Official announcements
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…
messages in brief
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26/04/2016
Please note the changed BIC for transfers to the accounts of the Federal Office for Safety in Health Care (BASG) / AGES Medizinmarktaufsicht. (The IBAN numbers do not change). Account details for fee advances: BAWAG P.S.K. AG IBAN: AT59 6000 0000…
Recall
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Medicines
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25/04/2016
The marketing authorization holder has informed its supplied customers by letter dated April 20, 2016, that an internal quality control has detected an undercutting of the phenol content and therefore the affected batches of the Prick Test Solution…
Recall
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Medicines
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21/04/2016
The marketing authorization holder informed its supplied customers in a letter dated 19.04.2016 that an error in the filling process was detected at the manufacturer. The error results in a few vials possibly containing a too high concentration. The…
Recall
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Medicines
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21/04/2016
The marketing authorization holder has informed its supplied customers in a letter dated 20.04.2016 that the marketing authorizations of medicinal products containing fusafungin (Locabiosol / Bioparox / Locabiotal / Fusaloyos as oral spray, nasal…