Official announcements
Recall
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Medicines
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08/11/2011
The marketing authorization holder informed its supplied customers in a letter dated November 7, 2011, that crystalline particles may be present in the amino acid chamber of the two batches mentioned and that a recall is therefore being carried out…
Safety warnings
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Blood & Tissue
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04/11/2011
New confirmed case in the province of Udine.
Recall
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Medicines
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04/11/2011
In a letter dated November 3, 2011, the distributor informed all pharmacies, dentists and the wholesalers supplied that all batches of this medicinal product are being recalled due to possible microbial contamination with Burkholderia…
Safety warnings
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messages in brief
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04/11/2011
The Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen) has announced that propofol must not be used in children aged 16 years and younger for sedation in the context of intensive care. This is not a product…
Recall
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Medicines
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27/10/2011
The marketing authorization holder, in agreement with the European Medicines Agency (EMA), has informed its supplied customers by letter dated October 27, 2011, that all batches of the product Xigris are being recalled. The reason for this withdrawal…
Recall
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Medicines
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27/10/2011
In a letter dated October 27, 2011, the marketing authorization holder informed its customers that a precautionary recall is being carried out due to an increased number of suspected cases of adverse drug reactions that occurred within a short period…
Replacement
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Medicines
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24/10/2011
The marketing authorization holder informed its supplied customers in a letter dated October 24, 2011, that a precautionary recall is being carried out due to an increased number of suspected cases of adverse drug reactions that occurred within a…
messages in brief
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17/10/2011
On Oct. 11, 2011, the European Commission published revised proposals to amend Regulation (EC) No. 726/2004 and to amend Directive 2001/83/EC. The content of these proposals is to clarify the form in which companies may inform the public about…
Recall
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Medicines
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11/10/2011
The distributor has informed its supplied customers by letter dated 04.10.2011 that the affected batch has a labeling error: On the folding boxes, the expiration date is poorly legible and stamped with the wrong year (Aug. 31, 2013 instead of the…
Medicines
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10/10/2011
Ophthalmologists have informed the Federal Office for Safety in Health Care that the drug Flurekain "Croma" Eye Drops is no longer available. See related files.
