MHRA-101739-PIP01-24-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
  • ASCORBIC ACID
  • MACROGOL 3350
  • POTASSIUM CHLORIDE
  • SODIUM ASCORBATE
  • SODIUM CHLORIDE
  • SODIUM SULPHATE
Invented Name
  • PLENVU
  • PLENVU® powder for oral solution
  • PLEINVUE™ Pulver zur Herstellung einer Lösung zum Einnehmen
  • PLENVU® powder for oral solution
  • PLENVU® powder for oral solution
  • Plenvu prašak za oralnu otopinu
  • PLENVU
  • PLENVU® powder for oral solution
  • PLENVU® powder for oral solution
  • PLENVU, poudre pour solution buvable
  • PLENVU® powder for oral solution
  • PLENVU por belsőleges oldathoz
  • PLENVU® powder for oral solution
  • PLENVU® powder for oral solution
  • PLENVU® powder for oral solution
  • PLENVU
  • Pleinvue™ powder for oral solution
  • PLENVU
  • PLENVU® powder for oral solution
  • PLENVU
  • PLENVU® powder for oral solution
  • Plenvu pulbere pentru soluție orală
  • PLENVU
  • Plenvu prašek za peroralno raztopino
  • PLENVU Powder
  • Pleinvue polvo para solución oral
  • PLENVU
  • Plenvu, Pulver
  • PLENVU
  • PLENVU® powder for oral solution
  • PLENVU
  • PLENVU Powder for oral solution
  • PLENVU Powder for oral solution
  • PLENVU, POLVO PARA SOLUCIÓN ORAL
  • PLENVU, POLVO PARA SOLUCIÓN ORAL
  • PLENVU, POLVO PARA SOLUCIÓN ORAL
  • PLENVU POLVO PARA SOLUCIÓN ORAL
  • PLENVU, POLVO PARA SOLUCIÓN ORAL
  • PLENVU, POLVO PARA SOLUCIÓN ORAL
  • PLENVU, powder for oral solution
  • PLENVU
PIP Number MHRA-101739-PIP01-24-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
  • Oral use
  • Gastric use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ASCORBIC ACIDMACROGOL 3350POTASSIUM CHLORIDESODIUM ASCORBATESODIUM CHLORIDESODIUM SULPHATE.pdf
Published Date 02/05/2025