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 |
Further inquiry note
Page last modified:
12/07/2022