Occurrence of a confirmed case in the province of Bologna/Ferrara.

The following quality defect has been identified in the drug product Ionsys (Fentanyl) 40 microgram per dose iontophoretic transdermal system: A defect in the IONSYS systems may potentially cause the system to self-activate. See related files.

Exchange of unbuffered and weakly buffered infusion solutions. See associated files.

Information to ensure the safety of Neupro. See related files.

Communication from the Federal Office for Safety in Health Care on Gardasil. You related file.

Information on the suspension of marketing of parenterally administrable drug products containing aprotinin. See related files.

Information on market withdrawal of Clobutinol-containing drugs (Silomat®) up to and including patient level. See related files.

Information on processing open registration and amendment requests submitted prior to Jan. 1, 2006. See related file.

According to eSubmission-Roadmap purely national variation and renewal applications have to be submitted mandatorily in eCTD/VNeeS format after January 1, 2019. Please find further information at https://www.basg.gv.at/en/eservices/ectdvnees/ .

As pubished an 29.06.2018 the Federal Office for Safety in Health Care (BASG), was obliged in an arbitration process according to § 14 of the Federal Disability Equality Act (BGStG) to request Holders of a Marketing…