Official announcements
Recall
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Medicines
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12/11/2013
Due to a possible quality defect, the companies Sigma-Tau Arzneimittel GmbH and Sigma-Tau Rare Diseases S.A. have decided to recall the above mentioned batches of Oncaspar® Injection Solution.Both companies have been informed by the manufacturer of…
Recall
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Medicines
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11/11/2013
Due to a technical defect, there is a possibility in a small number of Jext epinephrine auto-injectors that the epinephrine is not correctly applied to the muscle when the auto-injector is triggered.
Recall
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Medicines
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08/11/2013
In a small number (0.04% corresponds to 4/10,000) of Jext® pre-filled pens, the adrenaline injection may not be carried out in case of need due to a technical defect. The affected batches will therefore be replaced immediately. To ensure immediate…
Replacement
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Medicines
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25/10/2013
Due to a manufacturing problem during the filling of the cartridges, individual products of the above mentioned batches of "NovoMix® 30 FLexPen®" may have an insulin content that is too high or too low. According to information from the Danish…
Recall
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Medicines
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14/10/2013
The marketing authorization holder has informed its supplied customers in a letter dated 11.10.2013 that complaints have arisen describing the disintegration of the pen after repeated use. Since the pen can no longer be used after this, a…
Recall
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Medicines
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09/10/2013
On October 8, 2013, the marketing authorization holder informed its customers that injection vials may have an externally invisible defect under the crimp cap due to the capping machine and that product leakage may occur when the vial is shaken.…
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…
