European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - a/indonesia/05/2005 (h5n1) like strain used (pr8-ibcdc-rg2) - 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 with h5n1 subtype strains.prepandrix should be used in accordance with official guidance.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - influenza virus haemagglutinin 15ug (a h1n1 - strain to be confirmed prior to marketing); influenza virus type a haemagglutinin 15ug (h3n2 - strain to be confirmed prior to marketing); influenza virus type b haemagglutinin 15ug (strain to be confirmed prior to marketing) - suspension for injection - 15 mcg - active: influenza virus haemagglutinin 15ug (a h1n1 - strain to be confirmed prior to marketing) influenza virus type a haemagglutinin 15ug (h3n2 - strain to be confirmed prior to marketing) influenza virus type b haemagglutinin 15ug (strain to be confirmed prior to marketing) excipient: dibasic sodium phosphate dihydrate hydrochloric acid monobasic potassium phosphate potassium chloride sodium chloride sodium hydroxide water for injection

European Union - English - EMA (European Medicines Agency)

ceva santé animale - inactivated influenza-a virus / swine - immunologicals - pigs - active immunisation of pigs from the age of 56 days onwards, including pregnant sows, against swine influenza caused by subtypes h1n1, h3n2 and h1n2 to reduce clinical signs and viral lung load after infection.onset of immunity: 7 days after primary vaccinationduration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity, which provides clinical protection of piglets for at least 33 days after birth.

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

seqirus pty ltd - influenza virus haemagglutinin -

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

pfizer ltd - influenza virus split virion - suspension for injection

Israel - English - Ministry of Health

sanofi israel ltd - a/darwin/9/2021 (h3n2)-like virus; a/victoria/4897/2022 (h1n1)pdm09-like virus; b/austria/1359417/2021 (b/victoria lineage)-like virus; b/phuket/3073/2013 (b/yamagata lineage)-like virus - suspension for injection - b/phuket/3073/2013 (b/yamagata lineage)-like virus 30 mcg ha / 1 ml; a/darwin/9/2021 (h3n2)-like virus 30 mcg ha / 1 ml; b/austria/1359417/2021 (b/victoria lineage)-like virus 30 mcg ha / 1 ml; a/victoria/4897/2022 (h1n1)pdm09-like virus 30 mcg ha / 1 ml - influenza, inactivated, split virus or surface antigen - vaxigrip tetra is indicated for the prevention of influenza disease caused by the two influenza a virus subtypes and the two influenza b virus types contained in the vaccine for:- active immunisation of adults, including pregnant women, and children from 6 months of age and older- passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women.the use of vaxigrip tetra should be based on 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

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

seqirus pty ltd - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) antigen (propiolactone inactivated) (unii: 9jwn7vdq7n) (influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:u6c4gj6wzg), influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) antigen (propiolactone inactivated) (unii: a5wli8wk8a) (influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:37h6eg2naq), influenza b vi - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - afluria® is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and type b present in the vaccine. afluria is approved for use in persons 5 years of age and older. afluria is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11]) . pregnancy category b: a reproductive and developmental toxicity study has been performed in female rats at a dose approximately 265 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to afluria. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, afluria should be given to a pregnant woman only if clearly needed. in the reproductive and developmental toxicity study, the effect

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

deseret biologicals, inc. - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) antigen (propiolactone inactivated) (unii: 9jwn7vdq7n) (influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:u6c4gj6wzg), influenza a virus a/hong kong/4801/2014 x-263b (h3n2) antigen (propiolactone inactivated) (unii: 3dzy3q314e) (influenza a virus a/hong kong/4801/2014 x-263b (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:c2c4da5k06), influenza b virus b/brisbane/60/20 - influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) antigen (propiolactone inactivated) 12 [hp_x] in 1 ml - for temporary relief of symptoms related to general viral infection (such as influenza, epstein-barr virus [ebv], cytomegalovirus [cmv], hepatitis, herpes, or adenovirus) including fever, fatigue, muscle aches and pain, rash, cold sores, headache and confusion.** **these statements are based upon traditional homeopathic principles. they have not been reviewed by the food and drug administration. for temporary relief of symptoms related to general viral infection (such as influenza, epstein-barr virus [ebv], cytomegalovirus [cmv], hepatitis, herpes, or adenovirus) including fever, fatigue, muscle aches and pain, rash, cold sores, headache and confusion.** **these statements are based upon traditional homeopathic principles. they have not been reviewed by the food and drug administration.

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