EMEA-000116-PIP01-07-M09 - paediatric investigation plan

retigabine

Key facts

• Invented name:
  • Trobalt
  • 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
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/09/2018

Decision

P/0299/2018: EMA decision of 12 September 2018 on the acceptance of a modification of an agreed paediatric investigation plan for retigabine (Trobalt), (EMEA-000116-PIP01-07-M09)

AdoptedReference Number: EMA/584737/2018