Approval · Notice of Compliance 3743 · 1997
INFANRIX: Notice of Compliance 3743
Issued September 17, 1997
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
- 3743
- Date
- September 17, 1997
- Company
- Smithkline Beecham Pharma, Division Of Smithkline Beecham Inc.Mississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change in manufacturing
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| INFANRIX | 02230307 | — |
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
- 69 KDA OUTER MEMBRANE PROTEIN 8 MCG per 0.5ML