Official announcements
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…
Safety warnings
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Blood & Tissue
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08/07/2016
Given the current circulation of Zika virus; the evidence of an association between Zika virus infection during pregnancy and congenital malformations of the central nervous system (CNS); the association between Zikavirus infection and Guillain–Barré Syndrome(GBS)and the risk of local vector-borne transmission in Europe during the 2016 summer season, EU/EEA Member States are recommended to consider a range of mitigation measures.
messages in brief
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27/06/2016
VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing) is a research and development project in which new, innovative tests for the quality control of human and veterinary vaccines are being developed. The primary goal of the…
Safety warnings
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Veterinary Medicines
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27/06/2016
Wichtige Information des Bundesamtes für Sicherheit im Gesundheitswesen über das Auftreten von schwerwiegenden Nebenwirkungen zu Velactis
Schwerwiegende Nebenwirkungen sind kurz nach Markteinführung von Velactis im März 2016 gemeldet worden. Die gemeldeten Symptome sind Festliegen, Hypothermie, Hypokalzämie, Funktionsstörung des Pansens, Diarrhö, periphere Durchblutungsstörungen, Ataxie, Adipsie und Ausbleiben der erwarteten Wirksamkeit. 22 Rinder sind nach der Anwendung verstorben.
Recall
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Medicines
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23/06/2016
The marketing authorization holder informed its supplied customers in a letter dated June 20, 2016, that a precautionary recall is being carried out due to the potential risk of glass particles in the vials.
messages in brief
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13/06/2016
For detailed information, please contact us and EMA .
Recall
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Medicines
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09/05/2016
The marketing authorization holder has informed its supplied customers in a letter dated 09.05.2016 that due to a technical error during production, there are residues of corrosive agents in the dry substance. Therefore, the two above mentioned…