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

lennon -

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

sad-otc -

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

gulf -

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

ranbaxy -

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

janssen-cilag pty ltd - epoetin alfa -

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

novartis pharmaceuticals australia pty ltd - epoetin lambda -

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

novartis pharmaceuticals australia pty ltd - lumefantrine; artemether -

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - epoetin alfa 16.8 µg/ml - solution for injection - 16.8 mcg/ml - active: epoetin alfa 16.8 µg/ml excipient: dibasic sodium phosphate dihydrate glycine hydrochloric acid monobasic sodium phosphate dihydrate nitrogen polysorbate 80 sodium chloride sodium hydroxide water for injection - binocrit is indicated for: · the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients with renal insufficiency not yet undergoing dialysis · anaemia associated with chronic renal failure in paediatric and adult patients on dialysis · anaemia in patients with non-myeloid malignancies where anaemia is due to the effect of concomitantly administered chemotherapy · adult patients with mild-to-moderate anaemia (haemoglobin > 100 to < 130 g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery · to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients undergoing major surgery who are not expected to pre-deposit their complete peri-operative blood needs.

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - epoetin alfa 336 µg/ml - solution for injection - 336 mcg/ml - active: epoetin alfa 336 µg/ml excipient: dibasic sodium phosphate dihydrate glycine hydrochloric acid monobasic sodium phosphate dihydrate nitrogen polysorbate 80 sodium chloride sodium hydroxide water for injection - binocrit is indicated for: · the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients with renal insufficiency not yet undergoing dialysis · anaemia associated with chronic renal failure in paediatric and adult patients on dialysis · anaemia in patients with non-myeloid malignancies where anaemia is due to the effect of concomitantly administered chemotherapy · adult patients with mild-to-moderate anaemia (haemoglobin > 100 to < 130 g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery · to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients undergoing major surgery who are not expected to pre-deposit their complete peri-operative blood needs.

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - epoetin alfa 84 µg/ml - solution for injection - 84 mcg/ml - active: epoetin alfa 84 µg/ml excipient: dibasic sodium phosphate dihydrate glycine hydrochloric acid monobasic sodium phosphate dihydrate nitrogen polysorbate 80 sodium chloride sodium hydroxide water for injection - binocrit is indicated for: · the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients with renal insufficiency not yet undergoing dialysis · anaemia associated with chronic renal failure in paediatric and adult patients on dialysis · anaemia in patients with non-myeloid malignancies where anaemia is due to the effect of concomitantly administered chemotherapy · adult patients with mild-to-moderate anaemia (haemoglobin > 100 to < 130 g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery · to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients undergoing major surgery who are not expected to pre-deposit their complete peri-operative blood needs.