Approval · Notice of Compliance 2153 · 2001
INFANRIX-HIB: Notice of Compliance 2153
Issued August 22, 2001
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
- 2153
- Date
- August 22, 2001
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Change in manufacturer name
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| INFANRIX-HIB | 02241482 | — |
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
- HAEMOPHILUS INFLUENZAE TYPE B-PRP AND TETANUS TOXOID CONJUGATE (PRP-T) 10 MCG per 0.5ML