Official announcements
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…
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…
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…
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,…
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…
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…
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.
messages in brief
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24/02/2012
The European Medicines Agency (EMA) has published a first tranche of modules of the Good Vigilance Practice (GVP) guide for public comment. In detail, these are the following seven chapters, each covering one of the main aspects of the drug safety…
Safety warnings
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messages in brief
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17/02/2012
The preparations Xenical and alli (active ingredient: orlistat) have been approved throughout Europe since 1998 and 2007, respectively, for weight reduction in adults who are overweight (body mass index BMI > = 28 kg/m2 in conjunction with a slightly…
