Official announcements
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…
Recall
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Veterinary Medicines
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30/11/2018
The marketing authorization holder has informed its supplied customers in a letter dated 28.11.2018 that sterility cannot be guaranteed due to an identified problem at the manufacturer. Therefore, the above mentioned batch is recalled.
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…
Recall
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Veterinary Medicines
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28/11/2018
The marketing authorization holder and the distributor have informed their supplied customers by letter dated 28.11.2018 that due to a malfunction in a production facility sterility cannot be guaranteed. Therefore, the above mentioned batch is…
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".
Safety warnings
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messages in brief
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23/11/2018
"Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" (active ingredient: valsartan) have been approved for the treatment of hypertension since August 16, 2013. In the course of…
Recall
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Medicines
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20/11/2018
The marketing authorization holder has informed its supplied customers in a letter dated November 16, 2018, that isolated impurities or contamination of the film-coated tablets have been detected, which occurred during the packaging of the…