MHRA-100343-PIP01-21-M04 (update)

Key Facts

Active Substance
Active Substance:
  • MACITENTAN
Invented Name
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
PIP Number MHRA-100343-PIP01-21-M04 (update)
Pharmaceutical form(s)
  • Film-coated tablets
  • Dispersible tablet
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
  • Treatment of pulmonary arterial hypertension
  • Treatment of systemic sclerosis
  • Treatment of idiopathic pulmonary fibrosis
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
05/06/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100343-PIP01-21-M04-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):MACITENTAN.pdf
Published Date 15/08/2024