LETROLE Film-coated tablet Ref.[50649] Active ingredients: Letrozole

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2022  Publisher: Viatris Ltd, PO Box 11-183, Ellerslie, AUCKLAND www.viatris.co.nz Telephone 0800 168 169

Product name and form

Letrole, 2.5 mg, film coated tablet.

Pharmaceutical Form

Dark yellow, capsule shape, film-coated, slightly biconvex tablet, debossed with “LZ 2.5” on one side and “G” on the other.

Qualitative and quantitative composition

Each film coated tablet contains 2.5 mg of letrozole.

Excipient with known effect: Lactose.

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

Letrole 2.5mg tablet core contains:

Lactose monohydrate
Microcrystalline cellulose
Maize starch
Sodium starch glycollate
Magnesium stearate
Colloidal silicon dioxide

Letrole 2.5mg tablet film coating contains:

Hypromellose
Polydextrose
Triacetin
Macrogol
Iron oxide yellow (E172)
Quinoline yellow aluminium lake (E104)
Iron oxide red (E172)
Titanium dioxide

Pack sizes and marketing

PVC/PVdC/Aluminium blister. Pack size of 30 film-coated tablets.

Marketing authorization holder

Viatris Ltd, PO Box 11-183, Ellerslie, AUCKLAND
www.viatris.co.nz
Telephone 0800 168 169

Marketing authorization dates and numbers

Date of first approval: 1 April 2010

Drugs

Drug Countries
LETROLE Ecuador, New Zealand

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