A forwarding regarding derived measures for the blood donation system.

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 defect, but the above batch is nevertheless being recalled as a precautionary measure.

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…

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.

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 to § 94g AMG). This is done as a change according to § 24 paragraph 6 AMG; subject to notification.…

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.

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 a precautionary measure.

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 Specification results for the value of the impurity ß-methylcholine chloride in the ongoing stability studies.

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.

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 Austria enters into force. It regulates the procedure of recognition, technical cooperation as well as…