Approval · Notice of Compliance 19025 · 2017
BEXSERO: Notice of Compliance 19025
Issued March 3, 2017
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
- 19025
- Date
- March 3, 2017
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a new manufacturing suite
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 0.5ML
- RECOMBINANT NEISSERIA MENINGITIDIS GRP B NADA PROTEIN 100 MCG per 0.5ML
- RECOMBINANT NEISSERIA MENINGITIDIS GRP B FHBP FUSION PROTEIN 100 MCG per 0.5ML
- OUTER MEMBRANE VESICLES (NEISSERIA MENINGITIDIS GROUP B NZ98/254 STRAIN) 50 MCG per 0.5ML