The marketing authorization holder has informed its supplied customers in a letter dated December 21, 2011, that crystalline particles may be present in the amino acid chamber of the batches listed below and that a recall is therefore being carried…

In a letter dated December 12, 2011, the distribution partner informed the institutional pharmacies supplied that the marketing authorization holder was recalling those batches of "Velcade" that were produced at the manufacturer Ben Venue…

The marketing authorization holder has informed its supplied customers by letter dated 14.12.2011 that the above mentioned batches have to be recalled due to a potential contamination with particles. This problem was identified during a GMP…

This ordinance serves to implement the power to issue ordinances under Section 12a(2) of the Health and Food Safety Act. It regulates the detailed modalities of the levy, the parties obliged to pay the levy, details of the collection procedure and…

Removal of donor selection for various provinces.

The illegally sold and used drug Ukrain, which is advertised as a remedy against cancer, may not be manufactured and sold in Austria for the protection of patients. In addition, individual importation into Austria was prohibited by notice and use…

The marketing authorization holder has informed the supplied customers by letter dated November 28, 2011, that a GMP inspection of the manufacturer Ben Venue Laboratories (BVL) in Ohio/USA identified quality assurance deficiencies. As a precautionary…

The distributor has informed the supplied institutional pharmacies in a letter dated November 25, 2011, that a GMP inspection of the manufacturer Ben Venue Laboratories (BVL) in Ohio/USA has identified deficiencies in quality assurance. As a…

The marketing authorization holder informed its supplied customers in a letter dated November 14, 2011, that there was misinformation in the instructions for use regarding the appearance of the tablets: the description reads salmon-colored oval…

The marketing authorization holder informed its supplied customers in a letter dated November 7, 2011, that crystalline particles may be present in the amino acid chamber of the two batches mentioned and that a recall is therefore being carried out…