남아프리카 - 영어 - South African Health Products Regulatory Authority (SAHPRA)

sanofi-aventis south africa (pty) ltd - tablet - see ingredients - each tablet contains rifapentine 150,0 mg

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

otsuka australia pharmaceutical pty ltd - tolvaptan, quantity: 15 mg - tablet - excipient ingredients: hyprolose; magnesium stearate; microcrystalline cellulose; indigo carmine aluminium lake; lactose monohydrate; maize starch - samsca is indicated for the treatment of clinically significant hypervolemic or euvolemic hyponatremia (serum sodium less than 125 mmol/l, or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) including patients with heart failure and syndrome of inappropriate antidiuretic hormone (siadh).

탄자니아 - 영어 - Tanzania Medicinces & Medical Devices Authority

mylan laboratories limited, india - dolutegravir sodium - tablets - 50/200/25 mg

남아프리카 - 영어 - South African Health Products Regulatory Authority (SAHPRA)

macleods pharmaceuticals sa (pty) ltd - tablet - see ingredients - each tablet contains isoniazid 300,0 mgrifapentine 300,0 mg

남아프리카 - 영어 - South African Health Products Regulatory Authority (SAHPRA)

macleods pharmaceuticals sa (pty) ltd - tablet - see ingredients - each tablet contains isoniazid 300,0 mg rifapentine 300,0 mg

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

accelagen pty ltd - erlotinib hydrochloride, quantity: 109.267 mg (equivalent: erlotinib, qty 100 mg) - tablet, film coated - excipient ingredients: titanium dioxide; magnesium stearate; hyprolose; lactose monohydrate; microcrystalline cellulose; hypromellose; sodium lauryl sulfate; sodium starch glycollate - non-small cell lung cancer,erlotinib arx 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.,erlotinib arx 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.,erlotinib arx 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,erlotinib arx in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

accelagen pty ltd - erlotinib hydrochloride, quantity: 163.9 mg (equivalent: erlotinib, qty 150 mg) - tablet, film coated - excipient ingredients: titanium dioxide; sodium starch glycollate; lactose monohydrate; magnesium stearate; hyprolose; propylene glycol; microcrystalline cellulose; hypromellose; sodium lauryl sulfate - non-small cell lung cancer,erlotinib arx 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.,erlotinib arx 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.,erlotinib arx 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,erlotinib arx in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

accelagen pty ltd - erlotinib hydrochloride, quantity: 27.317 mg (equivalent: erlotinib, qty 25 mg) - tablet, film coated - excipient ingredients: propylene glycol; magnesium stearate; lactose monohydrate; sodium lauryl sulfate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; hypromellose; hyprolose - non-small cell lung cancer,erlotinib arx 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.,erlotinib arx 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.,erlotinib arx 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,erlotinib arx in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - erlotinib hydrochloride, quantity: 109.27 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; sodium starch glycollate type a; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer - non-small cell lung cancer erlotinib sandoz 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.,erlotinib sandoz is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfrmutations who have not progressed on first-line chemotherapy.,erlotinib sandoz 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 erlotinib sandoz in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - erlotinib hydrochloride, quantity: 27.32 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; sodium starch glycollate type a; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer - non-small cell lung cancer erlotinib sandoz 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.,erlotinib sandoz is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfrmutations who have not progressed on first-line chemotherapy.,erlotinib sandoz 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 erlotinib sandoz in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.