Approval · Notice of Compliance 10241 · 2009
TRACLEER: Notice of Compliance 10241
Issued June 5, 2009
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 10241
- Date
- June 5, 2009
- Company
- Actelion Pharmaceuticals LtdAllschwil, Basel-Landschaft, Switzerland
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To extend the currently approved indication to include the treatment of pulmonary arterial hypertension in patients with WHO functional class II
- Therapeutic class
- Endothelin receptor antagonist
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRACLEER | Not yet assigned | — |
Medicinal ingredients
- BOSENTAN MONOHYDRATE 62.5 MG per TAB
- BOSENTAN MONOHYDRATE 125 MG per TAB