The Federal Office for Safety in Health Care was informed by the Vienna Blood Transfusion Service (ÖRK) that a suspected WNV infection had been recorded in Austria.

The parallel distributor informed its supplied customers on 13.08.2014 and asked for a stock check of the affected batches, as these batches were illegally distributed from Italy and entered the legal distribution chain.

The manufacturer informed its supplied customers by letter dated July 24, 2014, that the active ingredient manufacturer "SIMS Società Italiana Medicinali Scandicci srl" was assessed by the responsible inspection authority as not GMP-compliant and…

Reassessment completed with regard to higher body weight or BMI.

The marketing authorization holder informed its supplied customers by letter dated July 15, 2014, that a loss of sterility for the Absorbable Collagen Sponge (ACS) was detected during a stability study after 24 months, so that a recall is being…

NAT testing has been implemented for various regions in Italy.

The marketing authorization holder has informed wholesalers and pharmacies in a letter dated 07.07.2014 that the duration of the above batches was printed incorrectly and therefore a replacement will be made. The runtime indicated on the labeling is…

The marketing authorization holder informed its supplied customers by letter dated July 1, 2014, that the sedacoron batch DV6862 delivered in the period from February 2014 to May 2014 exhibited increased crystallization, so that a precautionary…

The marketing authorization holder has informed its supplied customers in a letter dated 30.06.2014 that the approved specifications are not met in efficacy tests, so that the above batch is being recalled. No other batches in Austria are affected by…

Implementing regulation adopted for a common logo for online pharmacies to verify authenticity under the Falsified Medicines Directive.