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

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: - patients with active disease despite treatment with methotrexate - patients with active disease who have not previously received methotrexate.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. remsima may be administered in combination with methotrexate.,psoriasis remsima is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established.,crohn?s disease in adults remsima is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.,refractory fistulising crohn?s disease remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

Australia - Kiingereza - 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 - Kiingereza - 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 - Kiingereza - 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 - Kiingereza - 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 - Kiingereza - 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 - Kiingereza - 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 - Kiingereza - 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 - Kiingereza - 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.

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

agribait pty ltd - metaldehyde - bait - metaldehyde aldehyde active 15.0 g/kg - molluscicide - around plants and/or border areas - slug | snail | bradybaena similaris | helix aspersa | sigmurethra | theba pisana