Official announcements
Safety warnings
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messages in brief
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01/03/2012
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…
Replacement
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Medicines
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01/03/2012
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…
Safety warnings
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Blood & Tissue
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27/02/2012
Various products are being recalled due to various safety risks.
messages in brief
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24/02/2012
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…
Safety warnings
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messages in brief
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17/02/2012
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…
Recall
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Medicines
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01/02/2012
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…
Recall
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Veterinary Medicines
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23/12/2011
The marketing authorization holder has informed its supplied customers by telephone that the above batch was delivered with Dutch labeling.
Recall
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Medicines
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22/12/2011
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…
Recall
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Medicines
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22/12/2011
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…
Replacement
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Medicines
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14/12/2011
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…
