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Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
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messages in brief
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26/06/2013
Please note that, with effect from 1 July 2013, product information texts should be submitted via the PHAROS eService "Marketing Authorisation & Lifecycle Management of Medicines" on https://eservices.basg.gv.at . By then, texts and documents are no…
messages in brief
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26/06/2013
As of 02.07.2013, new regulations apply to the import of active ingredients for medicinal products for human use into the European Union. As of this date, active substances for medicinal products for human use may only be imported if at least one of…
Recall
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Medicines
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23/05/2013
During a routine test, leaks in the area of the predetermined breaking point at the neck of an amber glass ampoule of the size 1 ml were discovered in a product batch that has not yet been released, which are due to a material defect in the glass.…
Safety warnings
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messages in brief
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18/04/2013
Methotrexate (various preparations)
messages in brief
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18/04/2013
As of 01.07.2013, the transmission of Austrian product information texts is to take place via the eService "Marketing Authorization and Lifecycle Drug Specialties ". The e-mail address spc@ages.at will no longer be available as of 31.01.2014. With…
messages in brief
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14/02/2013
If there are major differences in the measurement of pharmacokinetic parameters, such as the AUC or Cmax, after repeated administration of the identical drug, it is reasonable to suspect that the specific product or the active ingredient itself could…
Safety warnings
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messages in brief
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29/01/2013
Combined oral contraceptives (COCs) are divided into four generations depending on the type of progestogen they contain. The European Medicines Agency (EMA) is evaluating the need for a change in the indication of third- and fourth-generation…
messages in brief
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20/11/2012
The "Guideline on good pharmacovigilance practices", Module VI obliges marketing authorization holders, among other things, to monitor the local medical press. Publications relating to any adverse drug reactions are to be identified and fed into the…
messages in brief
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16/11/2012
In order to achieve the highest possible level of health protection, very high quality requirements are placed on the manufacture of medicinal products. As a result, only drugs whose quality, efficacy and safety are guaranteed are released for…
Safety warnings
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Medicines
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09/11/2012
The batches of Fluad and Sandovac influenza vaccines that were temporarily suspended two weeks ago due to a suspected quality defect (white particles in the bulk vaccine) were re-released on Nov. 9, 2012.