Official announcements
messages in brief
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29/12/2010
At the end of 2010, the following deadlines will expire according to the Medicines Act BGBl Nr 185/1983 as amended: Inclusion of doping warning until 31.12.2010 All medicinal products concerned must contain the doping warning by 31.12.2010 (according…
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.
messages in brief
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01/12/2010
As of 01.12.2010, the agreement between the Republic of Austria and the Government of the Principality of Liechtenstein concerning the automatic recognition in Liechtenstein of human and veterinary medicinal products authorized or registered in…
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.
Replacement
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Medicines
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18/11/2010
The marketing authorization holder has informed its supplied customers by letter dated 18.11.2010 that due to 5 complaints about visible particles after reconstitution of the product, which occurred in two batches of this medicinal speciality, the…
messages in brief
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17/11/2010
Table 1: Product on the market and new application filed (65)*. Table 2: Product not on the market, new application filed (6)** Table 3: Product on the market, no new application filed (122)* Table 4: Product not on the market, no new application…
Recall
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Medicines
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17/11/2010
Ebewe/Sandox has initiated a voluntary recall of certain lots of ebetraxate as a precautionary measure. See related file.
