EMEA-001414-PIP01-12-M01 - paediatric investigation plan

Olesoxime

Key facts

• Active Substance:
  Olesoxime
• Therapeutic area:
  Neurology
• Decision number:
  P/0107/2016
• PIP number:
  EMEA-001414-PIP01-12-M01
• Pharmaceutical form(s):
  Age-appropriate oral liquid dosage form
• Condition(s) / indication(s):
  Treatment of spinal muscular atrophy
• Route(s) of administration:
  • Oral use
  • Gastric use
• Contact for public enquiries:

  Roche Registration Limited

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/04/2016

Decision

P/0107/2016: EMA decision of 15 April 2016 on the acceptance of a modification of an agreed paediatric investigation plan for olesoxime (EMEA-001414-PIP01-12-M01)

AdoptedReference Number: EMA/195508/2016