Official announcements
Recall
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Medicines
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24/05/2013
The marketing authorization holder has informed its supplied customers in a letter dated 24.05.2013 that particles were observed in some vials. For this reason, the above mentioned batches are recalled as a precautionary measure.
Recall
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Medicines
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23/05/2013
During a routine test, leaks in the area of the predetermined breaking point at the neck of an amber glass ampoule of the size 1 ml were discovered in a product batch that has not yet been released, which are due to a material defect in the glass.…
Safety warnings
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messages in brief
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18/04/2013
Methotrexate (various preparations)
messages in brief
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18/04/2013
As of 01.07.2013, the transmission of Austrian product information texts is to take place via the eService "Marketing Authorization and Lifecycle Drug Specialties ". The e-mail address spc@ages.at will no longer be available as of 31.01.2014. With…
Recall
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Medicines
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18/04/2013
The marketing authorization holder informed its customers in a letter dated April 18, 2013, that due to a technical defect during production, isolated particles were observed in the prefilled syringes. In the course of a 100% inspection, prefilled…
Recall
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Medicines
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19/03/2013
The marketing authorization holder has informed its supplied customers and medical home pharmacies that a microbiological contamination has been detected in a batch of the drug "Magnesium Verla i.v./i.m. Injection Solution" from Verla-Pharm…
messages in brief
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14/02/2013
If there are major differences in the measurement of pharmacokinetic parameters, such as the AUC or Cmax, after repeated administration of the identical drug, it is reasonable to suspect that the specific product or the active ingredient itself could…
Recall
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Medicines
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31/01/2013
The distributor informed its supplied customers that during stability tests after a storage period of more than two years the specifications of the product could not be met. An impurity - "Desloratadine Citric Amide" - was detected. As the batches on…
Safety warnings
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messages in brief
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29/01/2013
Combined oral contraceptives (COCs) are divided into four generations depending on the type of progestogen they contain. The European Medicines Agency (EMA) is evaluating the need for a change in the indication of third- and fourth-generation…
Recall
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Medicines
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22/01/2013
The marketing authorization holder has informed its supplied customers that preliminary results from the HPS2-THRIVE study (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) failed to show any additional benefit of…