Approval · Notice of Compliance 20134 · 2017
ROTATEQ: Notice of Compliance 20134
Issued December 8, 2017
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
- 20134
- Date
- December 8, 2017
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Additional drug substance manufacturing facility
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ROTATEQ | Not yet assigned | — |
Medicinal ingredients
- ROTAVIRUS VACCINE, LIVE, ORAL, TYPE G1 (HUMAN) 22,000,000 UNIT per DOSE
- ROTAVIRUS VACCINE, LIVE, ORAL, TYPE G2 (HUMAN) 28,000,000 UNIT per DOSE
- ROTAVIRUS VACCINE, LIVE, ORAL, TYPE G3 (HUMAN) 22,000,000 UNIT per DOSE
- ROTAVIRUS VACCINE, LIVE, ORAL, TYPE G4 (HUMAN) 23,000,000 UNIT per DOSE
- ROTAVIRUS VACCINE, LIVE, ORAL, TYPE P1(8) (HUMAN) 23,000,000 UNIT per DOSE