New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 119.5mg equivalent to 100 mg imatinib base - capsule - 100 mg - active: imatinib mesilate 119.5mg equivalent to 100 mg imatinib base excipient: colloidal silicon dioxide crospovidone gelatin iron oxide red iron oxide yellow magnesium stearate microcrystalline cellulose tekprint red sw-1102 titanium dioxide - · treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). · treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. · treatment of adult patients with new diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy. · treatment of adult patients with relapsed or refractory ph+all as monotherapy. · treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. · treatment of adult patients with systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 59.75mg equivalent to 50 mg imatinib base - capsule - 50 mg - active: imatinib mesilate 59.75mg equivalent to 50 mg imatinib base excipient: colloidal silicon dioxide crospovidone gelatin iron oxide yellow magnesium stearate microcrystalline cellulose titanium dioxide - · treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). · treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. · treatment of adult patients with new diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy. · treatment of adult patients with relapsed or refractory ph+all as monotherapy. · treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. · treatment of adult patients with systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 119.5mg equivalent to imatinib base 100 mg;   - film coated tablet - 100 mg - active: imatinib mesilate 119.5mg equivalent to imatinib base 100 mg   excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry red 00f15613 opadry yellow 00f12951 purified water - · treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). · treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. · treatment of adult patients with new diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy. · treatment of adult patients with relapsed or refractory ph+all as monotherapy. · treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. · treatment of adult patients with systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 478mg equivalent to imatinib base 400 mg;   - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib base 400 mg   excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry red 00f15613 opadry yellow 00f12951 purified water - · treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). · treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. · treatment of adult patients with new diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy. · treatment of adult patients with relapsed or refractory ph+all as monotherapy. · treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. · treatment of adult patients with systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - methylphenidate hydrochloride 10mg;   - tablet - 10 mg - active: methylphenidate hydrochloride 10mg   excipient: calcium phosphate gelatin lactose monohydrate magnesium stearate purified talc wheat starch - ritalin/ritalin sr is indicated in the treatment of attention-deficit/hyperactivity disorder in children aged 6 years or older. ritalin la is indicated in the treatment of attention-deficit/hyperactivity disorder in children aged 6 years or older and in adults. ritalin/ritalin sr is indicated for the treatment of narcolepsy in adults. symptoms include daytime sleepiness, inappropriate sleep episodes, and sudden loss of voluntary muscle tone.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - methylphenidate hydrochloride 10mg;   - modified release capsule - 10 mg - active: methylphenidate hydrochloride 10mg   excipient: ammonio methacrylate copolymer gelatin macrogol 6000 methacrylic acid copolymer purified talc sugar spheres tekprint tan sw-8010 titanium dioxide triethyl citrate - ritalin/ritalin sr is indicated in the treatment of attention-deficit/hyperactivity disorder in children aged 6 years or older. ritalin la is indicated in the treatment of attention-deficit/hyperactivity disorder in children aged 6 years or older and in adults. ritalin/ritalin sr is indicated for the treatment of narcolepsy in adults. symptoms include daytime sleepiness, inappropriate sleep episodes, and sudden loss of voluntary muscle tone.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - methylphenidate hydrochloride 20mg;   - modified release capsule - 20 mg - active: methylphenidate hydrochloride 20mg   excipient: ammonio methacrylate copolymer gelatin methacrylic acid copolymer type a-methacrylate acid-methacrylate copolymer 1:1, dry powder macrogol 6000 purified talc sugar spheres titanium dioxide triethyl citrate - ritalin/ritalin sr is indicated in the treatment of attention-deficit/hyperactivity disorder in children aged 6 years or older. ritalin la is indicated in the treatment of attention-deficit/hyperactivity disorder in children aged 6 years or older and in adults. ritalin/ritalin sr is indicated for the treatment of narcolepsy in adults. symptoms include daytime sleepiness, inappropriate sleep episodes, and sudden loss of voluntary muscle tone.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - methylphenidate hydrochloride 30mg;   - modified release capsule - 30 mg - active: methylphenidate hydrochloride 30mg   excipient: ammonio methacrylate copolymer gelatin methacrylic acid copolymer type a/methacrylic acid methacrylate copolymer 1:1, dry powder iron oxide yellow macrogol 6000 purified talc sugar spheres titanium dioxide triethyl citrate - ritalin/ritalin sr is indicated in the treatment of attention-deficit/hyperactivity disorder in children aged 6 years or older. ritalin la is indicated in the treatment of attention-deficit/hyperactivity disorder in children aged 6 years or older and in adults. ritalin/ritalin sr is indicated for the treatment of narcolepsy in adults. symptoms include daytime sleepiness, inappropriate sleep episodes, and sudden loss of voluntary muscle tone.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - methylphenidate hydrochloride 40mg;   - modified release capsule - 40 mg - active: methylphenidate hydrochloride 40mg   excipient: ammonio methacrylate copolymer gelatin methacrylic acid copolymer type a -/methacryllic acid-methacrylate coplymer 1:1 dry powder iron oxide black iron oxide red iron oxide yellow macrogol 6000 purified talc sugar spheres titanium dioxide triethyl citrate - ritalin/ritalin sr is indicated in the treatment of attention-deficit/hyperactivity disorder in children aged 6 years or older. ritalin la is indicated in the treatment of attention-deficit/hyperactivity disorder in children aged 6 years or older and in adults. ritalin/ritalin sr is indicated for the treatment of narcolepsy in adults. symptoms include daytime sleepiness, inappropriate sleep episodes, and sudden loss of voluntary muscle tone.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - methylphenidate hydrochloride 20mg;  ;   - modified release tablet - 20 mg - active: methylphenidate hydrochloride 20mg     excipient: carbon dioxide carnauba wax cetostearyl alcohol hypromellose ink lactose monohydrate magnesium stearate methylated spirits polyethylene glycol hydrogenated castor oil purified talc purified water titanium dioxide - ritalin/ritalin sr is indicated in the treatment of attention-deficit/hyperactivity disorder in children aged 6 years or older. ritalin la is indicated in the treatment of attention-deficit/hyperactivity disorder in children aged 6 years or older and in adults. ritalin/ritalin sr is indicated for the treatment of narcolepsy in adults. symptoms include daytime sleepiness, inappropriate sleep episodes, and sudden loss of voluntary muscle tone.