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LEUKERAN Tablets (2012)

Active ingredients: Chlorambucil

Product Name and Form

Leukeran Tablets 2 mg.

Pharmaceutical form

Film-coated tablet.

Qualitative and Quantitative Composition

Each tablet contains 2 mg of the active ingredient chlorambucil.

Chemical substance
Description
Chlorambucil

Chlorambucil is an aromatic nitrogen mustard derivative which acts as a bifunctional alkylating agent. In addition to interference with DNA replication, chlorambucil induces cellular apoptosis via the accumulation of cytosolic p53 and subsequent activation of an apoptosis promoter.

List of excipients

Tablet Core:

Microcrystalline cellulose
Anhydrous lactose
Colloidal anhydrous silica
Stearic acid

Tablet Film Coating:

Hypromellose
Titanium dioxide
Synthetic yellow iron oxide
Synthetic red iron oxide
Macrogol

Pack sizes and Marketing

Leukeran are brown film-coated, round, biconvex tablets engraved “GX EG3” on one side and “L” on the other, supplied in amber glass bottles with a child resistant closure containing 25 tablets.

Marketing authorization holder
Authorization dates

Aspen Pharma Trading Limited
12/13 Exchange Place
I.F.S.C
Dublin 1
Ireland

22.06.2006

Marketing authorization number:

PL 39699/0041