Approval · Notice of Compliance 16153 · 2014
ARZERRA: Notice of Compliance 16153
Issued October 2, 2014
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
- 16153
- Date
- October 2, 2014
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Additional indicatgion: in combination with chloramucil, for the treatment of patients with chronic lymphocytic leukemia (cll) who have nor received prior therapy and for whom fludarabine-based therapy is considered inappropriate. revised indication: for the treatment of patients with cll refractory to fludarabine and alemtuzumab. the efficacy of arzerra in the treatment of refratcory cll is based on the demonstration of durable objective responses. no data demonstrate an improvement in disease related symptoms or increases survival with arzerra
- Therapeutic class
- Antineoplastic agent
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ARZERRA | Not yet assigned | — |
Medicinal ingredients
- OFATUMUMAB 20 MG per ML