EMEA-000116-PIP01-07-M09

Key facts

Invented name
Trobalt
Active substance
retigabine
Therapeutic area
Neurology
Decision number
P/0299/2018
PIP number
EMEA-000116-PIP01-07-M09
Pharmaceutical form(s)
  • Film-coated tablet
  • Dispersible tablet
  • Powder for solution for injection
  • Powder for solution for infusion
  • Chewable tablet
Condition(s) / indication(s)
  • Treatment of epilepsy with partial-onset seizures
  • Treatment of Lennox-Gastaut syndrome
Route(s) of administration
  • Oral use
  • Intravenous use
Contact for public enquiries
Glaxo Group Limited

E-mail: eu.paediatric-plans@gsk.com
Tel. +44 (0)20 8990 3650

Decision type
W: decision granting a waiver in all age groups for all conditions or indications

Decision

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