Approval · Notice of Compliance 14033 · 2013
ROTARIX: Notice of Compliance 14033
Issued January 22, 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.
- Notice number
- 14033
- Date
- January 22, 2013
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change to manufacturing process
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ROTARIX | Not yet assigned | — |
Medicinal ingredients
- ROTAVIRUS VACCINE (RIX4414 STRAIN), LIVE, ORAL, ATTENUATED (HUMAN) 10,000,000 CCID50 per 1.5ML