EMEA-001461-PIP02-14 - paediatric investigation plan

acotiamide

Key facts

• Active Substance:
  acotiamide
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0218/2015
• PIP number:
  EMEA-001461-PIP02-14
• Pharmaceutical form(s):
  Coated tablet
• Condition(s) / indication(s):
  Treatment of functional dyspepsia
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  02/10/2015

Decision

P/0218/2015: EMA decision of 2 October 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for acotiamide (EMEA-001461-PIP02-14)

AdoptedReference Number: EMA/561659/2015