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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Naloxegol (as naloxegol oxalate).pdf
Published Date 18/03/2022