MELPHALAN Film-coated tablets Ref.[8200] Active ingredients: Melphalan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Melphalan 2 mg Tablets.

Pharmaceutical Form

Film-coated tablets.

MELPHALAN are white to off-white film-coated, round, biconvex tablets engraved “GX EH3” on one side and “A” on the other.

Qualitative and quantitative composition

Each tablet contains 2 mg melphalan.

Active Ingredient Description
Melphalan

Melphalan is a bifunctional alkylating agent. Formation of carbonium intermediates from each of the two bis-2-chloroethyl groups enables alkylation through covalent binding with the 7-nitrogen of guanine on DNA, cross-linking the two DNA strands and thereby preventing cell replication.
List of Excipients

Tablet Core:

Microcrystalline cellulose
Crospovidone
Colloidal anhydrous silica
Magnesium stearate

Tablet Film Coating:

Hypromellose
Titanium dioxide
Macrogol

Pack sizes and marketing

Supplied in amber glass bottles with a child resistant closure containing 25 or 50 tablets.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 39699/0043

11 November 2002

 
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