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.

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

origins natural resources inc. - octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51), octisalate (unii: 4x49y0596w) (octisalate - unii:4x49y0596w), avobenzone (unii: g63qqf2nox) (avobenzone - unii:g63qqf2nox) - octinoxate 7.5 ml in 100 ml - - helps prevent sunburn - if used as directed with other sun protection measures (see directions, ) decreases the risk of skin cancer and early skin aging caused by the sun.

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

origins natural resources inc. - octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51), octisalate (unii: 4x49y0596w) (octisalate - unii:4x49y0596w), octocrylene (unii: 5a68wgf6wm) (octocrylene - unii:5a68wgf6wm), titanium dioxide (unii: 15fix9v2jp) (titanium dioxide - unii:15fix9v2jp), zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) - - helps prevent sunburn - if used as directed with other sun protection measures (see directions ) decreases the risk of skin cancer and early skin aging caused by the sun

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

nature republic co., ltd. - titanium dioxide (unii: 15fix9v2jp) (titanium dioxide - unii:15fix9v2jp), octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51), zinc oxide (unii: soi2loh54z) (zinc cation - unii:13s1s8sf37) - titanium dioxide 2.87 g in 45 g - purpose: [uv protection] this bb cream with the active ingredient of a plant-based collagen makes the skin firm and supple. how to use: after completing your basic skincare routine, apply a small amount of the cream to your face using gentle strokes to produce a fresh and natural skin tone.

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - famtozinameran 0.05 mg/ml equivalent to 15µg/0.3ml dose;  ;  ;  ;  ; tozinameran 0.05 mg/ml equivalent to 15µg/0.3ml dose;  ;  ;  ;   - suspension for injection - 0.1 mg/ml - active: famtozinameran 0.05 mg/ml equivalent to 15µg/0.3ml dose         tozinameran 0.05 mg/ml equivalent to 15µg/0.3ml dose         excipient: 1,2-distearoyl-sn-glycero-3-phosphocholine alc-0159 alc-0315 cholesterol sucrose trometamol trometamol hydrochloride water for injection - comirnaty original/omicron ba.4/ba.5 has provisional consent for the indication below: a booster dose 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. the use of this vaccine should be in accordance with official recommendations.