MHRA-102258-PIP01-25

Key Facts

PIPS Key Facts
Active Substance
  • LEVODOPA
  • CARBIDOPA MONOHYDRATE
Invented Name
Crexont
PIP Number MHRA-102258-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Modified-release capsule, hard
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of Parkinson’s disease
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
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):LEVODOPACARBIDOPA MONOHYDRATE.pdf
Published Date 06/07/2026