Official announcements
Safety warnings
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Blood & Tissue
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04/12/2013
All preventive measures for WNV transmission halted. Those entering the country from the Americas and Canada will continue to be barred from donating for 28 days.
Replacement
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Medicines
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20/11/2013
The marketing authorization holder informed its supplied customers in a letter dated November 20, 2013, that the above-mentioned batches would be recalled from the market because values for the parameter particle size outside the approved…
Medicines
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19/11/2013
The company responsible for distribution, sigma-tau ArzneimittelGmbH, 40212 Düsseldorf, Germany, informed its supplied customers on November 15, 2013, that individual containers of the above-mentioned batches may have fine cracks that may lead to…
Recall
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Medicines
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12/11/2013
Due to a possible quality defect, the companies Sigma-Tau Arzneimittel GmbH and Sigma-Tau Rare Diseases S.A. have decided to recall the above mentioned batches of Oncaspar® Injection Solution.Both companies have been informed by the manufacturer of…
Recall
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Medicines
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11/11/2013
Due to a technical defect, there is a possibility in a small number of Jext epinephrine auto-injectors that the epinephrine is not correctly applied to the muscle when the auto-injector is triggered.
Recall
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Medicines
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08/11/2013
In a small number (0.04% corresponds to 4/10,000) of Jext® pre-filled pens, the adrenaline injection may not be carried out in case of need due to a technical defect. The affected batches will therefore be replaced immediately. To ensure immediate…
Replacement
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Medicines
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25/10/2013
Due to a manufacturing problem during the filling of the cartridges, individual products of the above mentioned batches of "NovoMix® 30 FLexPen®" may have an insulin content that is too high or too low. According to information from the Danish…
Recall
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Medicines
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14/10/2013
The marketing authorization holder has informed its supplied customers in a letter dated 11.10.2013 that complaints have arisen describing the disintegration of the pen after repeated use. Since the pen can no longer be used after this, a…
Safety warnings
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Blood & Tissue
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11/10/2013
Several regions are affected by WNV infections.
Safety warnings
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Blood & Tissue
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11/10/2013
NAT testing was implemented in the Nestos and Kavala regions. A total of 11 cases documented.