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.

Singapore - English - HSA (Health Sciences Authority)

biontech pharmaceuticals asia pacific pte. ltd. - famtozinameran; tozinameran - injection - famtozinameran 15 μg/dose; tozinameran 15 μg/dose

Singapore - English - HSA (Health Sciences Authority)

biontech pharmaceuticals asia pacific pte. ltd. - famtozinameran; tozinameran - injection - famtozinameran 15 μg/dose; tozinameran 15 μg/dose

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pfizer (malaysia) sdn. bhd. - famtozinameran; tozinameran -

Canada - English - Health Canada

biontech manufacturing gmbh - tozinameran; famtozinameran - suspension - 15mcg; 15mcg - tozinameran 15mcg; famtozinameran 15mcg

Canada - English - Health Canada

biontech manufacturing gmbh - tozinameran; famtozinameran - suspension - 5mcg; 5mcg - tozinameran 5mcg; famtozinameran 5mcg

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

pfizer australia pty ltd - tozinameran, quantity: 65 microgram; famtozinameran, quantity: 65 microgram - injection, concentrated - excipient ingredients: cholesterol; sucrose; water for injections; ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate); 2-((polyethylene glycol)-2000)-n-n-ditetradecylacetamide; distearoylphosphatidylcholine; trometamol; trometamol hydrochloride - 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 individuals 5 years of age to less than 12 years of age. 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 individuals 12 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: 17 microgram/ml; famtozinameran, quantity: 17 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 individuals 5 years of age to less than 12 years of age. 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: 17 microgram/ml; famtozinameran, quantity: 17 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 individuals 5 years of age to less than 12 years of age. 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.