The outbreak of Legionnaires’ disease in Portugal with 311 cases reported as of 13 November 2014 is one of the largest in the European Union. Vila Franca de Xira is not considered a tourist destination and no case has so far been confirmed outside Portugal. Despite the magnitude of the outbreak, this event can be considered a local event. All cases were infected in Vila Franca de Xira where the outbreak is occurring.

The Federal Office for Public Health Security has been notified that four autochthonous cases of human chikungunya infection have been recorded in Montpellier, Languedoc-Roussillon Region, southern France.

The marketing authorization holder informed its supplied customers in a letter dated October 21, 2014, that the affected finished product lot 4E915 was produced with an aciclovir active ingredient lot that does not meet the specifications regarding…

The Federal Office provides information on recommendations of the Committee for Risk Assessment and Pharmacovigilance (PRAC) within the framework of the European risk assessment procedure according to Article 31 of Directive 2001/83/EC regarding the…

Status 06.09.2014: The BASG / AGES Medical Market Surveillance became aware that dubious persons were contacting by telephone in the name of AGES pharmaceutical companies, or that these persons were posing as AGES employees in order to request…

The distribution company informed its customers in a letter dated October 13, 2014, that after 3 years of storage at 30°C and 75% humidity and after 6 months of storage at 40°C and 75% humidity, increased levels of known and unknown impurities as…

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.