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 the time of payment. The obligation to pay the medical device levy arises for the natural or legal…

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 outside of clinical trials was prohibited by decree from the Federal Minister of Health. According to…

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 measure, all batches of Velcade manufactured at BVL are now being recalled. Velcade 3.5 mg can be…

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 precautionary measure, all batches of Busilvex manufactured at BVL are now being recalled and replaced with…

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 tablets with a fracture notch, but the tablets are actually white, round, flattened tablets with a…

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 as a precautionary measure.

New confirmed case in the province of Udine.

In a letter dated November 3, 2011, the distributor informed all pharmacies, dentists and the wholesalers supplied that all batches of this medicinal product are being recalled due to possible microbial contamination with Burkholderia cepacia/stabilis.

The Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen) has announced that propofol must not be used in children aged 16 years and younger for sedation in the context of intensive care. This is not a product warning, but a reference to the approved use. Propofol belongs to the group of drugs known as general…