EMEA-001003-PIP01-10-M02 - paediatric investigation plan

(3aR,4S,7aR)-octahydro-4-hydroxy-4-[(3-methylphenyl)ethynyl]-1H-indole-1-carboxylic acid methyl ester

Key facts

• Active Substance:
  (3aR,4S,7aR)-octahydro-4-hydroxy-4-[(3-methylphenyl)ethynyl]-1H-indole-1-carboxylic acid methyl ester
• Therapeutic area:
  Neurology
• Decision number:
  P/0107/2013
• PIP number:
  EMEA-001003-PIP01-10-M02
• Pharmaceutical form(s):
  • Capsule (hard)
  • Powder for oral suspension
• Condition(s) / indication(s):
  Treatment of fragile-X syndrome
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Ltd

  United Kingdom; E-mail: [e-mail]; Tel. [phone]; Fax [phone];

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/04/2013

Decision

P/0107/2013: EMA decision of 30 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for (3aR,4S,7aR)-octahydro-4-hydroxy-4-[(3-methylphenyl)ethynyl]-1H-indole-1-carboxylic acid methy...

AdoptedReference Number: EMA/203225/2013