Official announcements
Safety warnings
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Blood & Tissue
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24/03/2016
From 1 January 2007 to 23 March 2016, Zikavirus transmission was documented in a total of 61 countries and territories. Four of these countries and territories reported a Zika virus outbreak that is now over.
messages in brief
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22/03/2016
Recently, pyrrolizidine alkaloids have also been detected in herbal preparations made from plants that do not biosynthesize pyrrolizidine alkaloids. Studies suggest that contamination with weeds may be responsible. Since even very few individuals of…
messages in brief
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18/03/2016
At the European Medicines Agency (EMA) Management Board meeting in London on March 17, 2016, Christa Wirthumer-Hoche was elected Chair of the EMA Management Board for a three-year term. DI Dr. Wirthumer-Hoche is Head of AGES Medical Market…
Recall
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Medicines
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24/02/2016
Agepha Pharma has informed its customers in a letter dated 24.02.2016 about the recall of the mentioned batch for the following reason: The composition of the eye drops has been changed (addition of povidone), but the official assessment of this…
Recall
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Medicines
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28/01/2016
The company B. Braun Austria Ges.m.b.H. informed its supplied customers in a letter dated 28.01.2016 that due to customer complaints about leaking Ecoflac® plus infusion containers of the mentioned batch a precautionary recall due to possible leakage…
Safety warnings
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Blood & Tissue
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26/01/2016
A Rapid Risk Assessment from the European Centre for Disease Prevention and Control (ECDC) regarding the ZIKA virus epidemic was forwarded to the Federal Office for Safety in Health Care by the European Commission and can be found in the appendix.
Safety warnings
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Blood & Tissue
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21/01/2016
The spread of the Zika virus epidemic in the Americas is likely to continue as the competent vectors Aedes aegypti and Aedes albopictus mosquitoes are widely distributed there.
Recall
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Medicines
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18/12/2015
The marketing authorization holder informed its supplied customers in a letter dated December 16, 2015, that a reduced active ingredient content was detected in the above batch in the course of routine stability tests, so that the shelf life until…
Recall
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Medicines
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17/12/2015
The marketing authorization holder and its distribution partner informed the supplied customers in a letter dated 14.12.2015 that after the introduction of a new IT system in the production facility "Stallergenes S.A." in Antony, France, difficulties…
Recall
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Medicines
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10/12/2015
The marketing authorization holder informed its supplied customers in a letter dated December 4, 2015, that a precautionary recall of the batch R09199 will be carried out due to two complaints, in which an instruction leaflet of another product in…
