EMEA-002341-PIP02-23 - paediatric investigation plan

Ganaxolone
PIPHuman

Key facts

Invented name
Ztalmy
Active Substance
Ganaxolone
Therapeutic area
Congenital, familial and genetic disorders
Decision number
P/0183/2024
PIP number
EMEA-002341-PIP02-23
Pharmaceutical form(s)
Oral suspension
Condition(s) / indication(s)
Treatment of tuberous sclerosis complex
Route(s) of administration
  • Oral use
  • Gastric use
Contact for public enquiries

Marinus Pharmaceuticals Inc.

E-mail: regulatory@marinuspharma.com
Tel.  +1 4848014670

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date

Decision

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