Australija - engleski - 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.

Australija - engleski - 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.

Australija - engleski - 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.

Australija - engleski - 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.

Australija - engleski - 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.

Južnoafrička Republika - engleski - South African Health Products Regulatory Authority (SAHPRA)

saimr -

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

te arai biofarma limited - aspirin 100mg (2 x 50mg);  ; atorvastatin calcium trihydrate 21.69mg (2 x 10.845mg (equivalent to 20mg atorvastatin));  ; ramipril 10mg;   - combination capsule - 100mg/20mg/10mg - active: aspirin 100mg (2 x 50mg)   excipient: microcrystalline cellulose opadry white oy-b-28920 amb purified talc sodium starch glycolate active: atorvastatin calcium trihydrate 21.69mg (2 x 10.845mg (equivalent to 20mg atorvastatin))   excipient: calcium carbonate colloidal silicon dioxide crospovidone hyprolose lactose monohydrate magnesium stearate opadry green 06o21881 polysorbate 80 pregelatinised maize starch active: ramipril 10mg   excipient: hypromellose microcrystalline cellulose opadry yellow sodium stearyl fumarate starch black ink (trinomia) gelatin iron oxide red titanium dioxide - trinomia is indicated for the secondary prevention of cardiovascular accidents as substitution therapy in adult patients adequately controlled with the mono-components given concomitantly at equivalent therapeutical doses

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

te arai biofarma limited - aspirin 100mg (2 x 50mg);  ; atorvastatin calcium trihydrate 21.69mg (2 x 10.845mg (equivalent to 20mg atorvastatin));  ; ramipril 2.5mg;   - combination capsule - 100mg/20mg/2.5mg - active: aspirin 100mg (2 x 50mg)   excipient: microcrystalline cellulose opadry white oy-b-28920 amb purified talc sodium starch glycolate active: atorvastatin calcium trihydrate 21.69mg (2 x 10.845mg (equivalent to 20mg atorvastatin))   excipient: calcium carbonate colloidal silicon dioxide crospovidone hyprolose lactose monohydrate magnesium stearate opadry green 06o21881 polysorbate 80 pregelatinised maize starch active: ramipril 2.5mg   excipient: hypromellose microcrystalline cellulose opadry yellow 80w32039 sodium stearyl fumarate starch black ink (trinomia) gelatin iron oxide black titanium dioxide - trinomia is indicated for the secondary prevention of cardiovascular accidents as substitution therapy in adult patients adequately controlled with the mono-components given concomitantly at equivalent therapeutical doses

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

te arai biofarma limited - aspirin 100mg (2 x 50mg);  ; atorvastatin calcium trihydrate 21.69mg (2 x 10.845mg (equivalent to 20mg atorvastatin));  ; ramipril 5mg;   - combination capsule - 100mg/20mg/5mg - active: aspirin 100mg (2 x 50mg)   excipient: microcrystalline cellulose opadry white oy-b-28920 amb purified talc sodium starch glycolate active: atorvastatin calcium trihydrate 21.69mg (2 x 10.845mg (equivalent to 20mg atorvastatin))   excipient: calcium carbonate colloidal silicon dioxide crospovidone hyprolose lactose monohydrate magnesium stearate opadry green 06o21881 polysorbate 80 pregelatinised maize starch active: ramipril 5mg   excipient: hypromellose microcrystalline cellulose opadry yellow sodium stearyl fumarate starch black ink (trinomia) gelatin iron oxide black iron oxide red titanium dioxide - trinomia is indicated for the secondary prevention of cardiovascular accidents as substitution therapy in adult patients adequately controlled with the mono-components given concomitantly at equivalent therapeutical doses

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

chiesi ltd - autologous human corneal epithelial cells - living tissue equivalent - 197500cell/1square cm