EMEA-001356-PIP02-12-M04

Table of contents

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
Contact for public enquiries
Alfasigma S.p.A.

E-mail: Antonietta.Pazardjiklian@alfasigma.com
Tel.: +39 0516489602
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001356-PIP02-12-M04
Compliance opinion date
17/12/2021
Compliance outcome
positive

Decision

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