Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Temozolomide HEXAL   

   This product is authorised under a different brandname in the EU in the folowing languages:
   - Temozolomida (ES)
   - Temozolomida (RO)
   - Temozolomid (SL)
Auth. number : EU/1/10/616
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: Ttreatment 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: Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, Deutschland
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/1127 (2010)1797 of 15/03/2010
22/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1127/IA/1
05/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1127/IB/3/G
27/06/2011 Centralised - Variation EMEA/H/C/1127/II/4/G (2011)4619 of 23/06/2011
22/11/2011 Centralised - Variation EMEA/H/C/1127/IB/7
Updated with Decision(2012)4213 of 15/06/2012
15/12/2011 Centralised - Variation EMEA/H/C/1127/IB/9
Updated with Decision(2012)4213 of 15/06/2012
28/03/2012 Centralised - Variation EMEA/H/C/1127/IB/11/G
Updated with Decision(2012)4213 of 15/06/2012
15/06/2012 Centralised - Variation EMEA/H/C/1127/IB/12
Updated with Decision(2012)7756 of 25/10/2012
20/06/2012 Centralised - Variation (2012)4213 of 15/06/2012
05/09/2012 Centralised - Variation EMEA/H/C/1127/IB/14
Updated with Decision(2012)7756 of 25/10/2012
12/11/2012 Centralised - Variation (2012)7756 of 25/10/2012
19/12/2012 Centralised - Variation EMEA/H/C/1127/IB/15
Updated with Decision(2013)9485 of 13/12/2013
10/04/2013 Centralised - Variation EMEA/H/C/1127/IB/17
Updated with Decision(2013)9485 of 13/12/2013
17/12/2013 Centralised - Yearly update (2013)9485 of 13/12/2013
13/03/2014 Centralised - Variation EMEA/H/C/1127/IB/18
Updated with Decision(2014)8895 of 19/11/2014
07/05/2014 Centralised - Variation EMEA/H/C/1127/IAin/19/G
Updated with Decision(2014)8895 of 19/11/2014
08/05/2014 Centralised - Variation EMEA/H/C/1127/IAin/21/G
Updated with Decision(2014)8895 of 19/11/2014
08/08/2014 Centralised - Variation EMEA/H/C/1127/IB/23
Updated with Decision(2014)8895 of 19/11/2014
21/11/2014 Centralised - Renewal EMEA/H/C/1127/R/22 (2014)8895 of 19/11/2014