Official announcements
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Safety warnings
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messages in brief
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17/04/2014
Situation Austria: currently only parallel marketed Italian Herceptin and Alimta are affected (as of 18.4.2014). The drug Herceptin is approved throughout Europe for the treatment of early breast cancer, metastatic breast cancer and metastatic…
messages in brief
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17/04/2014
Austrian "Summaries of Product Characteristics", "Labellings" and "Patient Information Leaflets" should now be submitted via PHAROS eService "Marketing Authorisation & Lifecycle Management of Medicines": https://eservices.basg.gv.at/ . If you are not…
Safety warnings
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messages in brief
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16/04/2014
European Medicines Agency warns against counterfeit Herceptin
Safety warnings
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messages in brief
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21/02/2014
European Medicines Agency recommends restriction of use of Protelos/Osseor
Safety warnings
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messages in brief
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03/02/2014
Prescription of CHCs and importance of individual risk factors.
Safety warnings
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messages in brief
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24/01/2014
Re-evaluation with regard to higher body weight or BMI
Safety warnings
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messages in brief
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20/12/2013
The preparation Eldisin 5 mg dry ampoules (active ingredient: vindesine sulfate) has been approved in Austria since March 29, 1984. Vindesine is a cytostatic drug from the group of vinca alkaloids and has proven effective primarily in combination…
messages in brief
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07/10/2013
Policy 0070 on publication and access to clinical-trial data
messages in brief
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07/10/2013
New management of AGES Medical Market Surveillance
messages in brief
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03/10/2013
The European Union has introduced a new labeling for medicinal products that are subject to particularly close monitoring. These medicines are identified in the package leaflet by a black triangle ▼ standing on its tip with the words: "This medicinal…