MHRA-100168-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Naloxegol (as naloxegol oxalate)
Invented Name
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
PIP Number MHRA-100168-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Age appropriate liquid formulation
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of opioid-induced constipation
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Kyowa Kirin Pharmaceutical Development Limited
  • Country United Kingdom
  • Tel 01896664000
  • Email medinfo@kyowakirin.com
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
14/07/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100168-PIP01-21-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Naloxegol (as naloxegol oxalate).pdf
Published Date 14/04/2026