Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Trobalt   
Auth. number : EU/1/11/681
INN : retigabine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N03 - Antiepileptics
Pharmacological subgroup: N03A - Antiepileptics
Chemical subgroup: N03AX - Other antiepileptics
Chemical substance: N03AX21 - Retigabine
(See WHO ATC Index)
Indication: Adjunctive treatment of drug-resistant partial onset seizures with or without secondary generalization in patients aged 18 years or older with epilepsy, where other appropriate drug combinations have proved inadequate or have not been tolerated.
Marketing Authorisation Holder: Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, 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
29/03/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1245 (2011)2259 of 28/03/2011
31/03/2011 Centralised - Authorisation EMEA/H/C/1245 (2011)2260 of 28/03/2011
12/05/2011 Corrigendum (2011)2260 COR of 06/05/2011
11/11/2011 Centralised - Variation EMEA/H/C/1245/IB/8/G
Updated with Decision(2012)3214 of 10/05/2012
04/04/2012 Centralised - Variation EMEA/H/C/1245/IA/10/G
Updated with Decision(2012)3214 of 10/05/2012
14/05/2012 Centralised - Variation (2012)3214 of 10/05/2012
12/09/2012 Centralised - Variation EMEA/H/C/1245/II/12 (2012)6385 of 10/09/2012
21/02/2013 Centralised - Variation EMEA/H/C/1245/II/15
Updated with Decision(2013)4243 of 01/07/2013
18/04/2013 Centralised - Variation EMEA/H/C/1245/IA/279
Updated with Decision(2013)4243 of 01/07/2013
25/04/2013 Centralised - Variation EMEA/H/C/1245/II/16
Updated with Decision(2013)4243 of 01/07/2013
24/05/2013 Centralised - Variation EMEA/H/C/1245/IB/18
Updated with Decision(2013)4243 of 01/07/2013
03/07/2013 Centralised - Variation EMEA/H/C/1245/II/14 (2013)4243 of 01/07/2013
14/10/2013 Centralised - Variation EMEA/H/C/1245/N/20
Updated with Decision(2014)3133 of 07/05/2014
13/02/2014 Corrigendum (2014)999 of 11/02/2014
20/03/2014 Centralised - Variation EMEA/H/C/1245/II/23
Updated with Decision(2014)3133 of 07/05/2014
09/05/2014 Centralised - Variation EMEA/H/C/1245/II/23 (2014)3133 of 07/05/2014