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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Safety warnings
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Medicines
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14/02/2019
During the transitional phase, strict limits are already in place for these impurities.
24/01/2019
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der dänischen Behörde mitgeteilt, dass sie von der dänischen Gewebebank Cryos International ApS (DK257551) über eine weitere Erkrankung eines Kindes, welches mit dem Samen des Spenders KELD gezeugt wurde, informiert wurde. Bei dem Spender KELD handelt es sich um einen seit 2018 durch Cryos gesperrten Spender (s. BASG Aussendung INS-630140-0003-125); es besteht jedoch die Möglichkeit, dass sich noch Spenden dieses Spenders in Umlauf befinden.
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22/01/2019
Das Bundesamt für Sicherheit im Gesundheitswesen (BASG) weist mit diesem Schreiben auf eine mögliche Gefährdung durch das Produkt „Raindrop Near Vision Inlay“ des Herstellers ReVision Optics hin.
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Safety warnings
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Medical devices
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22/01/2019
The product "Raindrop Near Vision Inlay" is a medical device for the treatment of presbyopia.
(presbyopia). It is implanted into the cornea of an eye and causes a change in the shape of the cornea.
Cornea, which is intended to improve sharp near vision.
messages in brief
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22/01/2019
A team from the Austrian Federal Office for Safety in Health Care (BASG) was a guest at the Paul Ehrlich Institute (PEI) on Jan. 14, 2019. The aim was to cooperate more closely in the future in the regulation of medicinal products for the diagnosis…
Safety warnings
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Medicines
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21/12/2018
No acute danger, all packages available in Austria have already been recalled by BASG.
21/12/2018
The fees valid on the date of application at BASG after 01.01.2019.
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Safety warnings
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messages in brief
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21/12/2018
Situation in Austria The Federal Office for Safety in Health Care (BASG) has received information that several packages of the drug "ALIMTA 500 mg Powder for the Preparation of a Concentrate for the Preparation of an Infusion Solution", for which…
Enforcement
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19/12/2018
Supposed natural products turn out to be counterfeit drugs.
messages in brief
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19/12/2018
The procedure for declaring duties for the year 2018 will change fundamentally as of 01.01.2019. As of this date, the self-declaration must be submitted and processed electronically via the web form at the Federal Office for Safety in Health Care.…