Official announcements
messages in brief
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30/11/2016
EU Regulation 536/2014 is expected to standardize the approval procedure for clinical trials throughout the EU from fall 2018. These are an essential part of drug development and, not least, provide objective proof of the effect and side effects of…
messages in brief
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07/11/2016
AGES Medical Market Surveillance launches a social media campaign from November 7 - 11, 2016 to increase willingness to report adverse reactions. Vienna (OTS) - In addition to positive effects, medicinal products can also have potential side effects.…
messages in brief
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02/11/2016
Legal trade in pharmaceutical specialties via the Internet was made possible in Austria in 2015 by an amendment to the Austrian Medicines Act and linked to legal requirements. Technical features on the drug provider's website enable consumers to…
Recall
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Medicines
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24/10/2016
The marketing authorization holder informed its supplied customers in a letter dated October 12, 2016, that an impurity, "lmpurity D", was detected in the course of stability tests, which in the measured concentration does not indicate any health…
Recall
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Medicines
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24/10/2016
The marketing authorization holder informed its supplied customers in a letter dated October 13, 2016, that an impurity, "lmpurity D", was detected during stability tests. In the measured concentration there is no health risk for the patients. A…
Recall
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Medicines
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18/10/2016
Gedeon Richter Plc has informed their supplied customers by letter dated 12/10/2016 that above mentioned batches of "Lisvy 60 microgram/24 hours + 13 microgram/24 hours Transdermal Patch" are recalled. Stability data for these batches indicated a…
Safety warnings
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messages in brief
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17/10/2016
Several cases of accidental overdose associated with Levetiracetam - Oral Solution have been reported throughout Europe. The majority of cases involved children between 6 months and 11 years of age. Many of these unintentional medication errors…
Recall
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Medicines
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14/10/2016
CSL Behring as distributor of the product Helixate NexGen has, in coordination with the marketing authorization holder Bayer Pharma AG, informed its supplied customers in a letter dated October 11, 2016, that the above mentioned batches of Helixate…
Recall
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Medicines
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19/09/2016
In a letter dated 19.09.2016, the marketing authorization holder informed its customers that yellow-brownish particles had been detected in the above batch and that a recall was therefore being carried out. The particles are traces of corrosion…
Recall
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Medicines
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16/09/2016
The marketing authorization holder informed its supplied customers in a letter dated 13.09.2016 that its batch of "Chlorhexidine digluconate Sage 20 mg/ml impregnated wipe" must be recalled as it is possibly microbiologically contaminated withbecause…