Australia - inglés - 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.

Australia - inglés - 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.

Australia - inglés - 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.

Australia - inglés - 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.

Unión Europea - inglés - EMA (European Medicines Agency)

teva pharma b.v. - pramipexole dihydrochloride monohydrate - parkinson disease - anti-parkinson drugs - pramipexole teva is indicated for treatment of the signs and symptoms of idiopathic parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).pramipexole teva is indicated in adults for symptomatic treatment of moderate to severe idiopathic restless legs syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).

Sudáfrica - inglés - South African Health Products Regulatory Authority (SAHPRA)

teva pharmaceuticals (pty) ltd - #n/a - not indicated - none

Israel - inglés - Ministry of Health

teva israel ltd - cinacalcet as hydrochloride - tablets - cinacalcet as hydrochloride 30 mg - cinacalcet - treatment of secondary hyperparathyrodism (hpt) in patients with end-dtage renal disease (esrd) on maintenance dialysis therapy. cinacalcet teva may be used as part of a therapeutic regimen including phosphate binders and/or vitamin d sterols, as appropriate. reduction of hypercalcaemia in patients with parathyroid carcinoma.reduction of hypercalcaemia in patients with:• parathyroid carcinoma.• primary hpt for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Israel - inglés - Ministry of Health

teva israel ltd - cinacalcet as hydrochloride - tablets - cinacalcet as hydrochloride 60 mg - cinacalcet - treatment of secondary hyperparathyrodism (hpt) in patients with end-dtage renal disease (esrd) on maintenance dialysis therapy. cinacalcet teva may be used as part of a therapeutic regimen including phosphate binders and/or vitamin d sterols, as appropriate. reduction of hypercalcaemia in patients with parathyroid carcinoma.reduction of hypercalcaemia in patients with:• parathyroid carcinoma.• primary hpt for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Israel - inglés - Ministry of Health

teva israel ltd - cinacalcet as hydrochloride - tablets - cinacalcet as hydrochloride 90 mg - cinacalcet - treatment of secondary hyperparathyrodism (hpt) in patients with end-dtage renal disease (esrd) on maintenance dialysis therapy. cinacalcet teva may be used as part of a therapeutic regimen including phosphate binders and/or vitamin d sterols, as appropriate. reduction of hypercalcaemia in patients with parathyroid carcinoma.reduction of hypercalcaemia in patients with:• parathyroid carcinoma.• primary hpt for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

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

teva pharma australia pty ltd - glatiramer acetate, quantity: 40 mg - injection, solution - excipient ingredients: mannitol; water for injections - glatiramer acetate is indicated for the: 1- reduction of the frequency of relapses in patients with relapsing remitting multiple sclerosis. 2-treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent mri lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.