EMEA-001663-PIP01-14 - paediatric investigation plan

Ibodutant

Key facts

• Active Substance:
  Ibodutant
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0104/2015
• PIP number:
  EMEA-001663-PIP01-14
• Pharmaceutical form(s):
  • Tablet
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of diarrhoea-predominant irritable bowel Syndrome
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Menarini Ricerche S.p.A.

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/05/2015

Decision

P/0104/2015: EMA decision of 11 May 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ibodutant (EMEA-001663-PIP01-14)

Reference Number: EMA/215116/2015