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.

European Union - English - EMA (European Medicines Agency)

biontech manufacturing gmbh - single-stranded, 5’-capped messenger rna 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 - comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. comirnaty original/omicron ba.1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent 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.comirnaty original/omicron ba.4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.comirnaty original/omicron ba.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.comirnaty original/omicron ba.4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty original/omicron ba.4-5 (1.5/1.5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. comirnaty omicron xbb.1.5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.comirnaty omicron xbb.1.5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.comirnaty omicron xbb.1.5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.comirnaty omicron xbb.1.5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.the use of this vaccine should be in accordance with official recommendations.

Singapore - English - HSA (Health Sciences Authority)

moderna biotech singapore pte. ltd. - andusomeran - injection, solution - andusomeran 0.10 mg/ml

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.

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.

Israel - English - Ministry of Health

medison pharma ltd - cx-024414 mrna - dispersion for injection - cx-024414 mrna 1.26 mg/vial - covid-19 vaccines - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - covid-19 mrna vaccine - concentrate for dispersion for injection - covid-19 mrna vaccine 0.5 mg/ml - covid-19 vaccines - comirnaty is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 virus, in individuals 12 years of age and older.

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.