Bandaríkin - enska - NLM (National Library of Medicine)

cargus international, inc. - benzocaine (unii: u3rsy48jw5) (benzocaine - unii:u3rsy48jw5) - oral anesthetic for the temporary relief of pain associated with canker sores and minor dental procedures.

Ástralía - enska - 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.

Malasía - enska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

apex pharmacy marketing sdn. bhd. - atorvastatin calcium -

Malasía - enska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

apex pharmacy marketing sdn. bhd. - atorvastatin calcium -

Malasía - enska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

apex pharmacy marketing sdn. bhd. - atorvastatin calcium -

Malasía - enska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

apex pharmacy marketing sdn. bhd. - atorvastatin calcium -

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - imdevimab, quantity: 120 mg/ml - injection, solution - excipient ingredients: histidine; histidine hydrochloride monohydrate; sucrose; polysorbate 80; water for injections - ronapreve has provisional approval for the indications below:,treatment:,ronapreve is indicated for the treatment of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for covid-19 and who are at increased risk of progressing to severe covid-19.,post-exposure prophylaxis:,ronapreve is indicated for the prevention of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to sars-cov-2 and who either:,? have a medical condition making them unlikely to respond to or be protected by vaccination, or,? are not vaccinated against covid-19. (,refer to section 4.2 dose and method of administration and section 5.1, clinical trials),ronapreve is not intended to be used as a substitute for vaccination against covid-19.,the decision has been made on the basis of short term efficacy and safety data. continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.,the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. see sections 4.4 and 5.1.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - imdevimab, quantity: 120 mg/ml - injection, solution - excipient ingredients: histidine; histidine hydrochloride monohydrate; sucrose; polysorbate 80; water for injections - ronapreve has provisional approval for the indications below:,treatment:,ronapreve is indicated for the treatment of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for covid-19 and who are at increased risk of progressing to severe covid-19.,post-exposure prophylaxis:,ronapreve is indicated for the prevention of covid-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to sars-cov-2 and who either:,? have a medical condition making them unlikely to respond to or be protected by vaccination, or,? are not vaccinated against covid-19.,(refer to section 4.2 dose and method of administration and 5.1, clinical trials),ronapreve is not intended to be used as a substitute for vaccination against covid-19.,the decision has been made on the basis of short term efficacy and safety data. continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.,the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. see sections 4.4 and 5.1.

Ástralía - enska - 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.

Ástralía - enska - 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.