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.

Malta - English - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - influenza vaccine, split virion, inactivated - suspension for injection in pre-filled syringe - influenza vaccine (split virion, inactivated) 15 µg - vaccines

Malta - English - Medicines Authority

smithkline beecham limited - mumps vaccine rit 4385; measles virus - schwarz strain; rubella virus - wistar ra27/3 strain - powder and solvent for solution for injection - mumps vaccine rit 4385; measles virus - schwarz strain; rubella virus - wistar ra27/3 strain - vaccines

European Union - English - EMA (European Medicines Agency)

resilience biomanufacturing ireland limited - influenza vaccine (whole virion, inactivated) containing antigen of: a/vietnam/1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaccines - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance.

Malta - English - Medicines Authority

mylan products limited - influenza vaccine (split virion, inactivated) - suspension for injection in pre-filled syringe - influenza vaccine (split virion, inactivated) 15 µg - vaccines