MHRA-100332-PIP01-21

Key Facts

Active Substance
Active Substance:
  • sotatercept
Invented Name
Not yet available
PIP Number MHRA-100332-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for solution for injection
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of pulmonary arterial hypertension
Route(s) of administration
Route(s) of administration:
  • Parenteral 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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):sotatercept.pdf
Published Date 27/09/2022