MHRA-100343-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • MACITENTAN
Invented Name
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Zependo
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Zependo
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
PIP Number MHRA-100343-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Dispersible tablet
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
  • Treatment of pulmonary arterial hypertension
  • systemic sclerosis
  • 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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):MACITENTAN.pdf
Published Date 02/11/2022