European Union - English - EMA (European Medicines Agency)

resilience biomanufacturing ireland limited - influenza vaccine (whole virion, inactivated) containing antigen of: a/vietnam/1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaccines - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance.

European Union - English - EMA (European Medicines Agency)

ology bioservices ireland ltd - influenza virus (whole virion, inactivated), containing antigen of: a/vietnam/1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - influenza vaccines - active immunisation against h5n1 subtype of influenza a virus. this indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with h5n1 subtype strains. vepacel should be used in accordance with official guidance.,

European Union - English - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human, immunization, disease outbreaks - vaccines, - active immunisation against h5n1 subtype of influenza a virus., this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain., prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.,

United States - English - NLM (National Library of Medicine)

novartis vaccines and diagnostics ltd - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) (unii: k9p8pva2ug) (influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) - unii:k9p8pva2ug) - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - influenza a (h1n1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza disease caused by pandemic (h1n1) 2009 virus. influenza a (h1n1) 2009 monovalent vaccine should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of influenza a (h1n1) 2009 monovalent vaccine, or who has had a life-threatening reaction to previous influenza vaccinations [see description (11)]. novartis’ influenza a (h1n1) 2009 monovalent vaccine and seasonal trivalent influenza virus vaccine (fluvirin) are manufactured by the same process. available information for fluvirin is provided in this section. pregnancy category c: animal reproduction studies have not been conducted with influenza a (h1n1) 2009 monovalent vaccine or fluvirin. it is also not known whether influenza a (h1n1) 2009 monovalent vaccine or fluvirin can cause fetal harm when administered to

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - influenza, human; immunization; disease outbreaks - vaccines - active immunisation against h5n1 subtype of influenza a virus.this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from a/vietnam/1194/2004 nibrg-14 (h5n1) (see section 5.1).prepandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals 3.75 µg should be used in accordance with official guidance.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - reassortant influenza virus (live attenuated) of the following strain: a/vietnam/1203/2004 (h5n1) strain - influenza, human - vaccines - prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age.pandemic influenza vaccine h5n1 astrazeneca should be used in accordance with official guidance

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - influenza, human, immunization, disease outbreaks - vaccines, - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance.,

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - influenza, human - vaccines - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance.

Australia - English - Department of Health (Therapeutic Goods Administration)

au pharma pty ltd - influenza virus haemagglutinin, quantity: 15 microgram/ml - injection, suspension - excipient ingredients: trometamol; water for injections; sodium chloride; polysorbate 80 - pandemic influenza vaccine h5n1 baxter is indicated for prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official recommendations.

European Union - English - EMA (European Medicines Agency)

seqirus s.r.l.  - zoonotic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - influenza a virus, h5n1 subtype - vaccines - active immunisation against h5 subtype of influenza a virus