Official announcements
messages in brief
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30/08/2012
In accordance with Section 1 (3b) of the Austrian Medicines Act, Federal Law Gazette No. 185/1983, as amended, the following official demarcation has been made in response to questions submitted to the Federal Office for Safety in Health Care with…
Replacement
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Medicines
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27/08/2012
The marketing authorization holder informed its supplied customers in a letter dated August 27, 2012, that in the course of stability tests at the manufacturer Ben Venue Laboratories, Ohio, USA, an overfill was detected in a single dry-stone ampoule…
Safety warnings
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Blood & Tissue
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24/08/2012
Dealing with people willing to donate from various areas of Romania.
Replacement
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Medicines
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13/08/2012
The distribution partner sanofi-aventis GmbH Austria informed its supplied customers by letter dated August 13, 2012, that aggregates above the specification limit of 5% occurred after reconstitution of reserve samples of a batch sold in the USA. As…
Safety warnings
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Blood & Tissue
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12/08/2012
Emergence of new confirmed cases in the province of Venezia.
Medicines
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08/08/2012
Misleading wording in package insert, see related file.
Medicines
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06/08/2012
Packaged finished product batches as of May 2011 contain incorrect information in the package insert, see associated file.
Veterinary Medicines
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25/07/2012
The marketing authorization holder has informed its supplied customers in a letter dated July 25, 2012, that the folding box of batch 1261105 is incorrectly labeled "For intramuscular injection", but the product is injected subcutaneously. Therefore,…
Recall
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Veterinary Medicines
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25/07/2012
The marketing authorization holder informed its supplied customers by letter dated July 12, 2012, that batches 20528D and 20532E are to be blocked immediately. The recall of these batches was initiated by letter dated 18.07.2012. The recall was…