EMEA-000297-PIP02-12-M02 - paediatric investigation plan

Glycerol phenylbutyrate

Key facts

• Invented name:
  • Ravicti
  • Ravicti
• Active Substance:
  Glycerol phenylbutyrate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0191/2018
• PIP number:
  EMEA-000297-PIP02-12-M02
• Pharmaceutical form(s):
  Oral liquid
• Condition(s) / indication(s):
  Treatment of urea cycle disorders
• Route(s) of administration:
  • Oral use
  • Gastroenteral use
• Contact for public enquiries:

  Horizon Pharma Ireland Limited

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/07/2018
• Compliance procedure number:
  EMEA-C-000297-PIP02-12-M02
• Compliance opinion date:
  21/09/2018
• Compliance outcome:
  Positive

Decision

P/0191/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for glycerol phenylbutyrate (Ravicti), (EMEA-000297-PIP02-12-M02

AdoptedReference Number: EMA/403996/2018