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

baxter healthcare pty ltd - mesna, quantity: 100 mg/ml - injection, solution - excipient ingredients: water for injections; nitrogen; sodium hydroxide; disodium edetate; benzyl alcohol - for the reduction and prevention of urinary tract toxicity (haemorrhagic cystitis) of oxazaphosphorines (see adverse effects sections of the cyclophosphamide and ifosfamide product information).

Australia - englanti - APVMA (Australian Pesticides and Veterinary Medicines Authority)

adama australia pty limited - clethodim; liquid hydrocarbon - emulsifiable concentrate - clethodim cyclohexanediones active 360.0 g/l; liquid hydrocarbon solvent other 534.0 g/l - herbicide

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

sanofi-aventis australia pty ltd - nilutamide -

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

baxter healthcare pty ltd - mesna, quantity: 100 mg/ml - injection, concentrated - excipient ingredients: disodium edetate; sodium hydroxide; water for injections - for the reduction and prevention of urinary tract toxicity (haemorrhagic cystitis) of oxazaphosphorines (see adverse effects section of the cyclophosphamide and ifosfamide product information).

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

baxter healthcare pty ltd - mesna, quantity: 100 mg/ml - injection, concentrated - excipient ingredients: disodium edetate; sodium hydroxide; water for injections - for the reduction and prevention of urinary tract toxicity (haemorrhagic cystitis) of oxazaphosphorines (see adverse effects section of the cyclophosphamide and ifosfamide product information).

Israel - englanti - Ministry of Health

medison pharma ltd - lomitapide as mesylate - capsules - lomitapide as mesylate 10 mg - lomitapide - an adjunct to a low-fat diet and other lipid-lowering treatments, including ldl apheresis where available, to reduce low-density lipoprotein cholesterol (ldl-c), total cholesterol (tc), apolipoprotein b (apo b), and non-high-density lipoprotein cholesterol (non-hdl-c) in patients with homozygous familial hypercholesterolemia (hofh).

Israel - englanti - Ministry of Health

medison pharma ltd - lomitapide as mesylate - capsules - lomitapide as mesylate 20 mg - lomitapide - an adjunct to a low-fat diet and other lipid-lowering treatments, including ldl apheresis where available, to reduce low-density lipoprotein cholesterol (ldl-c), total cholesterol (tc), apolipoprotein b (apo b), and non-high-density lipoprotein cholesterol (non-hdl-c) in patients with homozygous familial hypercholesterolemia (hofh).

Israel - englanti - Ministry of Health

medison pharma ltd - lomitapide as mesylate - capsules - lomitapide as mesylate 5 mg - lomitapide - an adjunct to a low-fat diet and other lipid-lowering treatments, including ldl apheresis where available, to reduce low-density lipoprotein cholesterol (ldl-c), total cholesterol (tc), apolipoprotein b (apo b), and non-high-density lipoprotein cholesterol (non-hdl-c) in patients with homozygous familial hypercholesterolemia (hofh).

Israel - englanti - Ministry of Health

rafa laboratories ltd - treprostinil as sodium - solution for injection - treprostinil as sodium 10 mg/ml - treprostinil - remodulin is indicated as a continuous subcutaneous infusion or intravenous infusion for the treatment of primary pulmonary arterial hypertension and pulmonary arterial hypertension associated with connective tissue disorders. pulmonary hypertension associated with congenital systemic to pulmonary shunts.

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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 25 mg - capsule, soft - excipient ingredients: gelatin; iron oxide black; polysorbate 20; purified water; ethyl lactate; sorbitan oleate; titanium dioxide; peg-40 hydrogenated castor oil; glycerol; tricaprin; lecithin - ciclosporin is indicated: ? as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. ? for induction and/or maintenance of remission in the nephrotic syndrome. ciclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see section 4.4 special warnings and precautions for use). ? for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. ? in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patients is mandatory. ciclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see section 4.4 special warnings and precautions for use).