Approval · Notice of Compliance 22557 · 2019
FLUAD: Notice of Compliance 22557
Issued August 19, 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
- 22557
- Date
- August 19, 2019
- Company
- Seqirus Uk LimitedMaidenhead, Berkshire, United Kingdom
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- Labelling update
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUAD | Not yet assigned | — |
| FLUAD PEDIATRIC | Not yet assigned | — |
Medicinal ingredients
- HAEMAGGLUTININ-STRAIN A(H1N1) 15 MCG per 0.5ML
- HAEMAGGLUTININ-STRAIN A(H3N2) 15 MCG per 0.5ML
- HAEMAGGLUTININ-STRAIN B 15 MCG per 0.5ML
- HAEMAGGLUTININ-STRAIN A(H1N1) 7.5 MCG per 0.25ML
- HAEMAGGLUTININ-STRAIN A(H3N2) 7.5 MCG per 0.25ML
- HAEMAGGLUTININ-STRAIN B 7.5 MCG per 0.25ML