EMEA-001668-PIP01-14 - paediatric investigation plan

Macrogol 3350

Key facts

• Active substance:
  Macrogol 3350
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0308/2014
• PIP number:
  EMEA-001668-PIP01-14
• Pharmaceutical form(s):
  Oral powder
• Condition(s) / indication(s):
  Treatment of constipation
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  24/11/2014
• Compliance check done:
  No

Decision

P/0308/2014: EMA decision of 24 November 2014 on the granting of a product specific waiver for macrogol 3350 (EMEA-001668-PIP01-14)

Adopted Reference Number: EMA/642067/2014