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

sun pharma anz pty ltd - fingolimod hydrochloride, quantity: 560 microgram (equivalent: fingolimod, qty 500 microgram) - capsule, hard - excipient ingredients: polacrilin potassium; crospovidone; colloidal anhydrous silica; magnesium stearate; gelatin; sodium lauryl sulfate; titanium dioxide; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - fingolimod sun 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.

Kesatuan Eropah - Inggeris - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type 2 diabetes mellitus, sitagliptin sun is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i.e. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control.as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

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

sun pharma anz pty ltd - dasatinib, quantity: 100 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; calcium hydrogen phosphate; lactose monohydrate; hyprolose; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; triacetin - dasatinib sun is indicated for the treatment of adults aged 18 years or over with:,? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase.,? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.,? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.,? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib sun is indicated for the treatment of paediatric patients with:,? ph+ cml in the chronic phase.,? newly diagnosed ph+ all in combination with chemotherapy.

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

sun pharma anz pty ltd - dasatinib, quantity: 100 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; lactose monohydrate; croscarmellose sodium; calcium hydrogen phosphate; hyprolose; titanium dioxide; hypromellose; triacetin - dasatinib sun is indicated for the treatment of adults aged 18 years or over with:,? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase.,? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.,? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.,? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib sun is indicated for the treatment of paediatric patients with:,? ph+ cml in the chronic phase.,? newly diagnosed ph+ all in combination with chemotherapy.

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

sun pharma anz pty ltd - dasatinib, quantity: 50 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; calcium hydrogen phosphate; magnesium stearate; colloidal anhydrous silica; hyprolose; titanium dioxide; hypromellose; triacetin - dasatinib sun is indicated for the treatment of adults aged 18 years or over with:,? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase.,? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.,? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.,? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib sun is indicated for the treatment of paediatric patients with:,? ph+ cml in the chronic phase.,? newly diagnosed ph+ all in combination with chemotherapy.

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

sun pharma anz pty ltd - dasatinib, quantity: 70 mg - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; lactose monohydrate; hyprolose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; triacetin - dasatinib sun is indicated for the treatment of adults aged 18 years or over with:,? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase.,? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.,? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.,? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib sun is indicated for the treatment of paediatric patients with:,? ph+ cml in the chronic phase.,? newly diagnosed ph+ all in combination with chemotherapy.

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

sun pharma anz pty ltd - dasatinib, quantity: 20 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; hyprolose; lactose monohydrate; calcium hydrogen phosphate; croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; triacetin - dasatinib sun is indicated for the treatment of adults aged 18 years or over with:,? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase.,? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.,? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.,? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib sun is indicated for the treatment of paediatric patients with:,? ph+ cml in the chronic phase.,? newly diagnosed ph+ all in combination with chemotherapy.

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

sun pharma anz pty ltd - dasatinib, quantity: 50 mg - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; croscarmellose sodium; colloidal anhydrous silica; lactose monohydrate; hyprolose; magnesium stearate; titanium dioxide; hypromellose; triacetin - dasatinib sun is indicated for the treatment of adults aged 18 years or over with:,? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase.,? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.,? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.,? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib sun is indicated for the treatment of paediatric patients with:,? ph+ cml in the chronic phase.,? newly diagnosed ph+ all in combination with chemotherapy.

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

sun pharma anz pty ltd - dasatinib, quantity: 20 mg - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; hyprolose; colloidal anhydrous silica; croscarmellose sodium; lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; triacetin - dasatinib sun is indicated for the treatment of adults aged 18 years or over with:,? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase.,? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.,? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.,? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib sun is indicated for the treatment of paediatric patients with:,? ph+ cml in the chronic phase.,? newly diagnosed ph+ all in combination with chemotherapy.

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

sun pharma anz pty ltd - dasatinib, quantity: 70 mg - tablet, film coated - excipient ingredients: lactose monohydrate; hyprolose; colloidal anhydrous silica; magnesium stearate; croscarmellose sodium; calcium hydrogen phosphate; titanium dioxide; hypromellose; triacetin - dasatinib sun is indicated for the treatment of adults aged 18 years or over with:,? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase.,? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.,? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.,? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib sun is indicated for the treatment of paediatric patients with:,? ph+ cml in the chronic phase.,? newly diagnosed ph+ all in combination with chemotherapy.