Official announcements
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:…
messages in brief
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20/11/2012
The "Guideline on good pharmacovigilance practices", Module VI obliges marketing authorization holders, among other things, to monitor the local medical press. Publications relating to any adverse drug reactions are to be identified and fed into the…
messages in brief
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16/11/2012
In order to achieve the highest possible level of health protection, very high quality requirements are placed on the manufacture of medicinal products. As a result, only drugs whose quality, efficacy and safety are guaranteed are released for…
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.
messages in brief
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23/10/2012
Unless marketing authorization holders have made use of the legal provision (Section 94 c (10) of the Austrian Medicines Act) and submitted the required renewal documents for a specific medicinal product to AGES Medizinmarktaufsicht by June 30, 2012,…
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…
messages in brief
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05/10/2012
The BMG, BMI, BMF and BASG participated in this year's action week. The operation took place this year from 25.09. to 02.10.2012. In total, more than 100 countries worldwide participated in the organized action. The aim was to simultaneously and in a…