The distribution partner "sanofi-aventis GmbH" informed its supplied customers in a letter dated 04.07.2013 that the retained samples of the above batch showed deviations. After a storage time of 26 months, aggregates above the permissible limit of 5% were detected. As the batch is still within the period of 36 months, a recall was carried out.

Ergot derivatives (various preparations)

The marketing authorization holder informed its supplied customers in a letter dated 17.06.2013 that a decrease in gentamicin content was observed in a batch of Soligental after 14 months of use (85.1%; specification: 95-105%) and that all batches of the product are therefore being recalled as a precautionary measure until the cause of the problem…

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.