Approval · Notice of Compliance 9077 · 2007
ROTARIX: Notice of Compliance 9077
Issued October 9, 2007
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
- 9077
- Date
- October 9, 2007
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ROTARIX | 02300591 | Marketed |
Medicinal ingredients
- ROTAVIRUS VACCINE (RIX4414 STRAIN), LIVE, ORAL, ATTENUATED (HUMAN) 10,000,000 CCID50 per ML