Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
everolimus
Novartis Europharm Limited
L01XE10
everolimus
Antineoplastic agents
Carcinoma, Renal Cell; Breast Neoplasms; Pancreatic Neoplasms
Hormone-receptor-positive advanced breast cancerAfinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.Neuroendocrine tumours of pancreatic originAfinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.Neuroendocrine tumours of gastrointestinal or lung originAfinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.Renal-cell carcinomaAfinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
Revision: 30
Authorised
2009-08-02
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Afinitor 2.5 mg tablets Each tablet contains 2.5 mg everolimus. _Excipient with known effect _ Each tablet contains 74 mg lactose. Afinitor 5 mg tablets Each tablet contains 5 mg everolimus. _Excipient with known effect _ Each tablet contains 149 mg lactose. Afinitor 10 mg tablets Each tablet contains 10 mg everolimus. _Excipient with known effect _ Each tablet contains 297 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Afinitor 2.5 mg tablets White to slightly yellow, elongated tablets of approximately 10.1 mm in length and 4.1 mm in width, with a bevelled edge and no score, engraved with “LCL” on one side and “NVR” on the other. Afinitor 5 mg tablets White to slightly yellow, elongated tablets of approximately 12.1 mm in length and 4.9 mm in width, with a bevelled edge and no score, engraved with “5” on one side and “NVR” on the other. Afinitor 10 mg tablets White to slightly yellow, elongated tablets of approximately 15.1 mm in length and 6.0 mm in width, with a bevelled edge and no score, engraved with “UHE” on one side and “NVR” on the other. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Neuroendocrine tumours of pancreatic origin Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Neuroendocrine tumours of gastrointestinal or lung origin Afinitor is indicated for the treatment of unr Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Afinitor 2.5 mg tablets Each tablet contains 2.5 mg everolimus. _Excipient with known effect _ Each tablet contains 74 mg lactose. Afinitor 5 mg tablets Each tablet contains 5 mg everolimus. _Excipient with known effect _ Each tablet contains 149 mg lactose. Afinitor 10 mg tablets Each tablet contains 10 mg everolimus. _Excipient with known effect _ Each tablet contains 297 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Afinitor 2.5 mg tablets White to slightly yellow, elongated tablets of approximately 10.1 mm in length and 4.1 mm in width, with a bevelled edge and no score, engraved with “LCL” on one side and “NVR” on the other. Afinitor 5 mg tablets White to slightly yellow, elongated tablets of approximately 12.1 mm in length and 4.9 mm in width, with a bevelled edge and no score, engraved with “5” on one side and “NVR” on the other. Afinitor 10 mg tablets White to slightly yellow, elongated tablets of approximately 15.1 mm in length and 6.0 mm in width, with a bevelled edge and no score, engraved with “UHE” on one side and “NVR” on the other. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Neuroendocrine tumours of pancreatic origin Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Neuroendocrine tumours of gastrointestinal or lung origin Afinitor is indicated for the treatment of unr Pročitajte cijeli dokument