Trobalt
Withdrawn
This medicine's authorisation has been withdrawn
retigabine
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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Assessment Report (EPAR) for Trobalt is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
IAIN/0043
19/07/2018
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
AntiepilepticsTherapeutic 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.
News on Trobalt
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