Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Novartis South Africa (Pty) Ltd, Magwa Crescent West, Waterfall City, Jukskei View, Johannesburg, 2090
AFINITOR 5 mg tablets.
AFINITOR 10 mg tablets.
| Pharmaceutical Form |
|---|
|
White to slightly yellow, elongated tablets with a bevelled edge and no score. 5 mg: The tablets are engraved with “5” on one side and “NVR” on the other. 10 mg: The tablets are engraved with “UHE” on one side and “NVR” on the other. |
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 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) (as antioxidant), magnesium stearate, lactose monohydrate, hypromellose, crospovidone, lactose anhydrous. |
Clear colourless thermoformed PA/Al/PVC (polyamide/aluminium/polyvinylchloride) blisters with silver aluminium foil backing.
Pack size of 30, 60, and 90.
Not all pack sizes may be marketed.
The blister foil is imprinted with the proprietary name, company name, batch number and expiry date.
The blisters are packed into a white cardboard carton.
Novartis South Africa (Pty) Ltd, Magwa Crescent West, Waterfall City, Jukskei View, Johannesburg, 2090
AFINITOR 5 mg tablets: 43/34/1010
AFINITOR 10 mg tablets: 43/34/1133
The date on the registration certificate of the medicine:
AFINITOR 5 mg tablets: 30 September 2011
AFINITOR 10 mg tablets: 30 September 2011
| Drug | Countries | |
|---|---|---|
| AFINITOR | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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