Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

viatris limited - atazanavir sulfate 170.85mg equivalent to atazanavir 150mg; atazanavir sulfate 170.85mg equivalent to atazanavir 150mg - capsule - 150 mg - active: atazanavir sulfate 170.85mg equivalent to atazanavir 150mg excipient: crospovidone gelatin   iron oxide red lactose monohydrate magnesium stearate patent blue v   purified water   tekprint black sw-9008 titanium dioxide   active: atazanavir sulfate 170.85mg equivalent to atazanavir 150mg excipient: brilliant blue fcf   crospovidone erythrosine gelatin iron oxide yellow lactose monohydrate magnesium stearate purified water   titanium dioxide   - atazanavir viatris is indicated for the treatment of hiv 1 infection, in combination with other antiretroviral agents, in adult patients and in paediatric patients 6 to 18 years of age. this indication is based on analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled studies.

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

pfizer australia pty ltd - rifabutin, quantity: 150 mg - capsule, hard - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; magnesium stearate; silicon dioxide; iron oxide red; titanium dioxide; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; shellac; sulfuric acid; povidone; tert-butyl alcohol; sodium hydroxide - mycobutin is indicated for: the prophylaxis of m.avium-intracellulare complex (mac) infections in patients with advanced hiv infection (cd4 counts lower than 200/ul); the treatment of infections caused by mac and other atypical mycobacteria, including in immunocompromised patients; the treatment of chronic multi-drug resistant pulmonary tuberculosis in the presence of rifampicin resistant, rifabutin-sensitive m.tuberculosis strains; the treatment of newly diagnosed pulmonary tuberculosis in the presence of rifampicin resistant, rifabutin sensitive m.tuberculosis strains. in accordance with the commonly accepted criteria for the treatment of mycobacterial infections, mycobutin should always be given in combination with other anti-mycobacterial drugs not belonging to the family of rifamycins.

Malezja - angielski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

a. menarini singapore pte. ltd. - avanafil -

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

pierre fabre australia pty ltd - encorafenib, quantity: 50 mg - capsule, hard - excipient ingredients: magnesium stearate; copovidone; iron oxide black; gelatin; iron oxide red; iron oxide yellow; poloxamer; titanium dioxide; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; succinic acid - melanoma,encorafenib, in combination with binimetinib, is indicated for the treatment of adult patients who have unresectable or metastatic melanoma with a braf v600e or v600k mutation, as detected by a validated test.,colorectal cancer,encorafenib, in combination with cetuximab, is indicated for the treatment of adult patients who have metastatic colorectal cancer (mcrc) with a braf v600e mutation as detected by a validated test, and who have received prior systemic therapy.

Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

viiv healthcare uk ltd - fosamprenavir calcium - tablet - 700mg

Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol-myers squibb pharmaceuticals ltd - efavirenz - capsule - 50mg

Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

sanofi - rifampicin; isoniazid - oral tablet - 150mg ; 100mg

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

juno pharmaceuticals pty ltd - phenytoin sodium, quantity: 250 mg - injection, solution - excipient ingredients: sodium hydroxide; water for injections; ethanol; propylene glycol - control of status epilepticus, tonic-clonic (grand mal), psychomotor seizures and the prevention of seizures occuring during or following neurosurgery. phenytoin will prevent or effectively decrease the incidence and severity of convulvsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. besides its effectiveness in controlling seizures, phenytoin frequently improves the mental condition and outlook of epileptic patients. it has also been used in the treatment of certain cardiac arrhythmias, particularly in those patients who do not respond to convential antiarrhythmic agents or to cardioversion. phenytoin serum level determinations may be necessary for optimal dosage adjustments (see dosage and administation).

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

abbvie limited - lopinavir 200mg; ritonavir 50mg ((pharmacokinetic enhancer)) - film coated tablet - 200mg/50mg. - active: lopinavir 200mg ritonavir 50mg ((pharmacokinetic enhancer)) excipient: colloidal silicon dioxide   hyprolose hypromellose copovidone, k value 28 iron oxide yellow macrogol 3350 macrogol 400 polysorbate 80 purified talc sodium stearyl fumarate sorbitan laurate titanium dioxide - kaletra is indicated for the treatment of hiv-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older.

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - darunavir ethanolate 162.52mg equivalent to darunavir 150 mg - film coated tablet - 150 mg - active: darunavir ethanolate 162.52mg equivalent to darunavir 150 mg excipient: colloidal silicon dioxide crospovidone magnesium stearate opadry white 85f18422 purified water silicified microcrystalline cellulose - 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.