/IB/9
Updated with Decision(2012)4212 of 15/06/2012
19/04/2012 Centralised - Variation EMEA/H/C/1128/IB/11/G
Updated with Decision(2012)4212 of 15/06/2012
15/06/2012 Centralised - Variation EMEA/H/C/1128/IB/12
Updated with Decision(2012)7757 of 25/10/2012
20/06/2012 Centralised - Variation (2012)4212 of 15/06/2012
05/09/2012 Centralised - Variation EMEA/H/C/1128/IB/14
Updated with Decision(2012)7757 of 25/10/2012
12/11/2012 Centralised - Variation (2012)7757 of 25/10/2012
19/12/2012 Centralised - Variation EMEA/H/C/1128/IB/15
Updated with Decision(2014)420 of 22/01/2014
10/04/2013 Centralised - Variation EMEA/H/C/1128/IB/17
Updated with Decision(2014)420 of 22/01/2014
24/01/2014 Centralised - Yearly update (2014)420 of 22/01/2014
12/02/2014 Centralised - Variation EMEA/H/C/1128/IB/18
Updated with Decision(2014)8896 of 19/11/2014
19/08/2014 Centralised - Variation EMEA/H/C/1128/IB/21
Updated with Decision(2014)8896 of 19/11/2014
21/11/2014 Centralised - Renewal EMEA/H/C/1128/R/20 (2014)8896 of 19/11/2014
18/03/2015 Centralised - Transfer Marketing Authorisation Holder (2015)1914 of 16/03/2015