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

roche products pty ltd - erlotinib hydrochloride, quantity: 27.32 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; lactose monohydrate; sodium lauryl sulfate; sodium starch glycollate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - non-small cell lung cancer: tarceva is indicated for the first-line treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations. tarceva is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutations who have not progressed on first-line chemotherapy. tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. pancreatic cancer: tarceva in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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

pfizer australia pty ltd - palbociclib, quantity: 100 mg - capsule, hard - excipient ingredients: magnesium stearate; iron oxide yellow; silicon dioxide; iron oxide red; microcrystalline cellulose; sodium starch glycollate type a; lactose monohydrate; titanium dioxide; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; shellac; sulfuric acid - ibrance is indicated for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: ? an aromatase inhibitor as initial endocrine-based therapy ? fulvestrant in patients who have received prior therapy.

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

pfizer australia pty ltd - palbociclib, quantity: 75 mg - capsule, hard - excipient ingredients: silicon dioxide; iron oxide yellow; iron oxide red; titanium dioxide; magnesium stearate; sodium starch glycollate type a; gelatin; lactose monohydrate; microcrystalline cellulose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; shellac; sulfuric acid - ibrance is indicated for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: ? an aromatase inhibitor as initial endocrine-based therapy ? fulvestrant in patients who have received prior therapy.

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

pfizer australia pty ltd - palbociclib, quantity: 125 mg - capsule, hard - excipient ingredients: gelatin; sodium starch glycollate type a; iron oxide yellow; silicon dioxide; magnesium stearate; titanium dioxide; iron oxide red; lactose monohydrate; microcrystalline cellulose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; shellac; sulfuric acid - ibrance is indicated for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: ? an aromatase inhibitor as initial endocrine-based therapy ? fulvestrant in patients who have received prior therapy.

Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 400 mg - darunavir - darunavir - prezista , co-administered with 100 mg ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for over 18 years of age.

Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 600 mg - darunavir - darunavir - prezista , co-administered with 100 mg ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for over 18 years of age.

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide - hiv infections - antivirals for systemic use - treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (hiv 1) without known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (nnrti) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 hiv 1 rna copies/ml.,

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

accord-uk ltd - clarithromycin - oral tablet - 250mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

accord-uk ltd - clarithromycin - oral tablet - 500mg

Israel - English - Ministry of Health

gilead sciences israel ltd - emtricitabine; tenofovir alafenamide fumarate - film coated tablets - tenofovir alafenamide fumarate 10 mg; emtricitabine 200 mg - tenofovir disoproxil and emtricitabine - descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (hiv 1).