Approval · Notice of Compliance 22817 · 2019
SYNFLORIX: Notice of Compliance 22817
Issued October 23, 2019
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
- 22817
- Date
- October 23, 2019
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a drug substance manufacturing site
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SYNFLORIX | Not yet assigned | — |
Medicinal ingredients
- PNEUMOCOCCAL POLYSAC SEROT 1 CONJ TO PROTEIN D CARRIER PROT 1 MCG per 0.5ML
- PNEUMOCOCCAL POLYSAC SEROT 4 CONJ TO PROTEIN D CARRIER PROT 3 MCG per 0.5ML
- PNEUMOCOCCAL POLYSAC SEROT 5 CONJ TO PROTEIN D CARRIER PROT 1 MCG per 0.5ML
- PNEUMOCOCCAL POLYSAC SEROT 6B CONJ TO PROTEIN D CARRIER PROT 1 MCG per 0.5ML
- PNEUMOCOCCAL POLYSAC SEROT 7F CONJ TO PROTEIN D CARRIER PROT 1 MCG per 0.5ML
- PNEUMOCOCCAL POLYSAC SEROT 9V CONJ TO PROTEIN D CARRIER PROT 1 MCG per 0.5ML
- PNEUMOCOCCAL POLYSAC SEROT 14 CONJ TO PROTEIN D CARRIER PROT 1 MCG per 0.5ML
- PNEUMOCOCCAL POLYSAC SEROT 18C CONJ TO TETANUS TOXOID CARRIER PROT 3 MCG per 0.5ML
- PNEUMOCOCCAL POLYSAC SEROT 19F CONJ TO DIPHT TOXOID CARRIER PROT 3 MCG per 0.5ML
- PNEUMOCOCCAL POLYSAC SEROT 23F CONJ TO PROTEIN D CARRIER PROT 1 MCG per 0.5ML