Leading the way to safer medication
 Crosscheck  Recommender

CHLORAMBUCIL Film-coated tablets (2015)

Active ingredients: Chlorambucil

Product Name and Form

Chlorambucil 2 mg tablets.

Pharmaceutical form

Brown, round, biconvex, film-coated tablets, one side engraved with “L” and the other side engraved ‘GX EG 3’.

Qualitative and Quantitative Composition

Each tablet contains 2 mg of the active ingredient chlorambucil.

Excipient(s) with known effect: Each tablet also contains 67.65 mg of lactose.

For the full list of excipients, see section 6.1.

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 (E460)
Anhydrous lactose
Colloidal anhydrous silica
Stearic acid (E570)

Tablet Film Coating:

Hypromellose
Titanium dioxide (E171)
Synthetic yellow iron oxide (E172)
Synthetic red iron oxide (E172)
Macrogol

Pack sizes and Marketing

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

Marketing authorization holder
Authorization dates

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

22 June 2006

Marketing authorization number:

PL 39699/0041