Approval · Notice of Compliance 2256 · 2001
FLUDARA: Notice of Compliance 2256
Issued October 30, 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
- 2256
- Date
- October 30, 2001
- Company
- Berlex Canada Inc.Pointe-Claire, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: for the use in the treatment of low-grade non-hodgkin's lymphoma (lg-nhl) in patients who have failed other conventional treatment
- Therapeutic class
- Antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUDARA | 01989537 | Cancelled Post Market |
Medicinal ingredients
- FLUDARABINE PHOSPHATE 50 MG per VIAL