Approval · Notice of Compliance 14358 · 2013
ARZERRA: Notice of Compliance 14358
Issued May 10, 2013
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
- 14358
- Date
- May 10, 2013
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfill commitment number one (1) of the letter of Undertaking
- Therapeutic class
- Antineoplastic agent
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ARZERRA | Not yet assigned | — |
Medicinal ingredients
- OFATUMUMAB 100 MG per 5ML
- OFATUMUMAB 1,000 MG per 50ML