Votubia

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

everolimus

Tillgänglig från:

Novartis Europharm Limited

ATC-kod:

L01XE10

INN (International namn):

everolimus

Terapeutisk grupp:

Antineoplastic agents

Terapiområde:

Tuberous Sclerosis

Terapeutiska indikationer:

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.

Produktsammanfattning:

Revision: 30

Bemyndigande status:

Authorised

Tillstånd datum:

2011-09-02

Bipacksedel

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

Produktens egenskaper

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