Approval · Notice of Compliance 7548 · 2005
INFANRIX-IPV: Notice of Compliance 7548
Issued October 11, 2005
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
- 7548
- Date
- October 11, 2005
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Improved manufacturing process
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| INFANRIX-IPV | Not yet assigned | — |
Medicinal ingredients
- DIPHTHERIA TOXOID 30 UNIT per 0.5ML
- TETANUS TOXOID 40 UNIT per 0.5ML
- PERTUSSIS TOXOID 25 MCG per 0.5ML
- FILAMENTOUS HAEMAGGLUTININ 25 MCG per 0.5ML
- PERTACTIN 8 MCG per 0.5ML
- INACTIVATED POLIOMYELITIS VACCINE (D.C.O) TYPE 1 MAHONEY 40 DU per 0.5ML
- INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 M.E.F.1 8 DU per 0.5ML
- INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT 32 DU per 0.5ML