As early as April 2010, the Federal Office for Safety in Health Care was informed about potential problems with the use of metal-on-metal hip implants. The Federal Office for Safety in Health Care assessed the risk situation for Austrian patients. As…

The marketing authorization holder informed its supplied customers by letter dated 01.03.2012 that the above batch was mistakenly delivered in sachets with the label "Dr. Kottas Husten-Bronchialtee". Both the outer packaging and the thread label show…

The European Medicines Agency (EMA) has published a first tranche of modules of the Good Vigilance Practice (GVP) guide for public comment. In detail, these are the following seven chapters, each covering one of the main aspects of the drug safety…

The preparations Xenical and alli (active ingredient: orlistat) have been approved throughout Europe since 1998 and 2007, respectively, for weight reduction in adults who are overweight (body mass index BMI > = 28 kg/m2 in conjunction with a slightly…

The marketing authorization holder has informed its supplied customers in a letter dated 26.01.2012 that crystalline particles may be present in the amino acid chamber of the batches listed below and that a recall is therefore being carried out as a…

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…

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…