Nitisinone
Products in Health Canada’s databases that list Nitisinone 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
- 12
- 9 authorized now
- Natural health products
- 0
- 0 active licences
- Notices of Compliance
- 9
- Products in all
- 12
Drug products
Authorized products first.
| Name | DIN | Status | Holder | Status since |
|---|---|---|---|---|
| MDK-NITISINONE (2 MG) | 02457717 | Marketed | Mendelikabs Inc | |
| MDK-NITISINONE (5 MG) | 02457725 | Marketed | Mendelikabs Inc | |
| MDK-NITISINONE (10 MG) | 02457733 | Marketed | Mendelikabs Inc | |
| ORFADIN (2 MG) | 02459698 | Marketed | Swedish Orphan Biovitrum Ab (Publ) | |
| ORFADIN (5 MG) | 02459701 | Marketed | Swedish Orphan Biovitrum Ab (Publ) | |
| ORFADIN (10 MG) | 02459728 | Marketed | Swedish Orphan Biovitrum Ab (Publ) | |
| ORFADIN (20 MG) | 02459736 | Marketed | Swedish Orphan Biovitrum Ab (Publ) | |
| ORFADIN (4 MG) | 02469693 | Marketed | Swedish Orphan Biovitrum Ab (Publ) | |
| MDK-NITISINONE (20 MG) | 02470055 | Dormant | Mendelikabs Inc | |
| NITISINONE TABLETS (2 MG) | 02458616 | Cancelled Post Market | Cycle Pharmaceuticals Ltd | |
| NITISINONE TABLETS (5 MG) | 02458624 | Cancelled Post Market | Cycle Pharmaceuticals Ltd | |
| NITISINONE TABLETS (10 MG) | 02458632 | Cancelled Post Market | Cycle Pharmaceuticals Ltd |
Notices of Compliance
Approvals of drug submissions that list it, newest first.
- ORFADINOctober 7, 2022 · NOC 29171
- NITISINONE TABLETSJune 9, 2022 · NOC 28370
- NITISINONE TABLETSOctober 15, 2019 · NOC 22777
- ORFADINMarch 27, 2018 · NOC 20668
- MDK-NITISINONENovember 30, 2017 · NOC 20103
- ORFADINNovember 14, 2017 · NOC 20058
- ORFADINDecember 13, 2016 · NOC 18759
- NITISINONE TABLETSNovember 4, 2016 · NOC 18637
- MDK-NITISINONESeptember 20, 2016 · NOC 18498