Official announcements
Recall
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Medicines
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30/10/2015
The marketing authorization holder informed its supplied customers in a letter dated October 29, 2015, that individual bags of the batches listed above may be affected by minor deviations in the content of the active ingredient ornithine aspartate.
Recall
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Medicines
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23/10/2015
The marketing authorization holder has informed its supplied customers in a letter dated October 22, 2015, that the stability of "Bravelle 75 I.U. Powder and Solvent for Solution for Injection" cannot be safely guaranteed until the stated expiry date…
Recall
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Medicines
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23/10/2015
The marketing authorization holder informed its supplied customers in a letter dated October 23, 2015, that a microbiological contamination was detected in the course of the inspection of reserve samples and that a recall of the above batch will…
Safety warnings
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messages in brief
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22/10/2015
The Federal Agency informs about recommendations of the Committee for Risk Assessment and Pharmacovigilance (PRAC, BASG initial notification 13.3.2015) and the subsequent decision within the European risk assessment procedure according to Article 31…
Recall
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Medicines
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01/10/2015
The marketing authorization holder informed its supplied customers in a letter dated September 17, 2015, that a slight shortfall in the protein content (PNU) was detected during internal quality control and that the affected batches of the Fusarium…
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.