AFINITOR Tablet Ref.[50349] Active ingredients: Everolimus

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

Afinitor 2.5 mg tablets.

Afinitor 5 mg tablets.

Afinitor 10 mg tablets.

Pharmaceutical Form

Tablet.

Afinitor 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.

Afinitor 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.

Afinitor 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.

Qualitative and quantitative composition

Afinitor 2.5 mg tablets

Each tablet contains 2.5 mg everolimus.

Excipient with known effect: Each tablet contains 74 mg lactose.

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 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

Butylhydroxytoluene
Magnesium stearate
Lactose monohydrate
Hypromellose
Crospovidone type A
Lactose anhydrous

Pack sizes and marketing

Aluminium/polyamide/aluminium/PVC blister containing 10 tablets.

Afinitor 2.5 mg tablets: Packs containing 30 or 90 tablets.

Afinitor 5 mg tablets: Packs containing 10, 30 or 90 tablets.

Afinitor 10 mg tablets: Packs containing 10, 30 or 90 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

Afinitor 2.5 mg tablets:

EU/1/09/538/009
EU/1/09/538/010

Afinitor 5 mg tablets:

EU/1/09/538/001
EU/1/09/538/003
EU/1/09/538/007

Afinitor 10 mg tablets:

EU/1/09/538/004
EU/1/09/538/006
EU/1/09/538/008

Date of first authorisation: 03 August 2009
Date of latest renewal: 02 April 2019

Drugs

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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