More than 100 countries participated in this year's week of action against the illegal sale of medicines on the Internet. In total, more than nine million potentially dangerous medicines worth around 41 million US dollars were seized worldwide. Austria successfully participated for the sixth time in the global action, which took place this year…

Please note that, with effect from 1 July 2013, product information texts should be submitted via the PHAROS eService "Marketing Authorisation & Lifecycle Management of Medicines" on https://eservices.basg.gv.at . By then, texts and documents are no longer requested to be submitted via email. From 31 January 2014, the email addresses spc@ages.at…

The distributor has informed its supplied customers in a letter dated 25.06.2013 that the following errors in the product labeling occurred in these batches and therefore a withdrawal from the market will take place: For "AviPro IB H52", the bottle labels incorrectly state the application for spraying. In the case of "AviPro IB H120", the…

As of 02.07.2013, new regulations apply to the import of active ingredients for medicinal products for human use into the European Union. As of this date, active substances for medicinal products for human use may only be imported if at least one of the following conditions according to Art 46b of the Directive 2012/62/EU is fulfilled: The…

The marketing authorization holder has informed its supplied customers in a letter dated June 19, 2013, that due to a manufacturing problem and the associated risk of microbial contamination with "Sphingomonas yanoikuyae", the above mentioned batches 042265AD, 042285AD, 042304AD1 are being recalled as a precautionary measure. The information letter…

The marketing authorization holder informed its supplied customers in a letter dated June 18, 2013, that due to an individual complaint from the German market regarding a plastic ampoule leaking at the neck of the bottle, batch 12FHL21 will be replaced as a precautionary measure.

The marketing authorization holder informed its supplied customers in a letter dated June 4, 2013, that individual bottles of the batch 1112208AE of the product Vitasol AD3EC Injection Solution for Animals, package size 5 x 100 ml, had been placed on the market without a label.

The marketing authorization holder informed its supplied customers in a letter dated June 3, 2013, that in the course of stability tests after 24 months of storage, non-specification-compliant results were found for a batch of Cileste in the dissolution test of Norgestimat. All other test parameters were within your specification. As TriCilest and…

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.

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. Therefore, the marketing authorization holder recalls various injection solutions. The affected…