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).

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - dabrafenib mesilate 59.25mg equivalent to dabrafenib 50 mg;  ;   - capsule - 50 mg - active: dabrafenib mesilate 59.25mg equivalent to dabrafenib 50 mg     excipient: colloidal silicon dioxide hypromellose iron oxide red magnesium stearate microcrystalline cellulose purified water titanium dioxide - tafinlar is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma. tafinlar in combination with trametinib is indicated for the treatment of patients with unresectable or metastatic melanoma with a braf v600 mutation. tafinlar in combination with mekinist, is indicated for the adjuvant treatment of patients with stage iii melanoma with a braf v600 mutation, following complete resection.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - dabrafenib mesilate 88.88mg equivalent to dabrafenib 75 mg;  ;   - capsule - 75 mg - active: dabrafenib mesilate 88.88mg equivalent to dabrafenib 75 mg     excipient: colloidal silicon dioxide hypromellose iron oxide red magnesium stearate microcrystalline cellulose purified water titanium dioxide - tafinlar is indicated for the treatment of patients with braf v600 mutation positive unresectable stage iii or metastatic (stage iv) melanoma. tafinlar in combination with trametinib is indicated for the treatment of patients with unresectable or metastatic melanoma with a braf v600 mutation. tafinlar in combination with mekinist, is indicated for the adjuvant treatment of patients with stage iii melanoma with a braf v600 mutation, following complete resection.

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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - dabrafenib mesilate - capsule - 50mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - dabrafenib mesilate - capsule - 75mg

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