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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
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

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
Ireland

Date of first authorisation: 01 April 1979

Date of last renewal: 01 April 2009

Marketing authorization number:

PA 1691/4/2