Thioguanin "Aspen"
Replacement
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Medicines
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29/04/2011
In a letter dated April 29, 2011, the marketing authorization holder informed its customers that the two batches had to be exchanged because routine stability tests had revealed that the test values for active ingredient release and disintegrability were outside the specification.
| Name of the medicinal product | Thioguanin "Aspen“ – Tabletten / Thioguanin "GSK“ – Tabletten |
|---|---|
| Marketing authorisation number(s) | 16.354 |
| Marketing authorisation holder | Aspen Europe GmbH (vor 08/2010: GlaxoSmithKline Pharma GmbH) |
| Batch number(s) | 905066, 907324 |
| Classification of the recall | II |
| BASG reference number | INS-640.001-0108 |
Further inquiry note
Page last modified:
12/07/2022