Official announcements
messages in brief
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29/09/2015
Dear registration holder,due to a technical malfunction in the period from 20.09.2015 (15h) until 28.09.2015 (12h) an electronic transmission of adverse event reports to BASG/AGES MEA was not possible. Therefore, you did not receive an…
messages in brief
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27/08/2015
Small import" of medicinal specialities according to § 11 para. 1 Z 7 of the Austrian Medicinal Products Import ActThe Federal Office for Safety in Health Care takes the liberty to state with regard to the exceptional provision of the so-called…
Recall
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Medicines
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27/08/2015
The marketing authorization holder informed its supplied customers in a letter dated August 25, 2015, that a different number of small particles was observed in some bottles of the above-mentioned batches after preparation of the ready-to-use…
Recall
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Medicines
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24/08/2015
The marketing authorization holder has informed its supplied customers in a letter dated 21.08.2015 that the batches listed above were manufactured with an active ingredient batch that may be contaminated with particles of the manufacturing…
Recall
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Medicines
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14/07/2015
The marketing authorization holder has informed its supplied customers in a letter dated 13.07.2015 that the above batch is being recalled as a precautionary measure because an outdated package insert was enclosed.
Safety warnings
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messages in brief
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01/07/2015
The European Medicines Agency (EMA) recommends new measures to ensure the safe and successful use of epinephrine auto-injectors. Introduction of new training material Patients should always carry two auto-injectors for safety. Measures at EU level…
messages in brief
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30/06/2015
On May 12, 2015, the European Medicines Agency (EMA) announced that - in accordance with Article 27 of Regulation (EC) No. 726/2004 - starting on July 1, 2015, the search for suspected ADRs published in the scientific literature will be conducted by…
Recall
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Medicines
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30/06/2015
In a letter dated June 26, 2015, the marketing authorization holder informed its customers that ongoing stability tests have revealed values outside the specification for the degradation product ketolactam. The reason lies in a too long holding time…
messages in brief
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23/06/2015
As of June 25, Austrian pharmacies will be allowed to sell over-the-counter medicines over the Internet - BMG and BASG launch educational campaign
Recall
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Medicines
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02/06/2015
The parallel distributor has informed its supplied customers in a letter dated June 2, 2015, that the affected batch A229473D is being recalled due to a falsification of the packaging. The marketing authorization holder "Gilead Sciences International…
