European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus inactivated, containing antigen equivalent to a/california/07/2009 (h1n1)-derived strain used nymc x-179a - influenza, human; immunization; disease outbreaks - influenza vaccines - prophylaxis of influenza caused by a (h1n1)v 2009 virus. pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (h1n1)v is considered necessary (see sections 4.4 and 4.8).pandemrix 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/california/7/2009 (h1n1)v like strain (x-179a)*propagated in eggs. - influenza, human; immunization; disease outbreaks - influenza 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)

sanofi pasteur s.a. - split influenza virus, inactivated, containing antigen*: a/california/7/2009 (h1n1)v like strain (x-179a)*propagated in eggs. - 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - a/california/7/2009/(h1n1)pdm - like strain (a/california/7/2009, nymc x-179a), a/texas/50/2012/(h3n2) - like strain (a/texas/50/2012, nymc x-223a), b/brisbane/60/2008 (victoria lineage), b/massachussets/2/2012 (yamagata lineage) - solution for injection in pre-filled syringe - 15 microgram - influenza vaccines

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - influenza virus a/california/7/2009 (h1n1) - like strain 15ug - suspension for injection - 15 mcg/0.5ml - active: influenza virus a/california/7/2009 (h1n1) - like strain 15ug excipient: calcium chloride dihydrate dibasic sodium phosphate monobasic potassium phosphate monobasic sodium phosphate dihydrate potassium chloride sodium chloride thiomersal water for injection - for active immunisation to prevent influenza disease caused by the influenza a(h1n1) virus, in adults, adolescents and children 10 years of age and older.

Canada - English - Health Canada

id biomedical corporation of quebec - haemagglutinin from a/california/7/2009 (h1n1)v-like strain (x-179a) - suspension - 15mcg - haemagglutinin from a/california/7/2009 (h1n1)v-like strain (x-179a) 15mcg - vaccines

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - influenza virus a/california/7/2009 (h1n1) - like strain 9ug (a/california/7/2009 nymc x-179a); influenza virus a/texas/50/2012 (h3n2) like strain 9ug (a/texas/50/2012 nymc x-223a); influenza virus b/massachusetts/2/2012 like strain 9ug (wild type) - suspension for injection - 9 mcg - active: influenza virus a/california/7/2009 (h1n1) - like strain 9ug (a/california/7/2009 nymc x-179a) influenza virus a/texas/50/2012 (h3n2) like strain 9ug (a/texas/50/2012 nymc x-223a) influenza virus b/massachusetts/2/2012 like strain 9ug (wild type) excipient: dibasic sodium phosphate dihydrate hydrochloric acid monobasic potassium phosphate potassium chloride sodium chloride sodium hydroxide water for injection - intanza 9mcg is indicated for prophylaxis of influenza in adults from 18 to 59 years of age. the use of intanza 9mcg in new zealand should be based on the ministry of health recommendations for influenza vaccination as published in the current new zealand immunisation handbook.

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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

split virion, inactivated - influenza virus split virion - suspension for injection

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

split virion, inactivated - influenza virus split virion - suspension for injection