Official announcements
Safety warnings
|
Medicines
|
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
|
messages in brief
|
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 defect was discovered, according to which the epinephrine solution is not or not sufficiently…
Recall
|
Medicines
|
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 development of a new variant which is not yet on the market. The potential risk is a possible reduced…
messages in brief
|
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 authorities and marketing authorization holders to the pan-European database EudraVigilance in accordance…
Recall
|
Veterinary Medicines
|
24/05/2012
The marketing authorization holder informed its supplied customers in a letter dated May 22, 2012, that visual particles resulting from precipitate formation were detected in individual batches during quality control and that a recall was therefore being implemented as a precautionary measure.
messages in brief
|
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 we want to further develop the healthcare system. Therefore, I am particularly pleased that we are…
Recall
|
Veterinary Medicines
|
07/05/2012
In a letter dated April 26, 2012, the marketing authorization holder informed its supplied customers that the active ingredient content of the above-mentioned batches could be outside the product specification at the end of the shelf life and that a recall would therefore be carried out as a precautionary measure.
messages in brief
|
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 high-performance analysis of drugs, pharmaceutical methods and the analysis of plant drugs. At the…
messages in brief
|
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 to provide appropriate support, the BASG is offering a "consultation hour" for western Austria from…
Recall
|
Medicines
|
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.