In a letter dated October 8, 2014, the distribution company informed its supplied customers that there is a possibility of crystals forming if the enclosed diluent of batch AHZW/1 is stored at 2 to 8°C. The diluent was used for the production of this…

The Federal Office for Public Health Safety has been informed by the Hungarian authority that further cases of human WNV infection have been recorded in Hungary. The affected areas are: Városföld (Bács-Kiskun County) and District XXI (Budapest).

Gedeon Richter Austria GmbH" informed its supplied wholesalers and gynecologists in a letter dated 03.10.2014 that instabilities of the active ingredient Desogestrel were detected during periodic stability measurements, which could shorten the shelf…

The marketing authorization holder informed its supplied customers in a letter dated October 3, 2014, that the long-term stability of the two affected batches cannot be ensured and that a precautionary recall is therefore being carried out.

A document on "The risk of transmission of Ebola virus via donated blood and other substances of human origin in the EU" was sent to the Federal Office for Safety in Health Care by the European Centre for Disease Prevention and Control (ECDC).

The Federal Office for Public Health Safety has been informed by the Hungarian authority that two more cases of human WNV infection have been recorded in Hungary. The affected areas are: Méhkerék (Bék és County) and Nádudvar (Hajdú-Bihar County).

Auto-injectors containing adrenaline are used for emergency treatment of anaphylactic shock or allergic reaction (e.g. to insect stings or bites, food or drugs). The active substance in the auto-injector (pen) is adrenaline, a substance that…

The Federal Office for Public Health Safety has been informed by the Hungarian authority that the first human WNV infections have been recorded in Hungary. The affected areas are Szeged and Deszk (Csongrád County), Szajol (Jasz-Nagykun-Szolnok County), Üllö (Pest County) and districts XII and XVII of Budapest.

In addition to isolated cases of tampered Italian Herceptin distributed in parallel, tampered MabThera of Romanian origin has now emerged.

Situation EU: In addition to individual cases of manipulated, parallel distributed Italian Herceptin, manipulated, parallel distributed MabThera of Romanian origin has now occurred in Germany (as of 16.9.2014) The Paul Ehrlich Institute warns of…