Official announcements
Recall
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Medicines
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22/03/2012
The marketing authorization holder has informed its supplied customers in a letter dated March 22, 2012, that glass splinters were found in the product vials during routine quality control. Therefore, the above mentioned batches are recalled in Austria as a precautionary measure.
Replacement
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Medicines
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20/03/2012
The distribution company Novartis Pharma GmbH has informed its supplied customers in a letter dated March 19, 2012, that due to water ingress in the manufacturer's warehouse, a batch of the injection syringes included in the Rabipur vaccine kit has become moist. Due to this moisture on the primary packaging of the enclosed application syringes, the…
Recall
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Medicines
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15/03/2012
The marketing authorization holder informed its supplied customers in a letter dated March 15, 2012, that a degradation product of the active ingredient cinchocaine hydrochloride exceeded the specification limit during the period of use and that a recall must therefore be carried out.
Safety warnings
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messages in brief
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12/03/2012
Methotrexate (MTX) is used to treat severe forms of psoriasis, autoimmune diseases (e.g., rheumatoid arthritis), and various tumor diseases. It is strictly available only on prescription. As a so-called "antimetabolite", the active ingredient methotrexate inhibits the formation of certain building blocks of the DNA of the cell nucleus and thus…
Recall
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Medicines
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09/03/2012
The marketing authorization holder has informed its supplied customers in a letter dated March 2, 2012, that the packages of the batches listed above contain a non-updated package insert. Since e.g. changes of the side effect profile as well as a new indication for use are missing, the affected batches will be recalled from the market.
messages in brief
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05/03/2012
The BASG / AGES Medical Market Inspectorate became aware that pharmaceutical companies were contacted by telephone in the name of AGES, or by persons claiming to be AGES employees, in order to request personal or company-related data. In this regard, we would like to inform you that we do not request personal or company-related data by telephone,…
Safety warnings
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messages in brief
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01/03/2012
As early as April 2010, the Federal Office for Safety in Health Care was informed about potential problems with the use of metal-on-metal hip implants. The Federal Office for Safety in Health Care assessed the risk situation for Austrian patients. As early as May 2010, the most important manufacturers operating in Austria as well as the responsible…
Replacement
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Medicines
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01/03/2012
The marketing authorization holder informed its supplied customers by letter dated 01.03.2012 that the above batch was mistakenly delivered in sachets with the label "Dr. Kottas Husten-Bronchialtee". Both the outer packaging and the thread label show the correct labeling.
Safety warnings
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Blood & Tissue
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27/02/2012
Various products are being recalled due to various safety risks.