ApprovalTrail

Ingredient

Macitentan

Products in Health Canada’s databases that list Macitentan as a medicinal or active ingredient, under this spelling. The same substance can be listed under another name (a salt, a common name), which has its own page.

Drug products
3
3 authorized now
Natural health products
0
0 active licences
Notices of Compliance
12
Products in all
3

Drug products

Authorized products first.

NameDINStatus
OPSUMIT (10 MG)02415690Marketed
OPSUMIT (2.5 MG)02561069Marketed
OPSYNVI (10 MG)02521083Marketed

Notices of Compliance

Approvals of drug submissions that list it, newest first.

  • OPSUMITSeptember 12, 2025 · NOC 35996
  • OPSYNVIMarch 21, 2025 · NOC 35061
  • OPSYNVIApril 26, 2024 · NOC 33125
  • OPSUMITNovember 28, 2022 · NOC 29572
  • OPSYNVISeptember 6, 2022 · NOC 28900
  • OPSUMITSeptember 6, 2022 · NOC 28902
  • OPSYNVIOctober 14, 2021 · NOC 26835
  • OPSUMITApril 16, 2021 · NOC 25686
  • OPSUMITJuly 23, 2020 · NOC 23939
  • OPSUMITAugust 12, 2019 · NOC 22525
  • OPSUMITNovember 28, 2018 · NOC 21572
  • OPSUMITNovember 6, 2013 · NOC 14884