האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

teva b.v. - zoledronic acid - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - drugs for treatment of bone diseases - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture including those with a recent low-trauma hip fracture. treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: , in post-menopausal women;, in men; , at increased risk of fracture. treatment of paget’s disease of the bone in adults.,

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - rasagiline mesilate, quantity: 1.56 mg (equivalent: rasagiline, qty 1 mg) - tablet - excipient ingredients: stearic acid; purified talc; mannitol; colloidal anhydrous silica; maize starch; pregelatinised maize starch - rasailine-teva is indicated for the symptomatic treatment of idiopathic parkinson?s disease (pd) as monotherapy and as adjunct therapy to dopamine agonists or to levodopa.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - methylphenidate hydrochloride, quantity: 18 mg - tablet, modified release - excipient ingredients: colloidal anhydrous silica; magnesium stearate; fumaric acid; lactose monohydrate; triethyl citrate; purified talc; methacrylic acid copolymer; hypromellose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - methylphenidate-teva xr is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme methylphenidate-teva xr is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of methylphenidate hydrochloride extended release tablets for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use methylphenidate-teva xr for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - methylphenidate hydrochloride, quantity: 27 mg - tablet, modified release - excipient ingredients: colloidal anhydrous silica; lactose monohydrate; methacrylic acid copolymer; purified talc; fumaric acid; magnesium stearate; triethyl citrate; hypromellose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; titanium dioxide; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - methylphenidate-teva xr is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme methylphenidate-teva xr is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of methylphenidate hydrochloride extended release tablets for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use methylphenidate-teva xr for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - methylphenidate hydrochloride, quantity: 36 mg - tablet, modified release - excipient ingredients: triethyl citrate; methacrylic acid copolymer; lactose monohydrate; hypromellose; colloidal anhydrous silica; purified talc; magnesium stearate; fumaric acid; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; titanium dioxide; polyvinyl alcohol; macrogol 3350 - methylphenidate-teva xr is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme methylphenidate-teva xr is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of methylphenidate hydrochloride extended release tablets for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use methylphenidate-teva xr for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - methylphenidate hydrochloride, quantity: 54 mg - tablet, modified release - excipient ingredients: purified talc; colloidal anhydrous silica; methacrylic acid copolymer; fumaric acid; magnesium stearate; lactose monohydrate; triethyl citrate; hypromellose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; titanium dioxide; iron oxide red; polyvinyl alcohol; macrogol 3350 - methylphenidate-teva xr is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme methylphenidate-teva xr is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of methylphenidate hydrochloride extended release tablets for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use methylphenidate-teva xr for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - fingolimod hydrochloride, quantity: 560 microgram (equivalent: fingolimod, qty 500 microgram) - capsule, hard - excipient ingredients: iron oxide yellow; titanium dioxide; gelatin; sodium lauryl sulfate; pregelatinised maize starch; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - fingolimod-teva is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 9.075 mg - capsule - excipient ingredients: gelatin; croscarmellose sodium; purified talc; titanium dioxide; colloidal anhydrous silica; microcrystalline cellulose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - multiple myeloma (mm),lenalidomide-teva is indicated for the treatment of multiple myeloma.,myelodysplastic syndromes (mds),lenalidomide-teva is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 24.2 mg - capsule - excipient ingredients: croscarmellose sodium; indigo blue; colloidal anhydrous silica; microcrystalline cellulose; gelatin; titanium dioxide; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - multiple myeloma (mm),lenalidomide-teva is indicated for the treatment of multiple myeloma.,myelodysplastic syndromes (mds),lenalidomide-teva is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 3.025 mg - capsule - excipient ingredients: colloidal anhydrous silica; gelatin; purified talc; croscarmellose sodium; indigo blue; titanium dioxide; iron oxide yellow; microcrystalline cellulose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - multiple myeloma (mm),lenalidomide-teva is indicated for the treatment of multiple myeloma.,myelodysplastic syndromes (mds),lenalidomide-teva is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.