Influenza vaccine/GSK Canada
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Influenza Virus Vaccine, Trivalent - FluLaval; Fluviral; quadrivalent formulation approved by FDA in Aug. 2013
Status: launched in U.S. in 2006; marketed in Canada
Organizations involved:
ID Biomedical Corp. – Manuf.; R&D; Tech.
GlaxoSmithKline Inc. (GSK) –USA mark.
GlaxoSmithKline plc (GSK) – Parent
AmerisourceBergen Corp. – USA mark.
Shire Biologics, Inc. – Former
Shire Pharmaceutical Group plc – Parent; Former
BioChem Pharma Inc. – Former
IAF BioChem Intl. Inc. – R&D; Tech.; Former
Cross ref.: See the Influenza Vaccine Products entry.
Description: FluLaval, also widely known as Fluviral, is a conventional aqueous trivalent inactivated split influenza virus vaccine. Like other influenza vaccines, the product is manufactured from three selected strains of influenza viruses types A and B cultured in the allantoic cavity of embryonated fertile chicken embyros (eggs). Each of the influenza virus strains is cultured and purified separately. The virus is inactivated with ultraviolet light treatment, followed by formaldehyde treatment, purification by centrifugation, and further virus inactivation with sodium deoxycholate.
FluLaval is available as 5-mL multi
... truncated (just the beginning)
Annual sales (2008; $million): (reserved for subscribers)
Annual sales (2009; $million): (reserved for subscribers)
Annual sales (2010; $million): (reserved for subscribers)
Annual sales (2011; $million): (reserved for subscribers)
Annual sales (2012; $million): (reserved for subscribers)
Index Terms:
Companies involvement:
Partial monograph text:
477 Influenza vaccine/GSK Canada
Nomenclature:
Influenza vaccine/GSK Canada [BIO]
FluLaval [TR]
Fluviral [TR in Canada]
Influenza Virus Vaccine [FDA USAN]
Influenza Virus Vaccine, Trivalent [FDA, likely if approved in U.S.]
NDC 19515-883-07 [NDC]
FDA Class: BLA Biologic
Year of approval (FDA) = 2006
Annual sales (2007; $million): (reserved for subscribers)
Biosimilars/biobetters Data
U.S.A.
European Union (EU)
Biosimilars/biobetters-related U.S. Patents: Reserved for subscribers]
U.S. Patent Expiration Year: Reserved for subscribers
U.S. Biosimilars Data Exclusivity Expiration: Reserved for subscribers
U.S. Biosimilars Orphan Exclusivity Expiration: Reserved for subscribers
U.S. Biosimilars Launchability Year: Reserved for subscribers
U.S. Biobetters Launchability Year: Reserved for subscribers
Biosimilars/biobetters-related EU Patents: Reserved for subscribers
EU Patent Expiration Year: Reserved for subscribers
EU Biosimilars Data Exclusivity Expiration: Reserved for subscribers
EU Biosimilars Orphan Exclusivity Expiration: Reserved for subscribers
EU Biosimilars Launchability Year: Reserved for subscribers
EU Biobetters Launchability Year: Reserved for subscribers
biopharmaceutical products
Biorex-70 resin
chicken source materials
vaccines, inactivated
vaccines, subunit
vaccines, viral
chicken embryo (egg) culture
influenza virus
virus culture
formaldehyde
hemagglutinin (HA) antigen, influenza A virus
leukocyte removal
osteoarthritis
sodium citrate
thimerosal (mercury derivative)
viral inactivation, acid (low pH)
viral inactivation, solvent detergent
accelerated approval (based on surrogate endpoints) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
BHK-21 (C-13)
North American coral snake
priority review status
EU000 Not yet/Never filed with EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM999 Not Available/Not Marketed in EU
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