Official announcements
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…
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…
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…
messages in brief
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30/11/2011
The illegally sold and used drug Ukrain, which is advertised as a remedy against cancer, may not be manufactured and sold in Austria for the protection of patients. In addition, individual importation into Austria was prohibited by notice and use…
Safety warnings
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messages in brief
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04/11/2011
The Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen) has announced that propofol must not be used in children aged 16 years and younger for sedation in the context of intensive care. This is not a product…
messages in brief
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27/09/2011
Since 01.09.2011 the new harmonized validation criteria are in force. From now on, the validation of dossiers includes the following criteria: Pass/Fail (P/F) and Best Practice (BP). A dossier is considered valid if all Pass/Fail criteria have been…
Safety warnings
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messages in brief
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23/09/2011
The preparations Xenical and Alli Vimpat (active ingredient: orlistat) have been approved throughout Europe since 1998 and 2007, respectively, for weight reduction in adults with overweight (body mass index BMI≥28 kg/m2 in combination with a mildly…
Safety warnings
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messages in brief
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01/09/2011
Orally administered isotretinoin is highly teratogenic and strictly contraindicated in pregnancy. Reliable pregnancy prevention is therefore essential when using isotretinoin (Ciscutan®, various generics). Prescribing, dispensing and taking…
Safety warnings
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messages in brief
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01/07/2011
Ketoprofen-containing proprietary medicinal products are approved for the local symptomatic therapy of pain conditions, mainly in the field of traumatology and rheumatology. Due to reports of light-allergic reactions, the risk-benefit balance of…
messages in brief
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03/05/2011
On May 3, 2011, the Ordinance of the Federal Office for Safety in Health Care on the Electronic Transmission of Applications and Notifications (Electronic Submission Ordinance 2011 - EEVO 2011) was published in the Official Gazette of the Federal…
