Official announcements
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…
Recall
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Medicines
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04/06/2012
The distribution company has informed its supplied customers in a letter dated 01.06.2012 that there is a potential problem with the dispensing time and dispensing volume after the autoinjector has been triggered. This problem has arisen during the…
messages in brief
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01/06/2012
As part of its transparency policy, the EMA has made data on adverse reaction reports publicly available at www.adrreports.eu since May 31, 2012. This website provides access to aggregated data on adverse drug reactions submitted by national…
messages in brief
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09/05/2012
On this occasion, the minister reminded the audience that many countries in Europe are cutting back on health care, and sometimes health care facilities are being dismantled. "It is different in Austria: the federal government has clearly stated that…
messages in brief
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26/04/2012
Around 30 girls between the ages of ten and 16 learned more about the assessment and control of medicines on today's Girl's Day. They were able to actively and passively deal with the challenges of drug control at four stations. The focus was on the…
messages in brief
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25/04/2012
The increasing complexity of the legal materials AMG and MPG, in particular the areas of clinical testing, medical devices in general, in vitro diagnostics, etc., increasingly lead to ambiguities in the implementation of research projects. In order…
Recall
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Medicines
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05/04/2012
The distributor has informed its supplied customers in a letter dated April 5, 2012, that the sterility of the batches listed above can no longer be guaranteed and therefore a recall is being carried out as a precautionary measure.
messages in brief
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02/04/2012
We would like to point out that the deadline set in accordance with Section 94c(10) of the Austrian Medicines Act, Federal Law Gazette No. 185/1983, as amended, for the submission of documents relating to an extension of the marketing authorization…
Recall
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Medicines
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02/04/2012
The marketing authorization holder has informed its supplied customers in a letter dated April 2, 2012, that a microbiological contamination has been detected at the manufacturer during a routine media filling in the production line for ViaSpan and…
Recall
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Medicines
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02/04/2012
The marketing authorization holder has informed its supplied customers by letter dated April 02, 2012, that an internal stability test after 15 months of storage has revealed the occurrence of visual particles. The recall affects all dose forms of…