What's new
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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Searched for "active".
Safety warnings
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messages in brief
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06/12/2014
An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious deficiencies in the conduct of bioequivalence studies for the approval of generic drugs. There is suspicion…
Safety warnings
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messages in brief
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28/11/2014
Austria has been informed by the Italian Medicines Agency (AIFA) of a precautionary suspension of two batches (142701 and 143301) of the influenza vaccine Fluad. The reason for the suspension is the occurrence of serious adverse events that have been…
Recall
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Medicines
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21/10/2014
The marketing authorization holder informed its supplied customers in a letter dated October 21, 2014, that the affected finished product lot 4E915 was produced with an aciclovir active ingredient lot that does not meet the specifications regarding…
Recall
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Medicines
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08/10/2014
Gedeon Richter Austria GmbH" informed its supplied wholesalers and gynecologists in a letter dated 03.10.2014 that instabilities of the active ingredient Desogestrel were detected during periodic stability measurements, which could shorten the shelf…
Safety warnings
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messages in brief
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25/09/2014
Auto-injectors containing adrenaline are used for emergency treatment of anaphylactic shock or allergic reaction (e.g. to insect stings or bites, food or drugs). The active substance in the auto-injector (pen) is adrenaline, a substance that…
Safety warnings
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Medicines
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17/09/2014
In addition to isolated cases of tampered Italian Herceptin distributed in parallel, tampered MabThera of Romanian origin has now emerged.
Safety warnings
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messages in brief
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17/09/2014
Situation EU: In addition to individual cases of manipulated, parallel distributed Italian Herceptin, manipulated, parallel distributed MabThera of Romanian origin has now occurred in Germany (as of 16.9.2014) The Paul Ehrlich Institute warns of…
Safety warnings
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Blood & Tissue
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05/09/2014
The Federal Office for Safety in Health Care was informed that the first confirmed WNV infection was recorded in Austria in 2014.
02/09/2014
or suspension of the IMP’s MA X Changes in the manufacturing process and/or specifications of an active substance /IMP (exception: Shelf life extensions*) X Change of the reference safety information (RSI)
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messages in brief
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01/09/2014
The Federal Criminal Police Office, in cooperation with AGES, today struck a decisive blow against an international drug counterfeiting ring.