Official announcements
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…
messages in brief
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04/12/2015
As of 1st January 2016 it will be mandatory for companies submitting applications for European and National Procedures (human and veterinary) to use the electronic application form (eAF). Please find further information at…
Safety warnings
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messages in brief
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27/11/2015
A re-examination of the safety and efficacy of human papillomavirus vaccines (HPV vaccines) has been completed. After evaluation of the current data by the Pharmacovigilance Risk Assessment Committee (PRAC), no causal association between the HPV…
Safety warnings
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Blood & Tissue
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26/11/2015
The Federal Office for Safety in Health Care has been informed by the Irish authorities that due to faulty hemoglobin measurements caused by the analyzer "haemospect" of the manufacturer MBR Optical Systems GmbH & Co. KG, in at least two cases serious adverse reactions have occurred in the course of blood donation.