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

nch australia pty ltd - glyphosate present as the isopropylamine salt - liquid - glyphosate present as the isopropylamine salt glycine active 360.0 g/l - herbicide - agricultural area - general | avocado | banana | buildings - around | citrus | commercial/industrial land | cotton | domestic an - african boxthorn | african lovegrass | amaranth or amaranthus | amsinckia,yellow burrweed or burr grass | annual or wimmera ryegrass | annual phalaris | annual weeds | apple box | argyle apple | artichoke thistle | barley grass | barnyard or water grass | bent grass - agrostis spp. | bitou bush or boneseed | blackberry | bladder ketmia | blady grass | bracken | brome grass | brown beetle grass - diplachne spp. | bullich | burr medic | californian thistle | caltrop or yellow vine | camel or afghan melon | capeweed | carpet grass | cat's ear or flatweed | chickweed | cobbler's pegs | cocksfoot | common fumitory | common reed or phragmites | couch grass | crofton weed | cudweed | cumbungi | deadnettle | dock - seedling | english couch or rope twitch | flooded gum | fumitory | furze or gorse | ghost gum | ground or annual ground cherry | groundsel bush | guinea grass | gum topped bloodwood | hawthorn | hedge or wild mustard | hoary cress or whiteweed | jarrah | johnson grass | kangaroo grass | kikuyu grass | lant

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - acitretin 10mg; acitretin 10mg - capsule - 10 mg - active: acitretin 10mg excipient: gelatin iron oxide black iron oxide red iron oxide yellow maltodextrin microcrystalline cellulose opacode black s-1-27794 purified water sodium ascorbate sodium laurilsulfate titanium dioxide active: acitretin 10mg excipient: gelatin iron oxide red maltodextrin microcrystalline cellulose opacode black s-1-17823 purified water sodium ascorbate sodium laurilsulfate titanium dioxide - · severe psoriasis.

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - acitretin 25mg; acitretin 25mg - capsule - 25 mg - active: acitretin 25mg excipient: gelatin iron oxide black iron oxide red iron oxide yellow maltodextrin microcrystalline cellulose opacode black s-1-27794 purified water sodium ascorbate sodium laurilsulfate titanium dioxide active: acitretin 25mg excipient: gelatin iron oxide red iron oxide yellow maltodextrin microcrystalline cellulose opacode black s-1-17823 purified water sodium ascorbate sodium laurilsulfate titanium dioxide - · severe psoriasis.

New Zealand - English - Medsafe (Medicines Safety Authority)

carsl consulting - remestemcel-l (100 million human mesenchymal stem cells in 15ml) - solution for infusion - 100 million cells in 15ml - active: remestemcel-l (100 million human mesenchymal stem cells in 15ml) excipient: albumin dimethyl sulfoxide plasma-lyte a - prochymal is indicated for the rescue of patients nlt 6 months to 17 years of age with acute graft versus host disease (agvhd), refractory to treatment with systemic corticosteroid therapy or other immunosuppressive agents. prochymal use under these conditions is limited to grades b to d of the disease.

Malta - English - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - acitretin - capsule - acitretin 25 mg - antipsoriatics

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

novartis pharmaceuticals australia pty ltd - trametinib dimethyl sulfoxide, quantity: 2.254 mg (equivalent: trametinib, qty 2 mg) - tablet, film coated - excipient ingredients: mannitol; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate; hypromellose; titanium dioxide; polysorbate 80; iron oxide red; macrogol 400 - unresectable or metastatic melanoma,mekinist in combination with dabrafenib is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,mekinist as a monotherapy is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma and in whom either there is intolerance to braf inhibitors or braf inhibitors cannot be used.,mekinist as monotherapy has not demonstrated clinical activity in patients who have progressed on braf inhibitor therapy (see section 5.1 clinical trials).,adjuvant treatment of melanoma,mekinist in combination with dabrafenib is indicated for the adjuvant treatment of patients with melanoma with a braf v600 mutation and involvement of the lymph node(s), following complete resection.,anaplastic thyroid cancer (atc),mekinist in combination with dabrafenib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with a braf v600 mutation and with no satisfactory locoregional treatment options.,non-small cell lung cancer (nsclc),mekinist in combination with dabrafenib is indicated for the treatment of patients with advanced non-small cell lung cancer (nsclc) with a braf v600 mutation.,low-grade glioma,mekinist in combination with dabrafenib is indicated for the treatment of paediatric patients 1 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy (see section 5.1 clinical studies).,high-grade glioma,mekinist in combination with dabrafenib is indicated for the treatment of paediatric patients 1 year of age and older with high-grade glioma (hgg) with a braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 5.1 clinical studies). .

