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".
Recall
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Veterinary Medicines
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11/10/2018
The marketing authorization holder has informed its supplied customers by letter dated 09/10/2018 that an atypical trend in the level of non-specified impurities has been detected in terbinafine - one of the three active ingredients in Osurnia.…
Safety warnings
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Blood & Tissue
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24/09/2018
The Federal Office for Public Health Safety has been informed by the Italian authority that WNV has been detected in the province of Verbano-Cusio Ossola (Piedmont region) during active surveillance of target bird species.
For this reason, testing for donors of blood and blood components (in addition to the regions already notified) will be performed in this region ID WNV NAT.
01/09/2018
Diese Gebührenverordnung findet Anwendung auf alle Anbringen, die ab dem 01.09.2018 beim BASG eingegangen sind.
Referenced at:
Recall
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Medicines
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14/08/2018
The marketing authorization holder informed its supplied customers in a letter dated July 5, 2018, that a production-related impurity occurred at the active ingredient manufacturer during a synthesis step. This impurity is N-nitrosodimethylamine…
Safety warnings
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messages in brief
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03/08/2018
The European Medicines Agency (EMA) is currently conducting an investigation into the potential health effects on patients who have taken valsartan medicines containing the impurity NDMA. NDMA is an impurity found in the active ingredient valsartan,…
Safety warnings
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Medicines
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03/08/2018
Preliminary risk assessment of NDMA for patients
Recall
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Medicines
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06/07/2018
The marketing authorization holder informed its supplied customers in a letter dated 06.07.2018 that a production-related contamination of the active ingredient was detected. The substance in question is N-nitrosodimethylamine (NDMA). Therefore, a…
Recall
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Medicines
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06/07/2018
In a letter dated July 6, 2018, the marketing authorization holder informed its customers that a production-related contamination of the active ingredient has been detected. Therefore, a precautionary recall of all batches of "Valsartan Sandoz…
Safety warnings
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Medicines
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05/07/2018
No acute danger. Discontinuation of medication not recommended
Safety warnings
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messages in brief
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05/07/2018
A batch-related recall of medicines containing valsartan, the active ingredient of which was produced by the Chinese manufacturer Zhejiang Huahai Pharmaceutical, is currently taking place in the European Union. The affected drugs are used to treat…