Approval · Notice of Compliance 13090 · 2012
ARZERRA: Notice of Compliance 13090
Issued March 9, 2012
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 13090
- Date
- March 9, 2012
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Antineoplastic Agent
- With conditions
- Yes (NOC/c)
Products in this notice
Medicinal ingredients
- OFATUMUMAB 100 MG per 5ML
- OFATUMUMAB 1,000 MG per 50ML