EMEA-000245-PIP01-08-M06 - paediatric investigation plan

Lubiprostone

Key facts

• Invented name:
  Amitiza
• Active Substance:
  Lubiprostone
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0363/2019
• PIP number:
  EMEA-000245-PIP01-08-M06
• Pharmaceutical form(s):
  Capsule (soft)
• Condition(s) / indication(s):
  Treatment of constipation
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/11/2019
• Compliance procedure number:
  EMEA-C-000245-PIP01-08-M06
• Compliance opinion date:
  28/02/2020
• Compliance outcome:
  Positive

Decision

P/0363/2019: EMA decision of 4 November 2019 on the acceptance of a modification of an agreed paediatric investigation plan for lubiprostone (AMITIZA), (EMEA-000245-PIP01-08-M06)

Reference Number: EMA/585843/2019