Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Votubia 1 mg dispersible tablets.
Votubia 2 mg dispersible tablets.
Votubia 3 mg dispersible tablets.
Votubia 5 mg dispersible tablets.
| Pharmaceutical Form |
|---|
|
Dispersible tablet. Votubia 1 mg dispersible tablets: White to slightly yellowish, round, flat tablets of approximately 7.1 mm in diameter, with a bevelled edge and no score, engraved with “D1” on one side and “NVR” on the other. Votubia 2 mg dispersible tablets: White to slightly yellowish, round, flat tablets of approximately 9.1 mm in diameter, with a bevelled edge and no score, engraved with “D2” on one side and “NVR” on the other. Votubia 3 mg dispersible tablets: White to slightly yellowish, round, flat tablets of approximately 10.1 mm in diameter, with a bevelled edge and no score, engraved with “D3” on one side and “NVR” on the other. Votubia 5 mg dispersible tablets: White to slightly yellowish, round, flat tablets of approximately 12.1 mm in diameter, with a bevelled edge and no score, engraved with “D5” on one side and “NVR” on the other. |
Each dispersible tablet contains 1 mg everolimus.
Excipient with known effect: Each dispersible tablet contains 0.98 mg lactose.
Each dispersible tablet contains 2 mg everolimus.
Excipient with known effect: Each dispersible tablet contains 1.96 mg lactose.
Each dispersible tablet contains 3 mg everolimus.
Excipient with known effect: Each dispersible tablet contains 2.94 mg lactose.
Each dispersible tablet contains 5 mg everolimus.
Excipient with known effect: Each dispersible tablet contains 4.90 mg lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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 |
|---|
|
Butylated hydroxytoluene (E321) |
Aluminium/polyamide/aluminium/PVC perforated unit-dose blister containing 10 × 1 dispersible tablets.
Votubia 1 mg dispersible tablets: Packs containing 30 × 1 dispersible tablets.
Votubia 2 mg dispersible tablets: Packs containing 10 × 1, 30 × 1 or 100 × 1 dispersible tablets.
Votubia 3 mg dispersible tablets: Packs containing 30 × 1 or 100 × 1 dispersible tablets.
Votubia 5 mg dispersible tablets: Packs containing 30 × 1 or 100 × 1 dispersible tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Votubia 1 mg dispersible tablets: EU/1/11/710/016
Votubia 2 mg dispersible tablets: EU/1/11/710/009-011
Votubia 3 mg dispersible tablets: EU/1/11/710/012-013
Votubia 5 mg dispersible tablets: EU/1/11/710/014-015
Date of first authorisation: 02 September 2011
Date of latest renewal: 28 July 2015
| Drug | Countries | |
|---|---|---|
| VOTUBIA | Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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