Singapore - English - HSA (Health Sciences Authority)

biontech pharmaceuticals asia pacific pte. ltd. - raxtozinameran - injection - raxtozinameran 30 μg/dose

Singapore - English - HSA (Health Sciences Authority)

biontech pharmaceuticals asia pacific pte. ltd. - raxtozinameran - injection - raxtozinameran 3 µg/dose

Singapore - English - HSA (Health Sciences Authority)

biontech pharmaceuticals asia pacific pte. ltd. - famtozinameran; tozinameran - injection - famtozinameran 15 μg/dose; tozinameran 15 μg/dose

Singapore - English - HSA (Health Sciences Authority)

biontech pharmaceuticals asia pacific pte. ltd. - famtozinameran; tozinameran - injection - famtozinameran 15 μg/dose; tozinameran 15 μg/dose

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

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

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

pfizer (malaysia) sdn. bhd. - tozinameran -

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

pfizer (malaysia) sdn. bhd. - tozinameran -

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.

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.

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

pfizer australia pty ltd - tozinameran, quantity: 65 microgram; famtozinameran, quantity: 65 microgram - injection, concentrated - excipient ingredients: cholesterol; sucrose; water for injections; ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate); 2-((polyethylene glycol)-2000)-n-n-ditetradecylacetamide; distearoylphosphatidylcholine; trometamol; trometamol hydrochloride - comirnaty original/omicron ba.4-5 vaccine has provisional approval for the indication below: active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2, in individuals 5 years of age to less than 12 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 immunogenicity and safety data. continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.