Malta - English - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - a, guangdong, maonan, swl, hong kong, b, washington - suspension for injection in pre-filled syringe - a/guangdong-maonan/swl1536/2019 15 µg a/hong kong/2671/2019 15 µg b/washington/02/2019 15 µg - vaccines

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

seqirus inc. - influenza a virus a/washington/19/2020 (h1n1) antigen (mdck cell derived, propiolactone inactivated) (unii: 3yn85tu9mj) (influenza a virus a/washington/19/2020 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:32ss7wu2j7), influenza a virus a/tasmania/503/2020 (h3n2) antigen (mdck cell derived, propiolactone inactivated) (unii: 6er9j3gb63) (influenza a virus a/tasmania/503/2020 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:bun3xfj2b3), - flucelvax quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. flucelvax quadrivalent is approved for use in persons 6 months of age and older. [see clinical studies (14)] do not administer flucelvax quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the 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. there are insufficient data for flucelvax quadrivalent in pregnant women to inform vaccine-associated risks in pregnancy. there were no developmental toxicity studies of flucelvax quadrivalent performed in animals. a developmental toxicity study has been performed in female r

Ireland - English - HPRA (Health Products Regulatory Authority)

seqirus s.r.l. - a/guangdong-maonan/swl 1536/2019 (h1n1)pdm09-like strain (a/guangdong-maonan/swl 1536/2019, cnic-1909); a/hong kong/2671/2019 (h3n2)-like strain (a/hong kong/2671/2019, ivr-208); b/washington/02/2019-like strain (b/washington/02/2019, wild type) - suspension for injection in pre-filled syringe - . - influenza vaccines; influenza, inactivated, split virus or surface antigen - influenza vaccine - prophylaxis of influenza, especially in those who run an increased risk of associated complications

Ireland - English - HPRA (Health Products Regulatory Authority)

mylan ire healthcare limited - a/victoria/2570/2019 (h1n1)pdm09 - like strain (a/victoria/2570/2019, ivr-215) ; a/cambodia/e0826360/2020 (h3n2)-like strain (a/cambodia/e0826360/2020, ivr-224); b/washington/02/2019-like strain (b/washington/02/2019, wild type) - suspension for injection in pre-filled syringe - 0.5 microgram(s) - influenza vaccines; influenza, inactivated, split virus or surface antigen

Israel - English - Ministry of Health

abbott medical laboratories ltd, israel - a/cambodia/e0826360/2020 (h3n2)-like strain; a/victoria/2570/2019 (h1n1)pdm09-like strain; b/washington/02/2019 (b/victoria lineage)-like virus - suspension for injection - b/washington/02/2019 (b/victoria lineage)-like virus 15 mcg/dose / 0.5 ml; a/cambodia/e0826360/2020 (h3n2)-like strain 15 mcg / 0.5 ml; a/victoria/2570/2019 (h1n1)pdm09-like strain 15 mcg / 0.5 ml - influenza, inactivated, split virus or surface antigen - influenza, inactivated, whole virus - influenza virus vaccine.

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

b/washington/02/2019-like strain (b/washington/02/2019, wild type) , a/victoria/2570/2019 (h1n1)pdm09-like strain (a/victoria/2570/2019, ivr-215) , a/cambodia/e0826360/2020 (h3n2)-like strain (a/cambodia/e0826360/2020, ivr-224) -

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

abbott biologicals b.v. veerweg 12 - a/guangdong-maonan/swl1536/2019 (h1n1)pdm09-like strain (a/guangdong-maonan/swl1536/2019, cnic-1909), a/hongkong/2671/2019 (h3n2)-like strain (a/hongkong/2671/2019, ivr-208), b/washington/02/2019-like strain (b/washington/02/2019, wild type) - suspension for injection - 15mcg haemagglutinin/dose+ 15mcg haemagglutinin/dose+ 15mcg haemagglutinin/dose

