Official announcements
Enforcement
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19/12/2018
Supposed natural products turn out to be counterfeit drugs.
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,…
Safety warnings
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Blood & Tissue
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10/12/2018
The Federal Office for Safety in Health Care was notified by the DanishDanish authority that this from the Danish tissue bank Cryos International (DK257551) about the disease of the donor with the donor ID QADIR was.In the course of DNA analysis of…
Safety warnings
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Blood & Tissue
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10/12/2018
The Federal Office for Safety in Health Care was informed by the Danish authority that it was informed by the Danish tissue bank Cryos International (DK257551) about the disease of a child conceived with the semen of the sperm donor MITTO.
In the report of the disease, a 5-year-old child was diagnosed with autism.
Enforcement
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06/12/2018
In the past, "Poppers" have been defined as functional drugs by the Federal Office for Safety in Health Care (BASG). This classification was also confirmed in 2014 by a ruling of the Administrative Court (see below), whereby the provisions of the Medicines Act applied to the marketing of "Poppers". By a later decision of the European Court of Justice (ECJ, see below) from the same year, the classification of "Poppers" as functional drugs was revoked and is therefore no longer applicable.
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…