MHRA-101008-PIP01-23-M02 (update)

Key Facts

Active Substance
Active Substance:
  • AMBRISENTAN
Invented Name
  • Volibris
  • Volibris
PIP Number MHRA-101008-PIP01-23-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of pulmonary arterial hypertension.
Route(s) of administration
Route(s) of administration:
  • Oral 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 opinion date
10/09/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101008-PIP01-23-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):AMBRISENTAN.pdf
Published Date 20/10/2026