Official announcements
Medicines
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08/08/2012
Misleading wording in package insert, see related file.
Medicines
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06/08/2012
Packaged finished product batches as of May 2011 contain incorrect information in the package insert, see associated file.
Recall
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Medicines
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13/07/2012
The marketing authorization holder informed its customers by letters dated July 10 and 13, 2012, that the patient-specific batches could have an elevated protein-nitrogen content and that the manufacturer could not rule out the possibility that the…
messages in brief
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09/07/2012
The following innovations are planned throughout Europe: Risk and risk managementAll medicinal products carry known and unknown risks at the time of their authorization. The previous version of Regulation 726/2004 already takes this knowledge into…
Recall
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Medicines
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04/07/2012
The marketing authorization holder informed its supplied customers in a letter dated July 2, 2012, that quality deviations were detected in current batches during stability tests. Therefore, as a precautionary measure, the delivery will be stopped…
Recall
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Medicines
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29/06/2012
The marketing authorization holder informed its supplied customers by letter dated 28.06.2012 that the transport carton of batch A010816 is labeled with the strength "Propofol ratiopharm 10 mg/ml emulsion for injection or infusion" (500 mg/50 ml),…
Safety warnings
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messages in brief
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06/06/2012
The occurrence of venous thromboembolic events (VTE) is a rare but long-known adverse effect of combined oral contraceptives (COCs), which is explicitly mentioned in the technical and instructions for use of the preparations. Recent studies have…
Safety warnings
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Medicines
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05/06/2012
Recently, a quality defect was identified during further development of the product, according to which the epinephrine solution is not delivered or is delivered insufficiently in the event of an anaphylactic emergency.
Safety warnings
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messages in brief
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05/06/2012
Anapen (active ingredient: epinephrine) has been approved for the treatment of a state of shock (anaphylactic emergency) in some European member states, including Austria, since 2005. Recently, during the further development of the product, a quality…