South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

curanto pharma (pty) ltd - injection - not indicated - none

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)

janssen-cilag pty ltd - ad26.cov2.s, quantity: 50000000000 vp - injection, suspension - excipient ingredients: sodium chloride; polysorbate 80; sodium hydroxide; hydroxypropylbetadex; citric acid monohydrate; sodium citrate dihydrate; ethanol absolute; hydrochloric acid; water for injections - covid-19 vaccine janssen has provisional approval for the indication:,covid-19 vaccine janssen is indicated for active immunisation to prevent 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 efficacy and safety data. continued approval is dependent upon the evidence of longer-term efficacy 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.

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

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

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - tozinameran 0.1 mg/ml equivalent to 3 µg/0.2ml dose after dilution;  ;  ;  ;   - concentrate for injection - 0.1 mg/ml - active: tozinameran 0.1 mg/ml equivalent to 3 µg/0.2ml dose after dilution         excipient: 1,2-distearoyl-sn-glycero-3-phosphocholine alc-0159 alc-0315 cholesterol sucrose trometamol trometamol hydrochloride water for injection - active immunisation to prevent coronavirus disease 2019 (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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - riltozinameran 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: riltozinameran 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 has provisional consent for the indication below: 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.

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.

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.