Source: European Medicines Agency (EU) Revision Year: 2015 Publisher: Novartis Vaccines and Diagnostics S.r.l. - Via Fiorentina, 1 – Siena, Italy
Focetria suspension for injection in pre-filled syringe.
Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted).
| Pharmaceutical Form |
|---|
|
Suspension for injection in pre-filled syringe. Milky-white liquid. |
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/07/2009 (H1N1)-derived strain used NYMC X-181 7.5 micrograms** per 0.5 ml dose.
* propagated in eggs
** expressed in microgram haemagglutinin.
Adjuvant MF59C.1 containing:
squalene 9.75 milligrams
polysorbate 80 1.175 milligrams
sorbitan trioleate 1.175 milligrams
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Influenza, inactivated, split virus |
|
| List of Excipients |
|---|
|
Sodium chloride, For the adjuvant, see section 2. |
0.5 ml in pre-filled syringe (type I glass) with plunger-stopper (bromo-butyl rubber). Packs of 1 and 10.
Not all pack sizes may be marketed.
Novartis Vaccines and Diagnostics S.r.l. - Via Fiorentina, 1 – Siena, Italy
EU/1/07/385/001
EU/1/07/385/002
12 August 2010
| Drug | Countries | |
|---|---|---|
| FOCETRIA | Estonia, Ireland, Lithuania |
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