EMEA-000459-PIP01-08-M02 - paediatric investigation plan

Prucalopride succinate

Key facts

• Invented name:
  Resolor
• Active Substance:
  Prucalopride succinate
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0293/2012
• PIP number:
  EMEA-000459-PIP01-08-M02
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral solution
• Condition(s) / indication(s):
  • Treatment of chronic constipation
  • Treatment of opioid-induced constipation
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Takeda Pharmaceuticals International AG Ireland Branch

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  18/12/2012
• Compliance procedure number:
  EMEA-C-000459-PIP01-08-M02
• Compliance opinion date:
  06/12/2013
• Compliance outcome:
  Positive

Decision

P/0293/2012: EMA decision of 18 December 2012 on the acceptance of a modification of an agreed paediatric investigation plan for prucalopride (Resolor), (EMEA-000459-PIP01-08-M02)

AdoptedReference Number: EMA/802543/2012