Approval · Notice of Compliance 14991 · 2013
BEXSERO: Notice of Compliance 14991
Issued December 6, 2013
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
- 14991
- Date
- December 6, 2013
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BEXSERO | 02417030 | Marketed |
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