LETROZOLE / GLENMARK Film-coated tablets Ref.[7504] Active ingredients: Letrozole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom

Product name and form

Letrozole 2.5 mg Film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Dark yellow coloured, round shaped, slightly biconvex bevel edged, approx. 6mm in diameter film-coated tablets debossed with ‘5’ on one side and ‘H’ on the other side.

Qualitative and quantitative composition

Active substance: Letrozole.

Each film coated tablet contains 2.5 mg letrozole.

Excipients with known effect: Each tablet contains 85.0 mg of 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

Core tablets:

Lactose monohydrate
Croscarmellose sodium
Povidone
Silica, colloidal anhydrousmagnesium stearate

Tablet coating:

Hypromellose (464)
Iron oxide, yellow (E172)
Titanium dioxide (E171)
Macrogols
Talc (E553b)

Pack sizes and marketing

Aluminium/Aluminium blister packs and PVC/PE/PVDC/aluminium blister packs.

Pack sizes: 10, 14, 28, 30, 90, 98 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom

Marketing authorization dates and numbers

PL 25258/0198

18/02/2016

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