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

novartis pharmaceuticals australia pty ltd - trametinib dimethyl sulfoxide, quantity: 0.5635 mg (equivalent: trametinib, qty 0.5 mg) - tablet, film coated - excipient ingredients: sodium lauryl sulfate; hypromellose; mannitol; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; titanium dioxide; iron oxide yellow; macrogol 400 - unresectable or metastatic melanoma,mekinist in combination with dabrafenib is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,mekinist as a monotherapy is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma and in whom either there is intolerance to braf inhibitors or braf inhibitors cannot be used.,mekinist as monotherapy has not demonstrated clinical activity in patients who have progressed on braf inhibitor therapy (see section 5.1 clinical trials).,adjuvant treatment of melanoma,mekinist in combination with dabrafenib is indicated for the adjuvant treatment of patients with melanoma with a braf v600 mutation and involvement of the lymph node(s), following complete resection.,anaplastic thyroid cancer (atc),mekinist in combination with dabrafenib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with a braf v600 mutation and with no satisfactory locoregional treatment options.,non-small cell lung cancer (nsclc),mekinist in combination with dabrafenib is indicated for the treatment of patients with advanced non-small cell lung cancer (nsclc) with a braf v600 mutation.,low-grade glioma,mekinist in combination with dabrafenib is indicated for the treatment of paediatric patients 1 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy (see section 5.1 clinical studies).,high-grade glioma,mekinist in combination with dabrafenib is indicated for the treatment of paediatric patients 1 year of age and older with high-grade glioma (hgg) with a braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 5.1 clinical studies).

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

novartis pharmaceuticals australia pty ltd - dabrafenib mesilate, quantity: 88.88 mg (equivalent: dabrafenib, qty 75 mg) - capsule - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; magnesium stearate; hypromellose; iron oxide red; purified water; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - unresectable or metastatic melanoma,tafinlar in combination with trametinib is indicated for the treatment of patients with brafv600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,tafinlar as monotherapy is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,adjuvant treatment of melanoma,tafinlar in combination with trametinib, is indicated for the adjuvant treatment of patients with a braf v600 mutation and involvement of the lymph node(s), following complete resection.,anaplastic thyroid cancer (atc),tafinlar in combination with trametinib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with a braf v600 mutation and with no satisfactory locoregional treatment options.,non-small cell lung cancer (nsclc),tafinlar in combination with trametinib is indicated for the treatment of patients with advanced non-small cell lung cancer (nsclc) with a braf v600 mutation.,low-grade glioma,tafinlar in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy (see section 5.1 clinical studies).,high-grade glioma,tafinlar in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with high-grade glioma (hgg) with a braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 5.1 clinical studies).

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

novartis pharmaceuticals australia pty ltd - dabrafenib mesilate, quantity: 59.25 mg (equivalent: dabrafenib, qty 50 mg) - capsule - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; magnesium stearate; hypromellose; iron oxide red; purified water; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - unresectable or metastatic melanoma,tafinlar in combination with trametinib is indicated for the treatment of patients with brafv600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,tafinlar as monotherapy is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma.,adjuvant treatment of melanoma,tafinlar in combination with trametinib, is indicated for the adjuvant treatment of patients with a braf v600 mutation and involvement of the lymph node(s), following complete resection.,anaplastic thyroid cancer (atc),tafinlar in combination with trametinib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with a braf v600 mutation and with no satisfactory locoregional treatment options.,non-small cell lung cancer (nsclc),tafinlar in combination with trametinib is indicated for the treatment of patients with advanced non-small cell lung cancer (nsclc) with a braf v600 mutation.,low-grade glioma,tafinlar in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy (see section 5.1 clinical studies).,high-grade glioma,tafinlar in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with high-grade glioma (hgg) with a braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 5.1 clinical studies).

Canada - English - Health Canada

leo pharma inc - azelaic acid - gel - 15% - azelaic acid 15% - misc. skin and mucous membrane agents