Official announcements
Replacement
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Medicines
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13/03/2014
Madaus Ges.m.b.H." has informed its supplied customers by letter dated 11.03.2014 that within the framework of ongoing stability tests, quality deviations have been detected which represent a microbiological contamination and therefore a recall will…
Replacement
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Medicines
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06/03/2014
The distributor has informed its supplied customers in a letter dated March 5, 2014, that ten batches were identified during investigations that showed an increased risk of out-of-specification (OOS) values for the parameter "polymers, aggregates and…
Recall
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Medicines
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27/02/2014
In a letter dated February 21, 2014, the distributor informed the customers it supplied that marginal manufacturing deviations had been identified, which resulted in some NiQuitin Mini lozenges deviating in physical parameters (weight, diameter,…
Recall
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Medicines
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27/02/2014
The marketing authorization holder informed its supplied customers in a letter dated February 25, 2014, that increased customer complaints have been received regarding leaks at the emoluer connection of Clear-Flex pouches. Investigations have shown a…
Recall
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Medicines
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25/02/2014
The distributor informed its supplied customers on 03.01.2014 that during the daily control of the sterility tests of the final products of batch 02-140102 a turbidity was detected and therefore a potential contamination had to be assumed.
Safety warnings
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messages in brief
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21/02/2014
European Medicines Agency recommends restriction of use of Protelos/Osseor
Replacement
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Medicines
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04/02/2014
The marketing authorization holder informed its supplied customers by letter dated February 03, 2014 that infusion bags of 0.9% NaCl 500ml Viaflo with Austrian presentation (Ch.No. 13H31E1A) were found in a carton of 0.9% NaCl 500ml Viaflo with…
Replacement
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Medicines
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03/02/2014
The marketing authorization holder informed its supplied customers in a letter dated 31.01.2014 that a quality deviation with regard to product- and process-related impurities was found in stability tests for certain batches.
Safety warnings
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messages in brief
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03/02/2014
Prescription of CHCs and importance of individual risk factors.
Safety warnings
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messages in brief
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24/01/2014
Re-evaluation with regard to higher body weight or BMI