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)

janssen-cilag pty ltd - darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; silicon dioxide; magnesium stearate; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - prezcobix, a fixed dose combination of darunavir and cobicistat, is indicated in combination with other antiretroviral agents for the treatment of adult patients with human immunodeficiency virus- 1 (hiv-1) infection in:,- antiretroviral treatment-naive patients,- antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma hiv-1 rna <100,000 copies/ml,- antiretroviral treatment-experienced but hiv protease inhibitor-naive patients for whom hiv-1 genotype testing is unavailable (see section 4.2 dose and method of administration)

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

janssen-cilag pty ltd - darunavir, quantity: 800 mg - tablet, film coated - excipient ingredients: magnesium stearate; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - adult patients,prezista ( with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents, for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,prezista (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

janssen-cilag pty ltd - darunavir -

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

janssen-cilag pty ltd - darunavir, quantity: 600 mg - tablet, film coated - excipient ingredients: magnesium stearate; purified talc; polyvinyl alcohol; macrogol 3350; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; sunset yellow fcf aluminium lake; titanium dioxide - adult patients,prezista ( with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents, for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,prezista (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

janssen-cilag pty ltd - topiramate, quantity: 50 mg - capsule, hard - excipient ingredients: povidone; cellulose acetate; maize starch; sucrose; titanium dioxide; sorbitan monolaurate; potable water; gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; shellac glaze-45% (20% esterified) in ethanol - epilepsy topamax is indicated in adults and children, 2 years and over: as monotherapy in patients with newly diagnosed epilepsy; for conversion to monotherapy in patients with epilepsy; as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome; migraine topamax is indicated for the prophylaxis of migraine headache in adults. the usefulness of topamax in the acute treatment of migraine headache has not been studied.

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

janssen-cilag pty ltd - topiramate, quantity: 25 mg - capsule, hard - excipient ingredients: cellulose acetate; povidone; titanium dioxide; sorbitan monolaurate; potable water; gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; shellac glaze-45% (20% esterified) in ethanol; maize starch; sucrose - epilepsy topamax is indicated in adults and children, 2 years and over: as monotherapy in patients with newly diagnosed epilepsy; for conversion to monotherapy in patients with epilepsy; as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome; migraine topamax is indicated for the prophylaxis of migraine headache in adults. the usefulness of topamax in the acute treatment of migraine headache has not been studied.

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

janssen-cilag pty ltd - topiramate, quantity: 15 mg - capsule, hard - excipient ingredients: cellulose acetate; povidone; titanium dioxide; sorbitan monolaurate; potable water; gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; shellac glaze-45% (20% esterified) in ethanol; maize starch; sucrose - epilepsy topamax is indicated in adults and children, 2 years and over: as monotherapy in patients with newly diagnosed epilepsy; for conversion to monotherapy in patients with epilepsy; as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome; migraine topamax is indicated for the prophylaxis of migraine headache in adults. the usefulness of topamax in the acute treatment of migraine headache has not been studied.

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

janssen-cilag pty ltd - topiramate, quantity: 200 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; pregelatinised maize starch; carnauba wax; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400 - epilepsy topamax is indicated in adults and children, 2 years and over: as monotherapy in patients with newly diagnosed epilepsy; for conversion to monotherapy in patients with epilepsy; as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome; migraine topamax is indicated for the prophylaxis of migraine headache in adults. the usefulness of topamax in the acute treatment of migraine headache has not been studied.

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

janssen-cilag pty ltd - topiramate, quantity: 100 mg - tablet, film coated - excipient ingredients: lactose monohydrate; pregelatinised maize starch; carnauba wax; magnesium stearate; sodium starch glycollate; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; macrogol 400 - epilepsy topamax is indicated in adults and children, 2 years and over: as monotherapy in patients with newly diagnosed epilepsy; for conversion to monotherapy in patients with epilepsy; as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome; migraine topamax is indicated for the prophylaxis of migraine headache in adults. the usefulness of topamax in the acute treatment of migraine headache has not been studied.