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

moderna australia pty ltd - elasomeran, quantity: 0.2 mg/ml - injection, suspension - excipient ingredients: heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; trometamol hydrochloride; trometamol; water for injections; cholesterol; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; sodium acetate trihydrate; sucrose; distearoylphosphatidylcholine; glacial acetic acid - spikevax (elasomeran) covid-19 vaccine has provisional approval for the indication below:,active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 6 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 efficacy and safety data. continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment. active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 6 years of age and older. the use of this vaccine should be in accordance with official recommendations.

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

moderna australia pty ltd - elasomeran, quantity: 0.1 mg/ml - injection, suspension - excipient ingredients: cholesterol; distearoylphosphatidylcholine; trometamol; trometamol hydrochloride; glacial acetic acid; sodium acetate trihydrate; sucrose; water for injections; heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 - spikevax (elasomeran) covid-19 vaccine has provisional approval for the indication below:,active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 6 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 efficacy and safety data. continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and postmarket assessment spikevax (elasomeran) covid-19 vaccine is indicated for: active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 6 years of age and older. the use of this vaccine should be in accordance with official recommendations.

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

moderna australia pty ltd - elasomeran, quantity: 0.1 mg/ml - injection, suspension - excipient ingredients: heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; cholesterol; distearoylphosphatidylcholine; trometamol; trometamol hydrochloride; glacial acetic acid; sodium acetate trihydrate; sucrose; water for injections; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 - spikevax (elasomeran) covid-19 vaccine has provisional approval for the indication below:active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 6 months of age to <6 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 efficacy and safety data. continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment. spikevax (elasomeran) covid-19 vaccine is indicated for: active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 6 years of age and older. the use of this vaccine should be in accordance with official recommendations.

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

moderna australia pty ltd - elasomeran, quantity: 0.05 mg/ml; imelasomeran, quantity: 0.05 mg/ml - injection, suspension - excipient ingredients: heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; water for injections; trometamol; sodium acetate trihydrate; sucrose; distearoylphosphatidylcholine; cholesterol; glacial acetic acid; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; trometamol hydrochloride - spikevax bivalent original/omicron (elasomeran/imelasomeran) covid-19 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 immunogenicity and short-term safety data. continued approval depends on the evidence of longer term benefits and safety from ongoing clinical trials and post-market assessment.

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

moderna australia pty ltd - elasomeran, quantity: 0.05 mg/ml; imelasomeran, quantity: 0.05 mg/ml - injection, suspension - excipient ingredients: heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; water for injections; trometamol; sodium acetate trihydrate; sucrose; distearoylphosphatidylcholine; cholesterol; glacial acetic acid; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; trometamol hydrochloride - spikevax bivalent original/omicron (elasomeran/imelasomeran) covid-19 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 immunogenicity and short-term safety data. continued approval depends on the evidence of longer term benefits and safety from ongoing clinical trials and post-market assessment.

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

moderna australia pty ltd - elasomeran, quantity: 0.05 mg/ml; davesomeran, quantity: 0.05 mg/ml - injection, suspension - excipient ingredients: 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; distearoylphosphatidylcholine; heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; sucrose; trometamol; cholesterol; trometamol hydrochloride; sodium acetate trihydrate; water for injections; glacial acetic acid - spikevax bivalent original/omicron ba.4-5 (elasomeran/davesomeran) covid-19 vaccine is indicated for:,as a booster dose for active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19.,the use of this vaccine should be in accordance with official recommendations.

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

moderna australia pty ltd - davesomeran, quantity: 0.05 mg/ml; elasomeran, quantity: 0.05 mg/ml - injection, suspension - excipient ingredients: water for injections; cholesterol; glacial acetic acid; heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; trometamol; sucrose; distearoylphosphatidylcholine; sodium acetate trihydrate; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; trometamol hydrochloride - spikevax bivalent original/omicron ba.4-5 (elasomeran/davesomeran) covid-19 vaccine is indicated for:,as a booster dose for active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19.,the use of this vaccine should be in accordance with official recommendations.

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

moderna australia pty ltd - elasomeran, quantity: 0.05 mg/ml; davesomeran, quantity: 0.05 mg/ml - injection, suspension - excipient ingredients: 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; distearoylphosphatidylcholine; heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; sucrose; trometamol; cholesterol; trometamol hydrochloride; sodium acetate trihydrate; water for injections; glacial acetic acid - spikevax bivalent original/omicron ba.4-5 (elasomeran/davesomeran) covid-19 vaccine is indicated for:,as a booster dose for active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19.,the use of this vaccine should be in accordance with official recommendations.

European Union - English - EMA (European Medicines Agency)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - vaccines - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.spikevax bivalent original/omicron ba.1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19.spikevax bivalent original/omicron ba.4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax xbb.1.5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older.the use of this vaccine should be in accordance with official recommendations.

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

moderna us, inc. - elasomeran (unii: epk39pl4r4) (elasomeran - unii:epk39pl4r4) - spikevax is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 18 years of age and older. do not administer spikevax to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of spikevax [see description (11)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to spikevax during pregnancy. women who are vaccinated with spikevax during pregnancy are encouraged to enroll in the registry by calling 1-866-moderna (1-866-663-3762). 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 on spikevax administered to pregnant women are insufficient to inform