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

sanofi-aventis australia pty ltd - influenza virus haemagglutinin, quantity: 60 microgram - injection, suspension - excipient ingredients: octoxinol 9; monobasic sodium phosphate; water for injections; dibasic sodium phosphate; sodium chloride - fluzone high-dose quadrivalent (qiv) is indicated for active immunisation for the prevention of influenza disease. fluzone high-dose quadrivalent is indicated for use in persons 60 years of age and older., the use of fluzone high-dose quadrivalent (qiv) should be based on official recommendations., see section 5.1 clinical trials for information on the effects on influenza associated complications.

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

Malta - English - Medicines Authority

abbott biologicals b.v. - influenza vaccine (split virion, inactivated) 15 µg - suspension for injection in pre-filled syringe

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

European Union - English - EMA (European Medicines Agency)

sanofi pasteur s.a. - influenza virus (inactivated, split) of the following strains:a/california/7/2009 (h1n1)pdm09 - like strain (a/california/7/2009, nymc x-179a)a/hong kong/4801/2014 (h3n2) - like strain (a/hong kong/4801/2014, nymc x-263b)b/brisbane/60/2008 - like strain (b/brisbane/60/2008, wild type) - influenza, human; immunization - vaccines - prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.the use of idflu should be based on official recommendations.

European Union - English - EMA (European Medicines Agency)

sanofi pasteur europe - influenza virus (inactivated, split) of the following strains:a/california/7/2009 (h1n1)pdm09 - like strain (a/california/7/2009, nymc x-179a)a/hong kong/4801/2014 (h3n2) - like strain (a/hong kong/4801/2014, nymc x-263b)b/brisbane/60/2008 - like strain (b/brisbane/60/2008, wild type) - influenza, human; immunization - vaccines - prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.the use of intanza should be based on official recommendations.

Malta - English - Medicines Authority

mylan products limited - influenza vaccine (split virion, inactivated) - suspension for injection in pre-filled syringe - influenza vaccine (split virion, inactivated) 15 µg - vaccines

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

split virion, inactivated) high dose suspension for injection 0.5ml pre-filled syringes (sanofi pasteur - influenza virus inactivated split (h1n1, h3n2-like, b/brisbane/60/2008-like, strains) - suspension for injection

Malta - English - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - influenza vaccine, split virion, inactivated - suspension for injection in pre-filled syringe - influenza vaccine (split virion, inactivated) 15 µg - vaccines

European Union - English - EMA (European Medicines Agency)

seqirus s.r.l.  - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - 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/turkey/turkey/1/05 (h5n1)-like strain.aflunov should be used in accordance with official recommendations.