Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Temozolomide Accord   
Auth. number : EU/1/10/615
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: Temozolomide Accord is indicated for the 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.d adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Marketing Authorisation Holder: Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
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/1125 (2010)1839 of 15/03/2010
03/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1125/IA/2
01/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1125/IA/3
31/05/2011 Centralised - Variation EMEA/H/C/1125/II/1/G (2011)3877 of 27/05/2011
21/10/2011 Centralised - Variation EMEA/H/C/1125/IB/7
Updated with Decision(2012)3598 of 25/05/2012
22/11/2011 Centralised - Variation EMEA/H/C/1125/IB/6
Updated with Decision(2012)3598 of 25/05/2012
31/05/2012 Centralised - Variation (2012)3598 of 25/05/2012
22/06/2012 Centralised - Variation EMEA/H/C/1125/IB/10
Updated with Decision(2012)7744 of 25/10/2012
13/08/2012 Centralised - Notification EMEA/H/C/1125/N/12
Updated with Decision(2012)7744 of 25/10/2012
09/10/2012 Centralised - Variation EMEA/H/C/1125/IB/13
Updated with Decision(2012)7744 of 25/10/2012
29/10/2012 Centralised - Variation (2012)7744 of 25/10/2012
21/11/2012 Centralised - Variation EMEA/H/C/1125/IB/14
Updated with Decision(2014)1467 of 28/02/2014
04/04/2013 Centralised - Variation EMEA/H/C/1125/IB/16
Updated with Decision(2014)1467 of 28/02/2014
12/02/2014 Centralised - Variation EMEA/H/C/1125/IB/25
Updated with Decision(2014)1467 of 28/02/2014
04/03/2014 Centralised - Yearly update (2014)1467 of 28/02/2014
14/08/2014 Centralised - Variation EMEA/H/C/1125/IB/27
Updated with Decision(2015)107 of 12/01/2015
14/01/2015 Centralised - Renewal EMEA/H/C/1125/R/26 (2015)107 of 12/01/2015
18/03/2015 Centralised - Variation EMEA/H/C/1125/IA/30/G
Updated with Decision(2015)3683 of 27/05/2015
29/05/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1125/T/29 (2015)3683 of 27/05/2015
12/06/2015 Centralised - Variation EMEA/H/C/1125/IB/31/G