Canada - English - Health Canada

duchesnay inc - beta-carotene; vitamin e (dl-alpha tocopheryl acetate); ascorbic acid (ascorbic acid); vitamin b1 (thiamine mononitrate); vitamin b2 (riboflavin); nicotinamide; vitamin b6 (pyridoxine hydrochloride); d-pantothenic acid (calcium d-pantothenate); magnesium (magnesium oxide); iodine (potassium iodide); iron (ferrous fumarate); copper (cupric oxide); zinc (zinc oxide); folic acid; vitamin b12 (cyanocobalamin); vitamin d3 (cholecalciferol); calcium (calcium carbonate) - tablet - 1.6mg; 13.8mg; 120mg; 3mg; 3.4mg; 20mg; 10mg; 5mg; 50mg; 0.15mg; 35mg; 2mg; 15mg; 1.1mg; 12mcg; 250unit; 300mg - beta-carotene 1.6mg; vitamin e (dl-alpha tocopheryl acetate) 13.8mg; ascorbic acid (ascorbic acid) 120mg; vitamin b1 (thiamine mononitrate) 3mg; vitamin b2 (riboflavin) 3.4mg; nicotinamide 20mg; vitamin b6 (pyridoxine hydrochloride) 10mg; d-pantothenic acid (calcium d-pantothenate) 5mg; magnesium (magnesium oxide) 50mg; iodine (potassium iodide) 0.15mg; iron (ferrous fumarate) 35mg; copper (cupric oxide) 2mg; zinc (zinc oxide) 15mg; folic acid 1.1mg; vitamin b12 (cyanocobalamin) 12mcg; vitamin d3 (cholecalciferol) 250unit; calcium (calcium carbonate) 300mg - vitamins & minerals

Canada - English - Health Canada

duchesnay inc - folic acid; vitamin e (dl-alpha tocopheryl acetate); ascorbic acid (ascorbic acid); vitamin b1 (thiamine mononitrate); vitamin b2 (riboflavin); nicotinamide; vitamin b6 (pyridoxine hydrochloride); d-pantothenic acid (calcium d-pantothenate); magnesium (magnesium oxide); iodine (potassium iodide); iron (ferrous fumarate); copper (cupric oxide); zinc (zinc oxide); vitamin b12 (cyanocobalamin); vitamin d3 (cholecalciferol); calcium (calcium carbonate); beta-carotene - tablet - 5mg; 13.8mg; 120mg; 3mg; 3.4mg; 20mg; 10mg; 5mg; 50mg; 0.15mg; 35mg; 2mg; 15mg; 12mcg; 250unit; 300mg; 1.6mg - folic acid 5mg; vitamin e (dl-alpha tocopheryl acetate) 13.8mg; ascorbic acid (ascorbic acid) 120mg; vitamin b1 (thiamine mononitrate) 3mg; vitamin b2 (riboflavin) 3.4mg; nicotinamide 20mg; vitamin b6 (pyridoxine hydrochloride) 10mg; d-pantothenic acid (calcium d-pantothenate) 5mg; magnesium (magnesium oxide) 50mg; iodine (potassium iodide) 0.15mg; iron (ferrous fumarate) 35mg; copper (cupric oxide) 2mg; zinc (zinc oxide) 15mg; vitamin b12 (cyanocobalamin) 12mcg; vitamin d3 (cholecalciferol) 250unit; calcium (calcium carbonate) 300mg; beta-carotene 1.6mg - vitamins & minerals

Canada - English - Health Canada

duchesnay inc - beta-carotene; vitamin e (dl-alpha tocopheryl acetate); ascorbic acid (ascorbic acid); vitamin b1 (thiamine mononitrate); vitamin b2 (riboflavin); nicotinamide; vitamin b6 (pyridoxine hydrochloride); d-pantothenic acid (calcium d-pantothenate); magnesium (magnesium oxide); iodine (potassium iodide); iron (ferrous fumarate); copper (cupric oxide); zinc (zinc oxide); folic acid; vitamin b12 (cyanocobalamin); vitamin d3 (cholecalciferol); calcium (calcium carbonate) - tablet - 1.6mg; 13.8mg; 120mg; 3mg; 3.4mg; 20mg; 10mg; 5mg; 50mg; 0.15mg; 35mg; 2mg; 15mg; 1.1mg; 12mcg; 600unit; 300mg - beta-carotene 1.6mg; vitamin e (dl-alpha tocopheryl acetate) 13.8mg; ascorbic acid (ascorbic acid) 120mg; vitamin b1 (thiamine mononitrate) 3mg; vitamin b2 (riboflavin) 3.4mg; nicotinamide 20mg; vitamin b6 (pyridoxine hydrochloride) 10mg; d-pantothenic acid (calcium d-pantothenate) 5mg; magnesium (magnesium oxide) 50mg; iodine (potassium iodide) 0.15mg; iron (ferrous fumarate) 35mg; copper (cupric oxide) 2mg; zinc (zinc oxide) 15mg; folic acid 1.1mg; vitamin b12 (cyanocobalamin) 12mcg; vitamin d3 (cholecalciferol) 600unit; calcium (calcium carbonate) 300mg - vitamins & minerals