Official announcements
messages in brief
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07/10/2013
Policy 0070 on publication and access to clinical-trial data
messages in brief
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07/10/2013
New management of AGES Medical Market Surveillance
messages in brief
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03/10/2013
The European Union has introduced a new labeling for medicinal products that are subject to particularly close monitoring. These medicines are identified in the package leaflet by a black triangle ▼ standing on its tip with the words: "This medicinal…
Replacement
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Medicines
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02/10/2013
During a routine quality check, a small number of prefilled syringes were found to contain particles consisting mainly of cellulose fibers. The voluntary exchange only affects investigational products with the above batch numbers that were marketed…
messages in brief
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01/10/2013
Many medicinal products, when stored appropriately, remain in compliance with their specifications for much longer than can be expected on the basis of their expiration date. If you want to use such stocks of medicinal products safely and…
Recall
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Medicines
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17/09/2013
The marketing authorization holder has informed its supplied customers in a letter dated 13.09.2013 that investigations have shown that the optimal efficacy of batch 15159721 cannot be guaranteed over the entire shelf life and therefore a…
Replacement
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Medicines
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22/08/2013
The marketing authorization holder informed its supplied customers in a letter dated August 22, 2013, that visible particles were detected in some vials and that a recall of the two affected batches will therefore be carried out.
Recall
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Medicines
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06/08/2013
B. Braun Austria Ges.m.b.H. has informed its supplied customers in a letter dated August 5, 2013, that a customer complaint has informed the marketing authorization holder about a leaking Ecoflac plus infusion container in batch 13103411. Since it…
Safety warnings
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messages in brief
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26/07/2013
Metoclopramide-containing medicinal products are approved in a number of Member States in various indications, including nausea and vomiting (for example, after chemotherapy or radiotherapy, surgery, or for migraine) and gastrointestinal motility…
messages in brief
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25/07/2013
Please note the new account number of the Federal Office for Safety in Health Care (BASG) / AGES Medizinmarktaufsicht: BAWAG P.S.K. AG IBAN: AT59 6000 0000 9605 1496 BIC: OPSKATWW DVR: 2112611 Inquiries: E-mail: qmgt@ages.at