Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Novartis Ireland Limited, Vista Building,, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland
Femara 2.5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. Film-coated tablet, dark yellow, round, slightly biconvex with bevelled edges. One side bears the imprint “FV”, the other “CG”. |
Active substance: letrozole.
Each film-coated tablet contains 2.5 mg letrozole.
Excipient with known effect: each tablet contains 61.5 mg of lactose (monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Letrozole |
Letrozole is a non-steroidal aromatase inhibitor. It inhibits the aromatase enzyme by competitively binding to the haem of the aromatase cytochrome P450, resulting in a reduction of oestrogen biosynthesis in all tissues where present. |
| List of Excipients |
|---|
|
Tablets content: lactose monohydrate, cellulose microcrystalline, maize starch, sodium starch glycolate, magnesium stearate and silica colloidal anhydrous. Coating: hypromellose (E464), talc, macrogol 8000, titanium dioxide (E171) and iron oxide yellow (E172). |
PVC/PE/PVDC/aluminium blisters.
Packs of 10 (1x10), 14 (1x14), 28 (2x14), 30 (3x10), 100 (10 × 10) tablets.
Not all pack sizes may be marketed.
Novartis Ireland Limited, Vista Building,, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland
PA0896/012/001
Date of First Authorisation: 10 January 1997
Date of Last Renewal: 24 July 2006
| Drug | Countries | |
|---|---|---|
| FEMARA | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Singapore, Tunisia, Turkey, United Kingdom, United States |
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