Approval · Notice of Compliance 23733 · 2020
INFANRIX HEXA: Notice of Compliance 23733
Issued June 3, 2020
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
- 23733
- Date
- June 3, 2020
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Alternate drug substance manufacturing facility
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| INFANRIX HEXA | Not yet assigned | — |
Medicinal ingredients
- DIPHTHERIA TOXOID ADSORBED 25 LF per 0.5ML
- HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCG per 0.5ML
- TETANUS TOXOID ADSORBED 10 LF per 0.5ML
- INACTIVATED POLIOVIRUS TYPE I 40 DU per 0.5ML
- INACTIVATED POLIOVIRUS TYPE II 8 DU per 0.5ML
- INACTIVATED POLIOVIRUS TYPE III 32 DU per 0.5ML
- HAEMOPHILUS INFLUENZAE TYPE B-PRP AND TETANUS TOXOID CONJUGATE (PRP-T) 10 MCG per 0.5ML
- FILAMENTOUS HAEMAGGLUTININ ADSORBED 25 MCG per 0.5ML
- PERTACTIN ADSORBED 8 MCG per 0.5ML
- PERTUSSIS TOXOID ADSORBED 25 MCG per 0.5ML