The spread of the Zika virus epidemic in the Americas is likely to continue as the competent vectors Aedes aegypti and Aedes albopictus mosquitoes are widely distributed there.

The marketing authorization holder informed its supplied customers in a letter dated December 16, 2015, that a reduced active ingredient content was detected in the above batch in the course of routine stability tests, so that the shelf life until…

The marketing authorization holder and its distribution partner informed the supplied customers in a letter dated 14.12.2015 that after the introduction of a new IT system in the production facility "Stallergenes S.A." in Antony, France, difficulties…

The marketing authorization holder informed its supplied customers in a letter dated December 4, 2015, that a precautionary recall of the batch R09199 will be carried out due to two complaints, in which an instruction leaflet of another product in…

As of 1st January 2016 it will be mandatory for companies submitting applications for European and National Procedures (human and veterinary) to use the electronic application form (eAF). Please find further information at…

A re-examination of the safety and efficacy of human papillomavirus vaccines (HPV vaccines) has been completed. After evaluation of the current data by the Pharmacovigilance Risk Assessment Committee (PRAC), no causal association between the HPV…

The Federal Office for Safety in Health Care has been informed by the Irish authorities that due to faulty hemoglobin measurements caused by the analyzer "haemospect" of the manufacturer MBR Optical Systems GmbH & Co. KG, in at least two cases serious adverse reactions have occurred in the course of blood donation.

The marketing authorization holder has informed its supplied customers in a letter dated 17.11.2015 that the above mentioned batch has a blue instead of green "flip-off" cap. To avoid confusion with "Propofol ratiopharm 10 mg/ml Emulsion for…

The marketing authorization holder informed its supplied customers in a letter dated October 29, 2015, that individual bags of the batches listed above may be affected by minor deviations in the content of the active ingredient ornithine aspartate.

The Federal Office for Public Health Safety has been informed by the Greek authorities that two additional confirmed malaria cases have been recorded in Greece. No travel activity of the ill persons is known. The affected area is: Marathon (Ostattika).