MHRA-100284-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • MEXILETINE HYDROCHLORIDE
Invented Name
  • Namuscla
  • Namuscla
PIP Number MHRA-100284-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Oral solution
Therapeutic area
Therapeutic area:
  • Other: Muscle disorders
Conditions / Indications
Conditions / Indications:
  • Treatment of myotonic disorders
Route(s) of administration
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

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):MEXILETINE HYDROCHLORIDE.pdf
Published Date 30/04/2024