The epidemic of Ebola virus disease (EVD) in West Africa in 2014 has increased the risk of Ebola virus transmissionvia donated blood and blood components, cells, tissues and organs(substances of human origin -SoHO).

The marketing authorization holder informed its supplied customers by letter dated April 24, 2014, that due to the implementing decision C(2013)9846 in the context of the European risk assessment procedure according to Article 31 of Directive…

The marketing authorization holder informed its supplied customers by letter dated April 28, 2014, that due to the implementing decision C (2013)9846 in the context of the European risk assessment procedure according to Article 31 of Directive…

The marketing authorization holder informed its supplied customers by letter dated April 28, 2014, that due to the implementing decision C(2013)9846 in the context of the European risk assessment procedure according to Article 31 Directive…

Questions and answers about the stolen vials of Herceptin and other affected products

Questions and answers about the stolen vials of Herceptin and other affected products

The distribution company informed its supplied customers on April 18, 2014 and asked for a stock check of the affected batches.

The parallel distributor has informed its supplied customers in a letter dated 18.04.2014 that Herceptin in Italian presentation has been adulterated and introduced into the legal distribution chain. Therefore, a recall of the above mentioned Italian…

Situation Austria: currently only parallel marketed Italian Herceptin and Alimta are affected (as of 18.4.2014). The drug Herceptin is approved throughout Europe for the treatment of early breast cancer, metastatic breast cancer and metastatic…

Update from the European Medicines Agency on stolen vials of Herceptin and other affected products