Saroten
Recall
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Medicines
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25/01/2018
The marketing authorization holder informed its supplied customers in a letter dated January 23, 2018, that "Saroten 10mg Film-Coated Tablets" was placed on the market with an incorrect dosage information for the treatment of depressive disorders (episodes of major depression) in the package leaflet. Therefore, the two batches placed on the market in Austria are being recalled.
| Name of the medicinal product | Saroten 10 mg - Filmtabletten |
|---|---|
| Marketing authorisation number(s) | 11734 |
| Marketing authorisation holder | Lundbeck Austria GmbH |
| Batch number(s) | 2554243 und 2558495 |
| Classification of the recall | 2 |
| BASG reference number | INS-640.001-2378 |
Further inquiry note
Page last modified:
12/07/2022