Approval · Notice of Compliance 21204 · 2018
BEXSERO: Notice of Compliance 21204
Issued August 14, 2018
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
- 21204
- Date
- August 14, 2018
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expansion to indication
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BEXSERO | Not yet assigned | — |
Medicinal ingredients
- RECOMBINANT NEISSERIA MENINGITIDIS GRP B NHBA FUSION PROTEIN 50 MCG per 0.5ML
- RECOMBINANT NEISSERIA MENINGITIDIS GRP B NADA PROTEIN 50 MCG per 0.5ML
- RECOMBINANT NEISSERIA MENINGITIDIS GRP B FHBP FUSION PROTEIN 50 MCG per 0.5ML
- OUTER MEMBRANE VESICLES (NEISSERIA MENINGITIDIS GROUP B NZ98/254 STRAIN) 25 MCG per 0.5ML