Official announcements
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Recall
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Medicines
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22/01/2013
The marketing authorization holder has informed its supplied customers that preliminary results from the HPS2-THRIVE study (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) failed to show any additional benefit of…
Replacement
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Medicines
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20/12/2012
The marketing authorization holder informed its supplied customers in a letter dated Dec. 20, 2012, that the batch would be replaced due to unusual discoloration after reconstitution.
Replacement
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Medicines
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19/12/2012
The distributor has informed its supplied customers that the above batch was intended for Germany or was placed on the market in Austria in German presentation and thus an exchange for Austrian goods will be carried out.
Recall
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Medicines
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04/12/2012
In a letter dated November 29, 2012, the marketing authorization holder informed the physicians concerned that the shelf life of the physician samples with the batch number 865356 had already expired when they were dispensed (expiration date:…
Replacement
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Medicines
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14/11/2012
The distributor informed its supplied customers in a letter dated November 14, 2012, that a deviation in the manufacturing process, which was identified during an internal audit, may result in a reduced efficacy of the product. The potential…
Safety warnings
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Medicines
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09/11/2012
The batches of Fluad and Sandovac influenza vaccines that were temporarily suspended two weeks ago due to a suspected quality defect (white particles in the bulk vaccine) were re-released on Nov. 9, 2012.
Recall
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Medicines
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29/10/2012
The marketing authorization holder informed its supplied customers in a letter dated October 24, 2012, that there is a possible pyrogen contamination in the two batches listed above.
Recall
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Medicines
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16/10/2012
The marketing authorization holder, in consultation with the French authority, informed its supplied customers by letter dated 10/10/2012 that batch C079 is being recalled because it has a different volume/activity indication on the bottle label…
Recall
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Medicines
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25/09/2012
Sanofi Pasteur MSD GmbH has informed its supplied customers in a letter dated 24.09.2012 that a voluntary recall is being carried out for the above-mentioned batches due to a possibly too low antigen content.
Recall
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Medicines
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05/09/2012
The parallel distributor, HAEMATO PHARM AG; has informed its supplied customers by letter dated 5.9.2012 that the batches placed on the market by him are recalled, because tablets were found which are light blue and have "GILEAD" as tablet embossing.…
