Official announcements
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Recall
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Medicines
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11/03/2019
The marketing authorisation holder informed its customers on March 6, 2019 that the marketing of „Tetraspan 60 mg/ml Infusionslösung“ and „Venofundin 60 mg/ml Infusionslösung“ is ceased permanently for economic reasons.
Recall
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Medicines
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21/02/2019
The marketing authorisation holder informed its customers on February 19, 2019 that the marketing authorisation of „Vantobra 170 mg Lösung für einen Vernebler“ will be withdrawn.
Recall
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Medicines
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15/02/2019
The parallel distributor „HAEMATO PHARM GmbH“ informed its customers on February 14, 2019 that the supply chain is not fully documented and GDP-guidelines are not met.
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.
Recall
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Medicines
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28/12/2018
The marketing authorization holder has informed its supplied customers in a letter dated December 27, 2018, that the above-mentioned batch occasionally shows a yellow coloration of the infusion solution concentrate outside the approved color…
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.
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…
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".