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

teva uk ltd - erlotinib hydrochloride - oral tablet - 100mg

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

accord-uk ltd - erlotinib hydrochloride - oral tablet - 100mg

New Zealand - English - Medsafe (Medicines Safety Authority)

alchemy health limited - erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg - film coated tablet - 25 mg - active: erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg excipient: lactose monohydrate magnesium stearate microcrystalline cellulose opadry white 200f280000 sodium starch glycolate - erlotinib is indicated for the first-line and maintenance treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations. erlotinib is also indicated for the treatment of patients with locally advanced or metastatic nsclc who have previously received chemotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

alchemy health limited - erlotinib hydrochloride 54.63mg equivalent to erlotinib 50mg - film coated tablet - 50 mg - active: erlotinib hydrochloride 54.63mg equivalent to erlotinib 50mg excipient: lactose monohydrate magnesium stearate microcrystalline cellulose opadry white 200f280000 sodium starch glycolate - erlotinib is indicated for the first-line and maintenance treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations. erlotinib is also indicated for the treatment of patients with locally advanced or metastatic nsclc who have previously received chemotherapy.

Israel - English - Ministry of Health

novartis israel ltd - trametinib as dimethyl sulfoxide - film coated tablets - trametinib as dimethyl sulfoxide 0.5 mg - trametinib - trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy. non-small cell lung cancer (nsclc) :trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.adjuvant treatment of melanoma :trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a 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 tumorsmekinist is indicated, in combination with dabrafenib, 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: trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to braf inhibitiontrametinib is indicated, in combination with dabrafenib, 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 - trametinib as dimethyl sulfoxide - film coated tablets - trametinib as dimethyl sulfoxide 2 mg - trametinib - trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy. non-small cell lung cancer (nsclc) :trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.adjuvant treatment of melanoma :trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a 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 tumorsmekinist is indicated, in combination with dabrafenib, 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: trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to braf inhibitiontrametinib is indicated, in combination with dabrafenib, 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

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).

Singapore - English - HSA (Health Sciences Authority)

intega pte ltd - erlotinib hydrochloride eqv erlotinib - tablet, film coated - erlotinib hydrochloride eqv erlotinib 100.00mg

Singapore - English - HSA (Health Sciences Authority)

intega pte ltd - erlotinib hydrochloride eqv erlotinib - tablet, film coated - erlotinib hydrochloride eqv erlotinib 150.00mg