Trobalt

Withdrawn

This medicine's authorisation has been withdrawn

retigabine

Overview

On 19 July 2018, the European Commission withdrew the marketing authorisation for Trobalt (retigabine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Glaxo Group Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Trobalt was granted marketing authorisation in the EU on 28 March 2011 for adjunctive treatment of partial onset seizures. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2016. 

The European Public Assessment Report (EPAR) for Trobalt is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Trobalt : EPAR - Summary for the public

Product information

Trobalt : EPAR - Product Information

Trobalt : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Trobalt
• Active substance:
  retigabine
• International non-proprietary name (INN) or common name:
  retigabine
• Therapeutic area (MeSH):
  Epilepsy
• Anatomical therapeutic chemical (ATC) code:
  N03AX21

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Trobalt is indicated as adjunctive treatment of drug-resistant partial-onset seizures with or without secondary generalisation in patients aged 18 years or older with epilepsy, where other appropriate drug combinations have proved inadequate or have not been tolerated.

Authorisation details

• EMA product number:
  EMEA/H/C/001245
• Marketing authorisation holder:
  Glaxo Group Limited

  Glaxo Group Limited; 980 Great West Road; Brentford; Middlesex; TW8 9GS; United Kingdom

• Marketing authorisation issued:
  27/03/2011
• Withdrawal of marketing authorisation:
  19/07/2018
• Revision:
  12

Assessment history

Changes since initial authorisation of medicine

Trobalt : EPAR - Procedural steps taken and scientific information after authorisation

Trobalt-H-C-1245-II-0014 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/59744/2013

Initial marketing authorisation documents

Trobalt : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/207154/2011

CHMP summary of positive opinion for Trobalt

Adopted Reference Number: EMA/31145/2011