Approval · Notice of Compliance 3472 · 2003
PHOTOFRIN: Notice of Compliance 3472
Issued March 14, 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
- 3472
- Date
- March 14, 2003
- Company
- Axcan Pharma Inc.Mont St-Hilaire, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: ablation of high-grade dysplasia (hgd) in barrett's esophagus (be) in patients who refuse esophagectomy and are in overall good health
- Therapeutic class
- Antineoplastic photosensitizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PHOTOFRIN | Not yet assigned | — |
Medicinal ingredients
- PORFIMER SODIUM 15 MG per VIAL
- PORFIMER SODIUM 75 MG per VIAL