EMEA-000927-PIP01-10-M08 - paediatric investigation plan

linaclotide

Key facts

• Invented name:
  Constella
• Active Substance:
  linaclotide
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  P/0529/2022
• PIP number:
  EMEA-000927-PIP01-10-M08
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of functional constipation
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2024

Decision

P/0207/2024: EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for linaclotide (Constella) (EMEA-000927-PIP01-10-M08)

Adopted