EMEA-001356-PIP02-12-M04 - paediatric investigation plan

citric acid (as citric acid anhydrous)

macrogol 4000

potassium chloride

simeticone

sodium chloride

sodium citrate

sodium sulfate (as sodium sulfate anhydrous)

Key facts

• Invented name:
  Clensia
• Active Substance:
  • citric acid (as citric acid anhydrous)
  • macrogol 4000
  • potassium chloride
  • simeticone
  • sodium chloride
  • sodium citrate
  • sodium sulfate (as sodium sulfate anhydrous)
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0134/2021
• PIP number:
  EMEA-001356-PIP02-12-M04
• Pharmaceutical form(s):
  Powder for oral suspension
• Condition(s) / indication(s):
  Bowel cleansing prior to clinical procedures
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2021
• Compliance procedure number:
  EMEA-C-001356-PIP02-12-M04
• Compliance opinion date:
  17/12/2021
• Compliance outcome:
  Positive

Decision

P/0134/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed PIP for citric acid / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate / potassium chloride (Clensia)

AdoptedReference Number: EMA/150427/2021