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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj), bnt162b2 omicron (ba.4/ba.5) (unii: jsv288q5cv) (bnt162b2 omicron (ba.4/ba.5) - unii:jsv288q5cv) -

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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj), famtozinameran (unii: jsv288q5cv) (famtozinameran - unii:jsv288q5cv) - pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 12 years of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5), hereafter referred to as pfizer-biontech covid-19 vaccine, bivalent. do not administer pfizer-biontech covid-19 vaccine, bivalent to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine or the pfizer-biontech covid-19 vaccine, bivalent [see description (13)] . risk summary no data are available regarding the use of pfizer-biontech covid-19 vaccine, bivalent during pregnancy. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, t

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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj), famtozinameran (unii: jsv288q5cv) (famtozinameran - unii:jsv288q5cv) - pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 5 years of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5), hereafter referred to as pfizer-biontech covid-19 vaccine, bivalent, supplied in a multiple dose vial with an orange cap and a label with an orange border, which is authorized for use in individuals 5 through 11 years of age. the vial labels state: age 5y to <12y. the carton labels state: for age 5 years to <12 years. do not administer pfizer-biontech covid-19 vaccine, bivalent to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine or the pfizer-biontech covid-19 vaccine, bivalent [

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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj) - pfizer-biontech covid-19 vaccine is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 6 months of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine supplied in a multiple dose vial with a purple cap, which is authorized for use in individuals 12 years of age and older. do not administer pfizer-biontech covid-19 vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine [see description (13)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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 on pfizer-biontech covid-19 vaccine

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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj) - pfizer-biontech covid-19 vaccine and pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) are authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 6 months of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine and pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5), hereafter referred to as pfizer-biontech covid-19 vaccine, bivalent, supplied in multiple dose vials with maroon caps and labels with maroon borders, which are authorized for use in individuals 6 months through 4 years of age. do not administer pfizer-biontech covid-19 vaccine or pfizer-biontech covid-19 vaccine, bivalent to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine [see description (13)] .       p

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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj) - pfizer-biontech covid-19 vaccine is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 6 months of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine supplied in a multiple dose vial with a gray cap and label with a gray border, which is authorized for use in individuals 12 years of age and older. do not administer pfizer-biontech covid-19 vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine [see description (13)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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 on pfizer

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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj) - pfizer-biontech covid-19 vaccine is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 6 months of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine supplied in a multiple dose vial with an orange cap and a label with an orange border, which is authorized for use in individuals 5 through 11 years of age. the vial labels state: age 5y to <12y. the carton labels state: for age 5 years to <12 years. do not administer pfizer-biontech covid-19 vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine [see description (13)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage i

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

pfizer australia pty ltd - riltozinameran, quantity: 50 microgram/ml; tozinameran, quantity: 50 microgram/ml - injection, suspension - excipient ingredients: water for injections; distearoylphosphatidylcholine; trometamol; trometamol hydrochloride; sucrose; 2-((polyethylene glycol)-2000)-n-n-ditetradecylacetamide; ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate); cholesterol - comirnaty original/omicron ba.1 vaccine has provisional approval for the indication below: as a booster dose for active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2, in individuals 18 years of age and older. the use of this vaccine should be in accordance with official recommendations. the decision has been made on the basis of short term immunogenicity and safety data. continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

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

pfizer australia pty ltd - tozinameran, quantity: 50 microgram/ml; famtozinameran, quantity: 50 microgram/ml - injection, suspension - excipient ingredients: cholesterol; sucrose; distearoylphosphatidylcholine; ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate); 2-((polyethylene glycol)-2000)-n-n-ditetradecylacetamide; trometamol hydrochloride; water for injections; trometamol - comirnaty original/omicron ba.4-5 vaccine has provisional approval for the indication below:,active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov- 2, in individuals12 years of age and older.,the use of this vaccine should be in accordance with official recommendations.,the decision has been made on the basis of short term immunogenicity and safety data. continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

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

pfizer australia pty ltd - raxtozinameran, quantity: 16 microgram - injection, suspension - excipient ingredients: ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate); water for injections; cholesterol; 2-((polyethylene glycol)-2000)-n-n-ditetradecylacetamide; sucrose; distearoylphosphatidylcholine; trometamol; trometamol hydrochloride - active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2, in individuals 5 years of age to less than 12 years of age.,the use of this vaccine should be in accordance with official recommendations.