Official announcements
Recall
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Medicines
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05/08/2016
The marketing authorization holder has informed its supplied customers in a letter dated August 4, 2016, that after the application of "Nutriflex Lipid special Emulsion for Infusion " of the batch 160338052 individual cases of fever and chills have…
Safety warnings
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Blood & Tissue
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03/08/2016
The Federal Office for Public Health Safety has been informed by the Italian authority that WNV NAT testing will now be carried out in the provinces of Parma (Emilia-Romagna Region) and Cremona (Lombardia Region) in addition to the regions already announced.
Recall
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Veterinary Medicines
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02/08/2016
The distribution company "Chevita Tierarzneimittel Ges.m.b.H." has informed its supplied customers with 05.07.2016 that in the course of stability tests a reduced content of active ingredient was found and therefore the affected packages of this drug…
Safety warnings
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Blood & Tissue
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26/07/2016
The Federal Office for Public Health Safety has been informed by the Italian authority that the first human WNV (neuro-invasive disease) infection has been recorded in the province of Bologna (Emilia-Romagna Region).
Recall
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Veterinary Medicines
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26/07/2016
Since the market launch of "Velactis" in March 2016, serious side effects have been reported.
the Scientific Committee for Medicinal Products for Veterinary Use of the European Medicines
Veterinary Use) of the European Medicines Agency (EMA) has decided to notify the European Commission of a
a suspension of the marketing authorization and a precautionary recall of all batches on the market.
recommended.
Recall
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Veterinary Medicines
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26/07/2016
The marketing authorization holder has informed its supplied customers that a recall of all batches of "Velactis" on the market will be carried out, as serious side effects have been reported since market launch. The Scientific Committee for…
Recall
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Medicines
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21/07/2016
The distribution company has informed its supplied customers in a letter dated 21.07.2016 that in the instructions for use of this batch the wrong daily maximum dose of ten capsules is indicated. The correct maximum is five capsules per day. This…
Safety warnings
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Veterinary Medicines
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18/07/2016
Follow-up message
Important information from the Federal Office for Safety in Health Care about the occurrence of serious adverse reactions to Velactis
Recall
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Medicines
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15/07/2016
The marketing authorization holder has informed its supplied customers in a letter dated 14.07.2016 that the title of the leaflet is incorrect. The active strength is listed as 5 mg instead of 10 mg and therefore the affected batches of "Amlodipine…
Recall
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Medicines
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14/07/2016
The distributor of the marketing authorization holder has informed the customers supplied in the period 04.05.2016 to 19.05.2016 that due to a wrong delivery of batch 117 a batch of "Dorzo-Vision 20 mg/ml Eye Drops" in the presentation of the German…