Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Votubia 2.5 mg tablets.
Votubia 5 mg tablets.
Votubia 10 mg tablets.
Pharmaceutical Form |
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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. |
Each tablet contains 2.5 mg everolimus.
Excipient with known effect: Each tablet contains 74 mg lactose.
Each tablet contains 5 mg everolimus.
Excipient with known effect: Each tablet contains 149 mg lactose.
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.
Active Ingredient | Description | |
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Everolimus |
Everolimus is a selective mTOR (mammalian target of rapamycin) inhibitor. mTOR is a key serine-threonine kinase, the activity of which is known to be upregulated in a number of human cancers. |
List of Excipients |
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Butylated hydroxytoluene (E321) |
Aluminium/polyamide/aluminium/PVC perforated unit-dose blister containing 10 × 1 tablets.
Votubia 2.5 mg tablets:
Packs containing 10 × 1, 30 × 1 or 100 × 1 tablets.
Votubia 5 mg tablets:
Packs containing 30 × 1 or 100 × 1 tablets.
Votubia 10 mg tablets:
Packs containing 10 × 1, 30 × 1 or 100 × 1 tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Votubia 2.5 mg tablets:
EU/1/11/710/001-003
Votubia 5 mg tablets:
EU/1/11/710/004-005
Votubia 10 mg tablets:
EU/1/11/710/006-008
Date of first authorisation: 02 September 2011
Date of latest renewal: 23 July 2020
Drug | Countries | |
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VOTUBIA | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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