European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - mycophenolate mofetil - graft rejection - immunosuppressants - mycophenolate mofetil teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

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

teva pharma australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: monobasic sodium phosphate monohydrate; dibasic sodium phosphate dihydrate; sucrose - azacitidine-teva is indicated for the treatment of patients with: intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), chronic myelomonocytic leukemia [cmmol (10 percent-29 percent marrow blasts without myeloproliferative disorder)], acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated

Australia - English - 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 - English - 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 - English - 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 - English - 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.

European Union - English - 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).

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

teva pharmaceuticals (pty) ltd - solution for injection - not indicated - each vial of 5 ml of solution contains palonosetron (as hydrochloride) 0,25 mg

Australia - English - 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.

Australia - English - 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.