Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Temomedac   
Auth. number : EU/1/09/605
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: medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6, D-22880 Wedel, 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
27/01/2010 Centralised - Authorisation EMEA/H/C/1124 (2010)531 of 25/01/2010
30/03/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1124/T/1 (2010)2156 of 26/03/2010
27/04/2010 Centralised - Variation EMEA/H/C/1124/IA/2/G
Updated with Decision(2011)412 of 21/01/2011
21/05/2010 Centralised - Variation EMEA/H/C/1124/IB/3
Updated with Decision(2011)412 of 21/01/2011
04/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1124/IB/4/G
26/01/2011 Centralised - Variation (2011)412 of 21/01/2011
30/06/2011 Centralised - Variation EMEA/H/C/1124/IA/5
Updated with Decision(2011)6648 of 19/09/2011
22/09/2011 Centralised - Variation (2011)6648 of 19/09/2011
07/10/2011 Centralised - Variation EMEA/H/C/1124/IB/9
Updated with Decision(2012)2912 of 24/04/2012
13/10/2011 Centralised - Variation EMEA/H/C/1124/IB/7/G
Updated with Decision(2012)2912 of 24/04/2012
27/04/2012 Centralised - Variation (2012)2912 of 24/04/2012
05/09/2012 Centralised - Variation EMEA/H/C/1124/IB/11
Updated with Decision(2012)7746 of 25/10/2012
29/10/2012 Centralised - Variation (2012)7746 of 25/10/2012
10/04/2013 Centralised - Variation EMEA/H/C/1124/IB/15
Updated with Decision(2014)2251 of 31/03/2014
21/01/2014 Centralised - Variation EMEA/H/C/1124/IB/17
Updated with Decision(2014)2251 of 31/03/2014
02/04/2014 Centralised - Yearly update (2014)2251 of 31/03/2014
22/07/2014 Centralised - Renewal EMEA/H/C/1124/R/18 (2014)5250 of 18/07/2014
21/08/2014 Centralised - Variation EMEA/H/C/1124/I/B19
09/09/2014 Centralised - Variation EMEA/H/C/1124/IA/20