MHRA-102412-PIP01-26-M01 (update)

Key Facts

Active Substance
  • SODIUM CITRATE
  • CITRIC ACID
  • SIMETICONE
  • SODIUM CHLORIDE
  • POTASSIUM CHLORIDE
  • MACROGOL 4000
  • SODIUM SULPHATE ANHYDROUS
Invented Name
Clensia Powder for oral solution
PIP Number MHRA-102412-PIP01-26-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for oral solution
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Bowel cleansing prior to clinical procedures
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
25/03/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-102412-PIP01-26-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):SODIUM CITRATECITRIC ACIDSIMETICONESODIUM CHLORIDEPOTASSIUM CHLORIDEMACROGOL 4000SODIUM SULPHATE ANHYDROUS.pdf
Published Date 01/05/2026