Австралия - английски - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - allopurinol, quantity: 300 mg - tablet - excipient ingredients: maize starch; magnesium stearate; povidone; sodium starch glycollate; maltodextrin; microcrystalline cellulose - indications as at 11 may 2001: main clinical manifestations of urate/uric acid deposition. these are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. such clinical manifestations may occur in idiopathic gout, uric acid lithiasis, acute uric acid nephropathy, neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy, certain enzyme disorders which lead to overproduction of urate and involve hypoxanthine guanine phosphoribosyltransferase including lesch-nyhan syndrome, glucose-6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. progout is indicated for the management of 2,8-dihydroxyadenine (2,8-dha) renal stones related to deficient activity of adenine phosphoribosyltransferase. progout is indicated for the management of recurrent mixed calcium oxalate renal stones in the p

Нова Зеландия - английски - Medsafe (Medicines Safety Authority)

amgen new zealand limited - filgrastim 300 µg/ml;   - solution for injection - 300 mcg/ml - active: filgrastim 300 µg/ml   excipient: glacial acetic acid polysorbate 80 sodium hydroxide sorbitol water for injection - neupogen is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia and its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of neupogen are similar in adults and children receiving cytotoxic chemotherapy. neupogen is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 x 10^9/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections, when other options to manage neutropenia are inappropriate.

Сингапур - английски - HSA (Health Sciences Authority)

gilead sciences singapore pte. ltd. - tenofovir disoproxil 245mg eqv tenofovir disoproxil fumarate - tablet, film coated - 300mg/ tablet - tenofovir disoproxil 245mg eqv tenofovir disoproxil fumarate 300 mg

Австралия - английски - APVMA (Australian Pesticides and Veterinary Medicines Authority)

basf australia ltd. - metazachlor - suspension concentrate - metazachlor active 500.0 g/l - herbicide

Ирландия - английски - HPRA (Health Products Regulatory Authority)

vetpharma animal health, s.l. - florfenicol - solution for injection - 300 milligram(s)/millilitre - florfenicol - cattle, pigs - antibacterial

Ирландия - английски - HPRA (Health Products Regulatory Authority)

intervet ireland limited - florfenicol - solution for injection - 300 milligram(s)/millilitre - florfenicol - pigs - antibacterial

Ирландия - английски - HPRA (Health Products Regulatory Authority)

emdoka - tilmicosin - solution for injection - 300 milligram(s)/millilitre - tilmicosin - cattle, sheep - antibacterial

Австралия - английски - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - quetiapine fumarate, quantity: 345.36 mg (equivalent: quetiapine, qty 300 mg) - tablet, film coated - excipient ingredients: magnesium stearate; calcium hydrogen phosphate dihydrate; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; hypromellose; titanium dioxide; macrogol 400; povidone - bipolar disorder, adults maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes, treatment of depressive episodes associated with bipolar disorder (see dosage and administration), treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate, children/adolescents aged 10 to 17 years, monotherapy treatment of acute mania associated with bipolar i disorder, schizophrenia (adults and adolescents aged 13 to 17 years), treatment of schizophrenia

Австралия - английски - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - quetiapine fumarate, quantity: 345.36 mg (equivalent: quetiapine, qty 300 mg) - tablet, film coated - excipient ingredients: magnesium stearate; calcium hydrogen phosphate dihydrate; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; hypromellose; titanium dioxide; macrogol 400; povidone - bipolar disorder, adults maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes, treatment of depressive episodes associated with bipolar disorder (see dosage and administration), treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate, children/adolescents aged 10 to 17 years, monotherapy treatment of acute mania associated with bipolar i disorder, schizophrenia (adults and adolescents aged 13 to 17 years), treatment of schizophrenia

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

rivopharm (uk) ltd - gabapentin - oral capsule - 300mg