Official announcements
Safety warnings
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Blood & Tissue
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30/08/2012
Occurrence of new diseases in the districts of Ialomita, Giurgi as well as city of Bucharest.
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,…