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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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Recall
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Medicines
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06/12/2019
The manufacturer informed its customers on 04 December, 2019, that the stated value of the active pharmaceutical ingredient content was too high.
Recall
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Medicines
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06/12/2019
The manufacturer informed its customers on 03 December, 2019, that the listed batches of active pharmaceutical ingredients are recalled as a precautionary measure due to the withdrawal of the manufacturer's certificate of the Indian original manufacturer "Mehta API Pvt. Ltd.".
messages in brief
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21/10/2019
The second round table discussing the availability of medicines in Austria took place on October 15, 2019.
Safety warnings
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Medicines
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17/09/2019
Information on NDMA contamination in ranitidine medicines and recalls
Safety warnings
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messages in brief
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17/09/2019
Measures at EU level At the request of the European Commission, the European Medicines Agency (EMA) has begun reviewing medicines containing ranitidine after investigations found contamination with N-nitrosodimethylamine (NDMA). NDMA is classified as…
Recall
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Medicines
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23/08/2019
The marketing authorisation holder informed its customers on August 23, 2019 that below mentioned batch is recalled because the content of the active substance is below specification limits.
messages in brief
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26/07/2019
Situation in Austria Imurek-50 mg Film-Coated Tablets are currently temporarily unavailable due to increased demand beyond national borders, and associated capacity constraints at the manufacturer. This information is publicly available on the…
Safety warnings
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messages in brief
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14/02/2019
During the transitional phase, strict limits are already in place for these impurities.
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.
messages in brief
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04/02/2019
The EMA published a revision of the “Guideline on the environmental risk assessment (ERA) of human medicines” on 30 November 2018. The guideline is now open for public consultation until 30 June 2019. The purpose of the ‚Guideline on Environmental…