Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
trametinib
Novartis Europharm Limited
L01EE01
trametinib
Antineoplastic agents
Melanoma
MelanomaTrametinib 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 (see sections 4.4 and 5.1).Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1).Adjuvant treatment of melanomaTrametinib 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.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.
Revision: 29
Authorised
2014-06-30
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Mekinist 0.5 mg film-coated tablets Mekinist 2 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mekinist 0.5 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib. Mekinist 2 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg of trametinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Mekinist 0.5 mg film-coated tablets Yellow, modified oval, biconvex, film-coated tablets, approximately 5.0 x 9.0 mm, with the company logo debossed on one face and “TT” on the opposing face. Mekinist 2 mg film-coated tablets Pink, round, biconvex, film-coated tablets, approximately 7.6 mm, with the company logo debossed on one face and “LL” on the opposing face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Melanoma 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 (see sections 4.4 and 5.1). Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1). 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. 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. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with trametinib should only be initiated and supervised by a physician experienced in the administration of anti-cancer medicinal products. Before taking trametinib, patients must have confirmation of BRAF V600 mutation using a validated tes Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Mekinist 0.5 mg film-coated tablets Mekinist 2 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mekinist 0.5 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib. Mekinist 2 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg of trametinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Mekinist 0.5 mg film-coated tablets Yellow, modified oval, biconvex, film-coated tablets, approximately 5.0 x 9.0 mm, with the company logo debossed on one face and “TT” on the opposing face. Mekinist 2 mg film-coated tablets Pink, round, biconvex, film-coated tablets, approximately 7.6 mm, with the company logo debossed on one face and “LL” on the opposing face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Melanoma 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 (see sections 4.4 and 5.1). Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1). 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. 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. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with trametinib should only be initiated and supervised by a physician experienced in the administration of anti-cancer medicinal products. Before taking trametinib, patients must have confirmation of BRAF V600 mutation using a validated tes Прочетете целия документ