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

elanco australasia pty ltd - levamisole hydrochloride; fenbendazole; naphthalophos - oral solution/suspension - levamisole hydrochloride anthelmintic active 80.0 g/l; fenbendazole carbamate-benzimidazole active 50.0 g/l; naphthalophos organophosphorus active 800.0 g/kg - parasiticides - lamb | sheep | ewe | hogget | lamb | ovine | ram | weaner | wether - lungworm | roundworm | toxocara mystax | toxocara spp.

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

pharm smart australia pty ltd - naphthalophos - powder - naphthalophos organophosphorus active 800.0 g/kg - parasiticides

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

novartis pharma ag - trametinib (dimetil sulfoxido) - trametinib (dimetil sulfoxido)....2.00mg

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

novartis pharma ag - trametinib (dimetil sulfoxido) - trametinib (dimetil sulfoxido)....0.50mg

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

novartis pharmaceuticals australia pty ltd - trametinib dimethyl sulfoxide, quantity: 0.0564 mg/ml (equivalent: trametinib, qty 0.05 mg/ml) - solution, powder for - excipient ingredients: sulfobutyl betadex sodium; sucralose; citric acid monohydrate; dibasic sodium phosphate; potassium sorbate; methyl hydroxybenzoate; flavour - 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).

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - dabrafenib mesilate - melanoma - antineoplastic agents - melanomadabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4.4 and 5.1).adjuvant treatment of melanomadabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection.non-small cell lung cancer (nsclc)dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.

Israel - English - Ministry of Health

novartis israel ltd - dabrafenib as mesilate - hard capsule - dabrafenib as mesilate 50 mg - dabrafenib - dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation.non-small cell lung cancer (nsclc) :dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.adjuvant treatment of melanoma :dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with braf v600 mutation, following complete resection.braf v600e mutation-positive locally advanced or metastatic anaplastic thyroid cancertafinlar is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment optionsbraf v600e mutation-positive unresectable or metastatic solid tumorstafinlar is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. limitations of use: dabrafenib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to braf inhibition. dabrafenib is indicated, in combination with trametinib, for the treatment of pediatric patients 6 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy

Israel - English - Ministry of Health

novartis israel ltd - dabrafenib as mesilate - hard capsule - dabrafenib as mesilate 50 mg - dabrafenib - dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation.non-small cell lung cancer (nsclc) :dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.adjuvant treatment of melanoma : dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with braf v600 mutation, following complete resection.braf v600e mutation-positive locally advanced or metastatic anaplastic thyroid cancertafinlar is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment options

Israel - English - Ministry of Health

novartis israel ltd - dabrafenib as mesilate - hard capsule - dabrafenib as mesilate 75 mg - dabrafenib - dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation.non-small cell lung cancer (nsclc)dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.adjuvant treatment of melanoma :dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with braf v600 mutation, following complete resection.braf v600e mutation-positive locally advanced or metastatic anaplastic thyroid cancertafinlar is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment optionsbraf v600e mutation-positive unresectable or metastatic solid tumorstafinlar is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. limitations of use: dabrafenib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to braf inhibition. dabrafenib is indicated, in combination with trametinib, for the treatment of pediatric patients 6 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy

Ireland - English - HPRA (Health Products Regulatory Authority)

a/s alfred benzon - ibuprofen - tablets - 200 milligram