Approval · Notice of Compliance 12335 · 2010
PEDIARIX: Notice of Compliance 12335
Issued December 10, 2010
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
- 12335
- Date
- December 10, 2010
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Additional manufacturing facility
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PEDIARIX | Not yet assigned | — |
Medicinal ingredients
- PERTUSSIS TOXOID 25 MCG per 0.5ML
- FILAMENTOUS HAEMAGGLUTININ 25 MCG per 0.5ML
- PERTACTIN 8 MCG per 0.5ML
- DIPHTHERIA TOXOID 25 LF per 0.5ML
- TETANUS TOXOID 10 LF per 0.5ML
- HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCG per 0.5ML
- INACTIVATED POLIOVIRUS TYPE I 40 UNIT per 0.5ML
- INACTIVATED POLIOVIRUS TYPE II 8 UNIT per 0.5ML
- INACTIVATED POLIOVIRUS TYPE III 32 UNIT per 0.5ML