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).

The marketing authorization holder has informed its supplied customers in a letter dated October 22, 2015, that the stability of "Bravelle 75 I.U. Powder and Solvent for Solution for Injection" cannot be safely guaranteed until the stated expiry date…

The marketing authorization holder informed its supplied customers in a letter dated October 23, 2015, that a microbiological contamination was detected in the course of the inspection of reserve samples and that a recall of the above batch will…

The Federal Agency informs about recommendations of the Committee for Risk Assessment and Pharmacovigilance (PRAC, BASG initial notification 13.3.2015) and the subsequent decision within the European risk assessment procedure according to Article 31…

The Federal Office for Public Health Safety has been informed by the French authority that the first human WNV infection has been recorded in France. There was no travel activity within 3 weeks before the onset of symptoms. The affected area is Nîmes, Gard department (southern France).