Approval · Notice of Compliance 3875 · 1997
ROFERON-A: Notice of Compliance 3875
Issued June 16, 1997
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
- 3875
- Date
- June 16, 1997
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Alternate manufacturing site for albumin (human) free formulation, two new strengths of albumin (human) free formulation
- Therapeutic class
- Biological response modifier
Products in this notice
Medicinal ingredients
- INTERFERON ALPHA-2A 3,000,000 UNIT per ML
- INTERFERON ALPHA-2A 6,000,000 UNIT per ML
- INTERFERON ALPHA-2A 9,000,000 UNIT per 0.9ML
- INTERFERON ALPHA-2A 18,000,000 UNIT per 3ML
- INTERFERON ALPHA-2A 36,000,000 UNIT per ML