MHRA-100332-PIP01-21

Key Facts

PIPS 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

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