Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Temozolomide SUN   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Temozolomid SUN (SL)
Auth. number : EU/1/11/697
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: Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, NL-2132 JH Hoofddorp, 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 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
18/07/2011 Centralised - Authorisation EMEA/H/C/2198 (2011)5207 of 13/07/2011
05/09/2012 Centralised - Variation EMEA/H/C/2198/IB/1
Updated with Decision(2012)7732 of 25/10/2012
03/10/2012 Centralised - Variation EMEA/H/C/2198/IB/2/G
Updated with Decision(2012)7732 of 25/10/2012
30/10/2012 Centralised - Variation (2012)7732 of 25/10/2012
20/03/2013 Centralised - Variation EMEA/H/C/2198/IB/4
Updated with Decision(2014)2059 of 21/03/2014
06/02/2014 Centralised - Variation EMEA/H/C/2198/IB/7
Updated with Decision(2014)2059 of 21/03/2014
06/02/2014 Centralised - Variation EMEA/H/C/2198/IB/9
Updated with Decision(2014)2059 of 21/03/2014
12/02/2014 Centralised - Variation EMEA/H/C/2198/IAin/8
Updated with Decision(2014)2059 of 21/03/2014
25/03/2014 Centralised - Yearly update (2014)2059 of 21/03/2014
16/07/2014 Centralised - Variation EMEA/H/C/2198/IB/12
14/08/2014 Centralised - Variation EMEA/H/C/2198/IB/13