Approval · Notice of Compliance 478 · 2003
CAELYX: Notice of Compliance 478
Issued June 9, 2003
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
- 478
- Date
- June 9, 2003
- Company
- Schering Canada Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk
- Therapeutic class
- Antineoplastic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CAELYX | Not yet assigned | — |
Medicinal ingredients
- DOXORUBICIN HYDROCHLORIDE 2 MG per ML