The distribution company has informed its supplied customers in a letter dated December 16, 2014, that in individual cases a dosage inaccuracy (slight underdosing) has been detected in dosing pumps in the prepackages of Ebixa5 mg/pump hub, 50 ml…

An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious deficiencies in the conduct of bioequivalence studies for the approval of generic drugs. There is suspicion…

An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious deficiencies in the conduct of bioequivalence studies for the approval of generic drugs. There is suspicion…

The marketing authorization holder informed its customers supplied with the product in a letter dated December 2, 2014, that all batches marketed had been reviewed because deviations had been identified in stability tests. For Austria, these tests…

As previously announced, the following e-mail addresses spc@ages.at and mrp-spc@ages.at are deactivated on 31.01.2014. Austrian "Summaries of Product Characteristics", "Labellings" and "Patient Information Leaflets" should now be submitted via PHAROS…

Austria has been informed by the Italian Medicines Agency (AIFA) of a precautionary suspension of two batches (142701 and 143301) of the influenza vaccine Fluad. The reason for the suspension is the occurrence of serious adverse events that have been…

The distributor has informed its supplied customers in a letter dated 19.11.2014 that there is a possibility of crystallization (particle formation) in the injection solution of the above batch. The crystals observed are probably precipitated…

The Federal Office for Public Health Safety has been informed by the Portuguese authority that an outbreak of Legionnaires' disease(legionellosis) has been recorded in Portugal.

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.