Official announcements
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Replacement
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Medicines
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10/02/2011
The marketing authorization holder has informed its supplied customers that results from stability data indicate a possible shortfall of the required active ingredient content by the end of the shelf life. The affected batch currently meets all…
Replacement
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Medicines
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03/02/2011
The marketing authorization holder informed its supplied customers in a letter dated February 3, 2011, that empty or almost empty prefilled syringes had been discovered in individual packages of the above batch and that the batch would therefore be…
Recall
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Medicines
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26/01/2011
The marketing authorization holder has informed its supplied customers in a letter dated January 25, 2011, that cracks have been detected in the cone of some prefilled syringes. At present, there is no indication that sterility is impaired by this…
Replacement
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Medicines
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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…
Recall
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Medicines
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05/01/2011
Two batches of the product Dianeal have been identified that may contain endotoxins. Therefore, the marketing authorization holder has decided to recall the above mentioned batches from a dialysis center supplied in Austria.
Recall
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Medicines
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23/12/2010
The marketing authorization holder has received increased adverse reactions (aseptic peritonitis) to the above batch. Therefore, Baxter Healthcare has decided to recall this batch from those dialysis centers that were supplied with this product.
Recall
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Medicines
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21/12/2010
The marketing authorization holder informed its supplied customers in a fax transmission on December 20, 2010, that due to complaints on the German market regarding the unpleasant odor of the tablets, a recall would also be carried out in Austria as…
Recall
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Medicines
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15/12/2010
The distribution partner Croma-Pharma has informed the supplied customers by letter dated December 9, 2010, that the above mentioned batches have to be recalled due to reduced stability. The affected batches show a negative trend or Out of…
Replacement
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Medicines
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13/12/2010
The marketing authorization holder informed its supplied customers in a letter dated December 13, 2010, that the affected batch exhibited significant deviations in disintegration time and friability.
Recall
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Medicines
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29/11/2010
The marketing authorization holder informed its supplied customers by letters dated October 29 and November 25, 2010, that the sterility of the products cannot be guaranteed for the batches listed above.