EMEA-000927-PIP01-10-M07 - paediatric investigation plan

linaclotide

Key facts

• Invented name:
  Constella
• Active Substance:
  linaclotide
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0529/2022
• PIP number:
  EMEA-000927-PIP01-10-M07
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of functional constipation
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  AbbVie Ltd

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/12/2022

Decision

P/0529/2022: EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for linaclotide (Constella), (EMEA-000927-PIP01-10-M07)

AdoptedReference Number: EMA/929775/2022