MHRA-102050-PIP01-25

Key Facts

Active Substance
Active Substance:
  • Aficamten
Invented Name
Not yet available
PIP Number MHRA-102050-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Tablet
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of hypertrophic cardiomyopathy
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-102050-PIP01-25-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Aficamten.pdf
Published Date 04/03/2026