Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Teysuno   
Auth. number : EU/1/11/669
Active substance : Tegafur / gimeracil / oteracil
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01B - Antimetabolites
Chemical subgroup: L01BC - Pyrimidine analogues
Chemical substance: L01BC53 - Tegafur, combinations
(See WHO ATC Index)
Indication: Teysuno is indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin
Marketing Authorisation Holder: Nordic Group B.V.
Siriusdreef 22, NL-2132 WT 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
17/03/2011 Centralised - Authorisation EMEA/H/C/1242 (2011)1789 of 14/03/2011
14/10/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1242/T/3 (2011)7390 of 12/10/2011
07/12/2011 Centralised - Variation EMEA/H/C/1242/IAin/4
Updated with Decision(2012)654 of 31/01/2012
02/02/2012 Centralised - Variation EMEA/H/C/1242/II/2 (2012)654 of 31/01/2012
09/08/2012 Centralised - Variation EMEA/H/C/1242/IAin/7
Updated with Decision(2012)7925 of 29/10/2012
09/08/2012 Centralised - Variation EMEA/H/C/1242/IAin/6
Updated with Decision(2012)7925 of 29/10/2012
06/11/2012 Centralised - Variation (2012)7925 of 29/10/2012
15/11/2012 Centralised - Notification EMEA/H/C/1242/N/8
Updated with Decision(2013)5008 of 26/07/2013
31/07/2013 Centralised - Variation EMEA/H/C/1242/PSU/6 (2013)5008 of 26/07/2013
06/09/2013 Centralised - Variation EMEA/H/C/1242/IB/10
Updated with Decision(2014)6092 of 22/08/2014
24/09/2013 Centralised - Variation EMEA/H/C/1242/IAin/12
Updated with Decision(2014)6092 of 22/08/2014
24/10/2013 Centralised - Variation EMEA/H/C/1242/IAin/13/G
Updated with Decision(2014)6092 of 22/08/2014
26/08/2014 Centralised - Yearly update (2014)6092 of 22/08/2014