Official announcements
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.
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…
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.…
Recall
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Medicines
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18/12/2018
The marketing authorization holder informed its supplied customers in a letter dated December 18, 2018, that follow-up inspections of the finished product revealed isolated glass defects in the area of the bottle neck. This rarely occurring,…
Recall
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Medicines
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03/12/2018
The marketing authorization holder informed its supplied customers in a letter dated December 3, 2018, that there are increased reports of side effects for the two batches 180619 and 180620, which refer to "severe burning sensation in the eye". The…
Safety warnings
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messages in brief
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30/11/2018
Action at EU level The European Medicines Agency (EMA) has scientifically reassessed the serious, disabling and potentially permanent side effects of quinolone and fluoroquinolone antibiotics taken orally, injected or inhaled. This assessment also…
messages in brief
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28/11/2018
On November 27, 2018 a big "round table" took place on the topic of availability of medicines in Austria. At the top-class event, which was organised by the Federal Office for Safety in Health Care (BASG), more than 30 representatives of the Austrian…
messages in brief
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26/11/2018
The WHO-National Control Laboratory Network for Biologicals was established to facilitate the availability of WHO pre-qualified vaccines. The WHO pre-qualification programme provides independent opinion/advice on the quality, safety and efficacy of…
Recall
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Medicines
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23/11/2018
The marketing authorization holder informed its supplied customers in a letter dated November 23, 2018, that the active ingredient manufacturer Mylan Laboratory Limited in India has detected the production-related impurity N-nitrosodiethylamine…
Safety warnings
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Medicines
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23/11/2018
Recall of certain lots of "Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" containing valsartan active ingredient manufactured by "Mylan Laboratory Limited".