Approval · Notice of Compliance 19335 · 2017
FLUAD: Notice of Compliance 19335
Issued May 23, 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
- 19335
- Date
- May 23, 2017
- Company
- Seqirus Uk LimitedMaidenhead, Berkshire, United Kingdom
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Merger - buyout
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUAD | 02362384 | Marketed |
| FLUAD PEDIATRIC | 02434881 | Dormant |
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