Ebixa
Replacement
|
Medicines
|
26/01/2011
The marketing authorization holder, in agreement with the European Medicines Agency (EMA), has informed the wholesalers supplied that all batches with the old product name "Ebixa 10mg/g Oral, Solution" will be recalled and replaced by goods with the new name "Ebixa 5mg/Pump Stroke, Oral Solution". The reason for this recall is possible misunderstandings in the dosage that may occur due to the change from the dropper bottle to the pump.
| Name of the medicinal product | Ebixa 10mg/g zum Einnehmen, Lösung (50g) |
|---|---|
| Marketing authorisation number(s) | EU/1/02/219/005 |
| Marketing authorisation holder | H.Lundbeck A/S, Dänemark Durchführung Austausch: Lundbeck Austria GmbH |
| Batch number(s) | Alle Chargen |
| Expiry date | 09/04/2019 |
| Classification of the recall | 2 |
| BASG reference number | INS-640.001-0002 |
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Page last modified:
12/07/2022