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 recall2
BASG reference number INS-640.001-0002

Further inquiry note