Official announcements
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…
Recall
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Medicines
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05/07/2018
The marketing authorization holder has informed its supplied customers in a letter dated July 4, 2018, that the active ingredient valsartan may contain a genotoxic impurity with carcinogenic potential.Based on this information from the active…
Recall
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Medicines
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05/07/2018
The marketing authorization holder has informed its supplied customers in a letter dated 04.07.2018 that the active ingredient Valsartan may contain a genotoxic impurity with carcinogenic potential. Based on this information from the active…
Recall
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Medicines
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05/07/2018
The marketing authorization holder has informed its supplied customers in a letter dated 05.07.2018 that an impurity was detected during the review at the active ingredient level. This impurity is classified as potentially carcinogenic. Therefore, a…
Recall
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Medicines
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05/07/2018
In a letter dated July 5, 2018, the marketing authorization holder informed its customers that the active ingredient manufacturer had detected the production-related impurity N-nitrosodimethylamine (NDMA) in the active ingredient valsartan.…
Recall
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Medicines
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05/07/2018
The marketing authorization holder has informed its customers in a letter dated December 31, 2009, that a production-related impurity has arisen at the active ingredient manufacturer during a synthesis step. This impurity is N-nitrosodimethylamine…
Recall
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Medicines
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05/07/2018
The marketing authorization holder informed its supplied customers in a letter dated December 31, 2009, that a production-related impurity occurred during a synthesis step at the active ingredient manufacturer's. The impurity is…
messages in brief
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29/06/2018
The Federal Office for Safety in Health Care (BASG) was obligated within the framework of a conciliation procedure pursuant to Section 14 of the Federal Disability Equality Act (Bundes-Behindertengleichstellungsgesetz) to request the holders of…
messages in brief
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26/06/2018
The European Medicines Agency ( EMA) held the public consultation on the impact of potential adverse reactions to fluoroquinolones, a group of antibiotics commonly prescribed in the European Union (EU) (such as ciprofloxacin, ofloxacin, etc.) on June…
