Approval · Notice of Compliance 10865 · 2009
ROTATEQ: Notice of Compliance 10865
Issued December 11, 2009
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
- 10865
- Date
- December 11, 2009
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Product Monograph updates
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ROTATEQ | Not yet assigned | — |
Medicinal ingredients
- HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G1 2,210,000 UNIT per DOSE
- HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G2 2,840,000 UNIT per DOSE
- HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G3 2,220,000 UNIT per DOSE
- HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G4 2,040,000 UNIT per DOSE
- HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE P1(8) 2,290,000 UNIT per DOSE