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).

The Federal Office for Public Health Safety has been informed by the Italian authority that WNV NAT testing will now be carried out in the province of Rimini in addition to the regions already announced.

The Federal Office for Public Health Safety has been informed by the Romanian authority that additional human WNV (neuro-invasive disease) infections have been recorded in Romania. The affected areas are Amaru (Buzau County), Sf Gheorghe (Ialomita County), and Vidra (Ilfov County).

The marketing authorization holder informed its supplied customers in a letter dated September 17, 2015, that a slight shortfall in the protein content (PNU) was detected during internal quality control and that the affected batches of the Fusarium…

The Federal Office for Public Health Safety has been informed by the Greek authority that 4 confirmed malaria cases have been recorded in Greece. No travel activity of the ill persons is known. The affected areas are: Farkadona (Trikala), Evrotas (Lakonia), Theva (Viotia) as well as Tempi (Larisa).

Dear registration holder,due to a technical malfunction in the period from 20.09.2015 (15h) until 28.09.2015 (12h) an electronic transmission of adverse event reports to BASG/AGES MEA was not possible. Therefore, you did not receive an…

The Federal Office for Public Health Safety has been informed by the Romanian authorities that additional human WNV (neuro-invasive disease) infections have been recorded in Romania. The affected areas are Fierbinti (Ialomita County), Drobeta Turnu Severin (Mehedinti County), and Bucharest.