Approval · Notice of Compliance 24430 · 2020
BEXSERO: Notice of Compliance 24430
Issued October 9, 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
- 24430
- Date
- October 9, 2020
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New master cell bank
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BEXSERO | Not yet assigned | — |
Medicinal ingredients
- RECOMBINANT NEISSERIA MENINGITIDIS GRP B NHBA FUSION PROTEIN 100 MCG per ML
- RECOMBINANT NEISSERIA MENINGITIDIS GRP B NADA PROTEIN 100 MCG per ML
- RECOMBINANT NEISSERIA MENINGITIDIS GRP B FHBP FUSION PROTEIN 100 MCG per ML
- OUTER MEMBRANE VESICLES (NEISSERIA MENINGITIDIS GROUP B NZ98/254 STRAIN) 50 MCG per ML