Official announcements
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 precautionary measure.
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 out as a precautionary measure.
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 Laboratories (BVL) in Ohio/USA, because deficiencies in quality assurance were identified during a GMP…
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 inspection of the manufacturer Ben Venue Laboratories (BVL) in Ohio/USA.
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 the time of payment. The obligation to pay the medical device levy arises for the natural or legal…
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 outside of clinical trials was prohibited by decree from the Federal Minister of Health. According to…
Recall
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Medicines
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28/11/2011
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…
Replacement
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Medicines
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25/11/2011
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…