Ireland - English - HPRA (Health Products Regulatory Authority)

reckitt benckiser ireland ltd - flurbiprofen - oromucosal spray, solution - 8.75 milligram(s)/dose - other throat preparations; flurbiprofen

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

activo health (pty) ltd - tablet - see ingredients - each tablet contains omeprazole 20,0 mg

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

arrotex pharmaceuticals pty ltd - varenicline tartrate, quantity: 1.71 mg (equivalent: varenicline, qty 1 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; hypromellose; triacetin; hyprolose; titanium dioxide; indigo carmine aluminium lake; sodium stearylfumarate; croscarmellose sodium - varenicline tablets are indicated as an aid to smoking cessation in adults over the age of 18 years.

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

dr reddys laboratories australia pty ltd - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: hyprolose; triacetin; titanium dioxide; microcrystalline cellulose; hypromellose acetate succinate; macrogol 400; croscarmellose sodium; purified talc; iron oxide red; magnesium stearate; silicon dioxide; hypromellose - posaconazole arx (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older: ,? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. ,? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. ,posaconazole arx is also indicated for the: ,? prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

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

dr reddys laboratories australia pty ltd - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: croscarmellose sodium; macrogol 400; hypromellose acetate succinate; silicon dioxide; triacetin; purified talc; hyprolose; iron oxide red; magnesium stearate; titanium dioxide; microcrystalline cellulose; hypromellose - posaconazole dr.reddy's (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older: ,? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. ,? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. ,posaconazole dr.reddy's is also indicated for the: ,? prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

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

cipla australia pty ltd - emtricitabine, quantity: 200 mg; tenofovir disoproxil fumarate, quantity: 300 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; pregelatinised starch; croscarmellose sodium; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake - treatment of hiv-1 infection: cipla tenofovir + emtricitabine 300/200 is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents. pre-exposure prophylaxis: cipla tenofovir + emtricitabine 300/200 is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in adults at high risk. this indication is based on clinical trials in men who have sex with men (msm) at high risk for hiv-1 infection and in heterosexual serodiscordant couples.

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

besins healthcare australia pty ltd - drospirenone, quantity: 4 mg - tablet, film coated - excipient ingredients: lactose monohydrate; maize starch; povidone; colloidal anhydrous silica; magnesium stearate; hypromellose; triacetin; polysorbate 80; titanium dioxide; indigo carmine aluminium lake; iron oxide yellow - contraception

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

arrotex pharmaceuticals pty ltd - varenicline tartrate, quantity: 1.71 mg (equivalent: varenicline, qty 1 mg) - tablet, film coated - excipient ingredients: hyprolose; titanium dioxide; hypromellose; triacetin; calcium hydrogen phosphate; indigo carmine aluminium lake; croscarmellose sodium; sodium stearylfumarate - varenicline tablets are indicated as an aid to smoking cessation in adults over the age of 18 years.

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

arrotex pharmaceuticals pty ltd - varenicline tartrate, quantity: 1.71 mg (equivalent: varenicline, qty 1 mg) - tablet, film coated - excipient ingredients: hyprolose; titanium dioxide; hypromellose; triacetin; calcium hydrogen phosphate; indigo carmine aluminium lake; croscarmellose sodium; sodium stearylfumarate - varenicline tablets are indicated as an aid to smoking cessation in adults over the age of 18 years.

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

servier laboratories (aust) pty ltd - ivosidenib, quantity: 250 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake; hypromellose acetate succinate; lactose monohydrate - cholangiocarcinoma,tibsovo is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (idh1) r132 mutation after at least one prior line of systemic therapy.,acute myeloid leukaemia,tibsovo is indicated for the treatment of acute myeloid leukaemia (aml) that carries an idh1 r132 mutation:,? as monotherapy, or in combination with azacitidine, in newly diagnosed patients who are not eligible to receive intensive induction chemotherapy; or,? as monotherapy in patients whose aml is relapsed and/or refractory to prior therapy.