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ALKERAN (2014)

Active ingredients: Melphalan

Product Name and Form

Alkeran 2 mg Film-coated Tablets.

Pharmaceutical form

Film-coated tablet

White, film-coated round tablet engraved ‘GXEH3’ on one side and an ‘A’ on the other.

Qualitative and Quantitative Composition

Each tablet contains 2 mg melphalan.

For a full list of excipients see section 6.1.

Chemical substance

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
Colloidal anhydrous silica
Magnesium stearate

Tablet film-coating:

Titanium Dioxide

Pack sizes and Marketing

Alkeran Tablets are supplied in amber glass bottles of 25 or 50 tablets with a child-resistant closure.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

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

Date of first authorisation: 01 April 1979

Date of last renewal: 01 April 2009

Marketing authorization number:

PA 1691/4/2