Source: Health Products Regulatory Authority (IE) Revision Year: 2014 Publisher: Aspen Pharma Trading Limited 3016 Lake Drive Citywest Business Campus Dublin 24 Ireland
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. |
Each tablet contains 2 mg melphalan.
For a full list of excipients see section 6.1.
| 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 Tablet film-coating: Hypromellose |
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.
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland
PA 1691/4/2
Date of first authorisation: 01 April 1979
Date of last renewal: 01 April 2009
| Drug | Countries | |
|---|---|---|
| ALKERAN | Austria, Australia, Brazil, Canada, Estonia, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United States, South Africa |
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