Approval · Notice of Compliance 2364 · 2001
AMBISOME: Notice of Compliance 2364
Issued November 19, 2001
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
- 2364
- Date
- November 19, 2001
- Company
- Fujisawa Canada Inc.Markham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indications: empirical therapy for presumed fungal infection in febril, neutropenic patients, and treatment of cryptococcal meningitis in immunocompromised patients
- Therapeutic class
- Antifungal
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AMBISOME | Not yet assigned | — |
Medicinal ingredients
- AMPHOTERICIN B 50 MG per VIAL