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

pfizer australia pty ltd - somatropin, quantity: 12 mg/ml - injection, powder for - excipient ingredients: glycine; mannitol; monobasic sodium phosphate; dibasic sodium phosphate - short stature due to decreased or failed secretion of pituitary growth hormone. treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml. growth disturbances associated with gonadal dysgenesis (turner's syndrome). improvement of body composition and treatment of short stature associated with prader-willi syndrome (pws) in paediatric patients. for treatment of growth disturbance in children with chronic renal insufficiency whose height is on or less than twenty-fifth percentile and whose growth velocity is on or less than twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 50 ml/min/1.73m2.

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

pfizer australia pty ltd - somatropin, quantity: 5 mg/ml - injection, powder for - excipient ingredients: glycine; mannitol; monobasic sodium phosphate; dibasic sodium phosphate - short stature due to decreased or failed secretion of pituitary growth hormone. treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml. growth disturbances associated with gonadal dysgenesis (turner's syndrome). improvement of body composition and treatment of short stature associated with prader-willi syndrome (pws) in paediatric patients. for treatment of growth disturbance in children with chronic renal insufficiency whose height is on or less than twenty-fifth percentile and whose growth velocity is on or less than twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 50 ml/min/1.73m2.

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

novartis pharmaceuticals australia pty ltd - travoprost, quantity: 40 microgram/ml - eye drops, solution - excipient ingredients: boric acid; ethoxylated hydrogenated castor oil; polyquaternium-1; sodium hydroxide; mannitol; hydrochloric acid; propylene glycol; purified water; sodium chloride - travatan eye drops are indicated to decrease elevated intraocular pressure in: - ocular hypertension. - open-angle glaucoma. travatan eye drops may be used: - as first line monotherapy. - as adjunctive therapy.

Estados Unidos - inglés - NLM (National Library of Medicine)

tianjin kingyork pharmaceuticals co., ltd - methylprednisolone sodium succinate (unii: lec9gky20k) (methylprednisolone - unii:x4w7zr7023) - when oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of methylprednisolone sodium succinate for injection, usp is indicated as follows: allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions,  serum sickness, transfusion reactions. dermatologic diseases: bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (stevens-johnson syndrome). endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. gastrointestinal diseases: to tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. hematologic disorders: acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (diamond-blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. miscellaneous: trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. neoplastic diseases: for the palliative management of leukemias and lymphomas. nervous system: acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. ophthalmic diseases: sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. renal diseases: to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. respiratory diseases: berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). for the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus. methylprednisolone sodium succinate for injection, usp sterile powder is contraindicated: - in systemic fungal infections and patients with known hypersensitivity to the product and its constituents. the methylprednisolone sodium succinate for injection, usp 40 mg presentation includes lactose monohydrate produced from cow’s milk. this presentation is therefore contraindicated in patients with a known or suspected hypersensitivity to cow’s milk or its components or other dairy products because it may contain trace amounts of milk ingredients. - for intrathecal administration. reports of severe medical events have been associated with this route of administration. intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. additional contraindication for the use of methylprednisolone sodium succinate for injection, usp sterile powder preserved with benzyl alcohol: formulations preserved with benzyl alcohol are contraindicated for use in premature infants. (see warnings and precautions, pediatric use ).

Israel - inglés - Ministry of Health

novartis israel ltd - travoprost - ophthalmic solution - travoprost 0.004 %w/v - travoprost - travoprost - for the reduction of elevated intra ocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of other iop lowering medications or insufficiently responsive to another iop lowering medication.

Irlanda - inglés - HPRA (Health Products Regulatory Authority)

primecrown 2010 ltd - tafluprost - eye drops solution - 15 microgram/ml - prostaglandin analogues

Reino Unido - inglés - MHRA (Medicines & Healthcare Products Regulatory Agency)

santen uk ltd - tafluprost - eye drops - 15microgram/1ml

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

pct holdings pty ltd - spinosad manufacturing concentrate - suspension concentrate - spinosad manufacturing concentrate ungrouped active 120.0 g/l - insecticide

Singapur - inglés - HSA (Health Sciences Authority)

abbvie pte. ltd. - clostridium botulinum toxin type a - injection, powder, for solution - 100 units/vial - clostridium botulinum toxin type a 100 units/vial

Singapur - inglés - HSA (Health Sciences Authority)

abbvie pte. ltd. - botulinum toxin type a - injection, powder, for solution - 200 units - botulinum toxin type a 200 units