Official announcements
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…
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.
Safety warnings
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messages in brief
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10/09/2012
The active ingredient desmopressin (contained in various preparations) is approved for the treatment of primary enuresis nocturna, for the treatment of vasopressin-sensitive central diabetes insipidus, and for the treatment of nocturia associated…
Safety warnings
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messages in brief
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05/09/2012
Ukrain is a medicinal product made from celandine extracts produced by the pharmaceutical company Nowicky Pharma. The drug was advertised in the EU as an alternative cancer treatment without a valid marketing authorization. In Austria, Nowicky Pharma…
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.…
messages in brief
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30/08/2012
In accordance with Section 1 (3b) of the Austrian Medicines Act, Federal Law Gazette No. 185/1983, as amended, the following official demarcation has been made in response to questions submitted to the Federal Office for Safety in Health Care with…
Replacement
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Medicines
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27/08/2012
The marketing authorization holder informed its supplied customers in a letter dated August 27, 2012, that in the course of stability tests at the manufacturer Ben Venue Laboratories, Ohio, USA, an overfill was detected in a single dry-stone ampoule…