Official announcements
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…
messages in brief
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06/12/2011
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…
Safety warnings
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Blood & Tissue
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05/12/2011
Removal of donor selection for various provinces.
messages in brief
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30/11/2011
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…
