New Zealand - engelsk - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - isotretinoin 30mg;  ;   - soft gelatin capsule - 30 mg - active: isotretinoin 30mg     excipient: butylated hydroxyanisole disodium edetate dihydrate dl-alpha tocopherol gelatin glycerol iron oxide red sorbitol soya bean oil, hydrogenated   soya oil titanium dioxide yellow beeswax - severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - isotretinoin 40mg;  ;   - soft gelatin capsule - 40 mg - active: isotretinoin 40mg     excipient: butylated hydroxyanisole disodium edetate dihydrate gelatin glycerol all-rac-alpha-tocopherol purified water sorbitol soya bean oil, hydrogenated   soya oil sunset yellow fcf titanium dioxide yellow beeswax - severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. oratane should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, and understand the risk of teratogenicity if oratane is used during pregnancy.

Singapore - engelsk - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - immunoglobulin g - injection, powder, for solution - 48-56 mg/ml - immunoglobulin g 48-56 mg/ml

Canada - engelsk - Health Canada

hope pharmaceuticals ltd - sodium nitrite - solution - 30mg - sodium nitrite 30mg - antidotes

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - budesonide 2 mg/ml ((100 micrograms/spray));   - nasal spray suspension - 100 mcg/dose - active: budesonide 2 mg/ml ((100 micrograms/spray))   excipient: disodium edetate dispersible cellulose glucose hydrochloric acid polysorbate 80 potassium sorbate purified water - for the prevention and treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis. for the symptomatic relief of nasal polyposis.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - budesonide 1 mg/ml ((50 micrograms/spray));   - nasal spray suspension - 50 mcg/dose - active: budesonide 1 mg/ml ((50 micrograms/spray))   excipient: disodium edetate dispersible cellulose glucose hydrochloric acid polysorbate 80 potassium sorbate purified water - for the short-term prevention and treatment of seasonal allergic rhinitis (hayfever)

Irland - engelsk - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - imatinib - film-coated tablet - 100 milligram(s) - other antineoplastic agents - protein-tyrosine kinase inhibitor - imatinib is indicated for the treatment of: paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult patients with ph+ cml in blast crisis adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr
rearrangement.

Irland - engelsk - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - imatinib - film-coated tablet - 400 milligram(s) - other antineoplastic agents - protein-tyrosine kinase inhibitor - imatinib is indicated for the treatment of: paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult patients with ph+ cml in blast crisis adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr
rearrangement. adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) an

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

juno pharmaceuticals pty ltd - imatinib mesilate -

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

juno pharmaceuticals pty ltd - imatinib mesilate -