MHRA-100284-PIP01-21-M03 (update)

Key Facts

Active Substance
Active Substance:
  • MEXILETINE HYDROCHLORIDE
Invented Name
  • Namuscla
  • Namuscla
PIP Number MHRA-100284-PIP01-21-M03 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Capsule, hard
Therapeutic area
Therapeutic area:
  • Other: Muscle disorders
Conditions / Indications
Conditions / Indications:
  • Treatment of myotonic disorders
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
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100284-PIP01-21-M03-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):MEXILETINE HYDROCHLORIDE.pdf
Published Date 28/10/2024