EMEA-001705-PIP02-15-M03 - paediatric investigation plan

sodium sulfate

sodium chloride

sodium ascorbate

potassium chloride (NER1006)

ascorbic acid

polyethylene glycol 3350

Key facts

• Invented name:
  Plenvu
• Active substance:
  • sodium sulfate
  • sodium chloride
  • sodium ascorbate
  • potassium chloride (NER1006)
  • ascorbic acid
  • polyethylene glycol 3350
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0458/2020
• PIP number:
  EMEA-001705-PIP02-15-M03
• Pharmaceutical form(s):
  Powder for oral solution
• Condition(s) / indication(s):
  Bowel cleansing prior to clinical procedures
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2020
• Compliance check done:
  No

Decision

P/0458/2020: EMA decision of 1 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan...(EMEA-001705-PIP02-15-M03)

Adopted Reference Number: EMA/576891/2020