SADERON Film-coated tablet Ref.[50159] Active ingredients: Letrozole

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Product name and form

Saderon 2.5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

Yellow, round, biconvex, film-coated tablets, debossed with '‘L9OO’‘ on one side and ’‘2.5’' on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 2.5 mg letrozole.

Excipient(s) with known effect: each film-coated 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

Core tablet:

Lactose monohydrate
Microcrystalline cellulose
Pregelatinized maize starch
Sodium starch glycolate
Magnesium stearate
Colloidal silicon dioxide

Coating:

Hypromellose (HPMC) (E464)
Talc (E553b)
Macrogol (PEG 8000)
Titanium dioxide (E171)
Iron oxide yellow (E172)

Pack sizes and marketing

Saderon film-coated tablets are supplied in PVC/Alu blister packs of 30 tablets.

Marketing authorization holder

Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Marketing authorization dates and numbers

M.L.: 022803

25/05/2018

Drugs

Drug Countries
SADERON Cyprus

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