Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - varicella virus, oka strain, live, attenuated, measles virus, schwarz strain, mumps virus, jeryl lynn, level b, rubella virus, wistar ra - powder and solvent for solution for injection - mumps virus jeryl lynn (level b) strain (live, attenuated) rubella virus - wistar ra27/3 strain varicella virus oka strain (live, attenuated) measles virus - schwarz strain - vaccines

Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - varicella virus, oka strain, live, attenuated, measles virus, schwarz strain, mumps virus, jeryl lynn, level b, rubella virus, wistar ra - powder and solvent for solution for injection in pre-filled syringe - varicella virus oka strain (live, attenuated) measles virus - schwarz strain mumps virus jeryl lynn (level b) strain (live, attenuated) rubella virus wistar ra 27/3 strain (live, attenuated) - vaccines

Ireland - English - HPRA (Health Products Regulatory Authority)

merck sharp & dohme ireland (human health) limited - varicella virus (oka strain) live attenuated - powder and solvent for suspension for injection - =1350 plaque forming unit - varicella, live attenuated

European Union - English - EMA (European Medicines Agency)

zoetis belgium sa - canine distemper virus, strain cdv bio 11/a, canine adenovirus type 2, strain cav-2 bio 13, canine parvovirus type 2b, strain cpv-2b bio 12/b, canine parainfluenza type 2 virus, strain cpiv-2 bio 15 (all live attenuated), leptospira interrogans serogroup australis serovar bratislava, strain mslb 1088, l. interrogans serogroup icterohaemorrhagiae serovar icterohaemorrhagiae, strain mslb 1089, l. interrogans serogroup canicola serovar canicola, strain mslb 1090, l. kirschneri serogroup grippotyphosa serovar grippotyphosa, strain mslb 1091... - live canine distemper virus + live canine adenovirus + live parainfl.virus + live canine parvovirus + inactivated rabies + inactivated leptospira, immunologicals for canidae - dogs - active immunisation of dogs from 8–9 weeks of age:to prevent mortality and clinical signs caused by canine distemper virus,to prevent mortality and clinical signs caused by canine adenovirus type 1,to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2,to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus,to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus,to prevent clinical signs, infection and urinary excretion caused by l. interrogans serogroup australis serovar bratislava,to prevent clinical signs and urinary excretion and reduce infection caused by l. interrogans serogroup canicola serovar canicola and l. interrogans serogroup icterohaemorrhagie serovar icterohaemorrhagiae,to prevent clinical signs and reduce infection and urinary excretion caused by l. interrogans serogroup grippotyphosa serovar grippotyphosa and to prevent mortality, clinical signs and infection caused by rabies virus.

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

medimmune, llc - influenza a virus a/norway/31694/2022 (h1n1) live (attenuated) antigen (unii: fv9fgc9yzw) (influenza a virus a/norway/31694/2022 (h1n1) live (attenuated) antigen - unii:fv9fgc9yzw), influenza a virus a/norway/16606/2021 (h3n2) live (attenuated) antigen (unii: l7z42hp5rz) (influenza a virus a/norway/16606/2021 (h3n2) live (attenuated) antigen - unii:l7z42hp5rz), influenza b virus b/austria/1359417/2021 live (attenuated) antigen (unii: jv6nd6vmy5) (influenza b virus b/austria/1359417/2021 live (attenuated) - influenza a virus a/slovenia/2903/2015 (h1n1) live (attenuated) antigen 10000000 [ffu] in 0.2 ml - flumist®  quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine [see description (11)] . flumist quadrivalent is approved for use in persons 2 through 49 years of age. do not administer flumist quadrivalent to persons who have had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see description (11)] including egg protein, or after a previous dose of any influenza vaccine. do not administer flumist quadrivalent to children and adolescents through 17 years of age who are receiving aspirin therapy or aspirin-containing therapy because of the association of reye’s syndrome with aspirin and wild-type influenza infection [see drug interactions (7.1)] . risk summary flumist quadrivalent is not absorbed systemically following intranasal administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations disease-ass

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

protein sciences corporation - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen (unii: 69h0yj871t) (influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen - unii:69h0yj871t) - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen 45 ug in 0.5 ml

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

glaxosmithkline biologicals sa - influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated) (unii: au5c98u4bb) (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:c46xjt9fq9), influenza a virus a/darwin/6/2021 ivr-227 (h3n2) antigen (formaldehyde inactivated) (unii: f5qv7af326) (influenza a virus a/darwin/6/2021 ivr-227 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:n969qk7xd2), influenza b virus b/austria/1359417/2021 bvr-26 antigen - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 15 ug in 0.5 ml - fluarix quadrivalent is indicated for active immunization for the prevention of disease caused by influenza a subtype viruses and type b viruses contained in the vaccine [see description (11)] . fluarix quadrivalent is approved for use in persons aged 6 months and older. do not administer fluarix quadrivalent to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous administration of any influenza vaccine [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. available data from a pregnancy registry do not suggest an increased risk of major birth defects and miscarriage in individuals who received fluarix quadrivalent within 28 days prior to conception or during pregnancy (see d

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

Ireland - English - HPRA (Health Products Regulatory Authority)

zoetis belgium s.a. - parainfluenza 3 virus, modified live, strain rlb103; bovine respiratory syncytial virus, modified live, strain 375; inactivated bovine viral diarrhoea virus 1, strain 5960 (cytopathic); inactivated bovine viral diarrhoea virus type 1 strain 6309 (non cytopathic) - lyophilisate and suspension for suspension for injection - 10^5.0 - 10^8.6 cell culture infective dose 50/dose - live and inactivated viral vaccines - cattle - immunological - mixed vaccine (l & a)

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

catalent belgium sa - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) antigen (propiolactone inactivated) (unii: v8pc20ubcn) (influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:wlsrj8jc6s) - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) antigen (propiolactone inactivated) 15 ug in 0.5 ml