Negara: Uni Eropa
Bahasa: Inggris
Sumber: EMA (European Medicines Agency)
everolimus
Novartis Europharm Limited
L01XE10
everolimus
Antineoplastic agents
Tuberous Sclerosis
Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.The evidence is based on analysis of change in sum of angiomyolipoma volume.Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease‑related symptoms, has not been demonstrated.
Revision: 30
Authorised
2011-09-02
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Votubia 2.5 mg tablets Each tablet contains 2.5 mg everolimus. _Excipient with known effect _ Each tablet contains 74 mg lactose. Votubia 5 mg tablets Each tablet contains 5 mg everolimus. _Excipient with known effect _ Each tablet contains 149 mg lactose. Votubia 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. Votubia 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. Votubia 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. Votubia 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 Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with TSC who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery. The evidence is based on analysis of change in sum of angiomyolipoma volume. Subependymal giant cell astrocytoma (SEGA) associated with TSC Votubia is indicated for the treatment of adult and paediatric patients with SEGA associated with TSC who require therapeutic intervention but are not amenable to surgery. The evi Baca dokumen lengkapnya
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Votubia 2.5 mg tablets Each tablet contains 2.5 mg everolimus. _Excipient with known effect _ Each tablet contains 74 mg lactose. Votubia 5 mg tablets Each tablet contains 5 mg everolimus. _Excipient with known effect _ Each tablet contains 149 mg lactose. Votubia 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. Votubia 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. Votubia 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. Votubia 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 Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with TSC who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery. The evidence is based on analysis of change in sum of angiomyolipoma volume. Subependymal giant cell astrocytoma (SEGA) associated with TSC Votubia is indicated for the treatment of adult and paediatric patients with SEGA associated with TSC who require therapeutic intervention but are not amenable to surgery. The evi Baca dokumen lengkapnya