Official announcements
Safety warnings
|
Blood & Tissue
|
08/10/2008
Occurrence of a confirmed case in the province of Bologna/Ferrara.
Recall
|
Medicines
|
29/09/2008
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.
Replacement
|
Medicines
|
18/08/2008
Exchange of unbuffered and weakly buffered infusion solutions. See associated files.
Medicines
|
18/01/2008
Communication from the Federal Office for Safety in Health Care on Gardasil. You related file.
Recall
|
Medicines
|
06/11/2007
Information on the suspension of marketing of parenterally administrable drug products containing aprotinin. See related files.
Recall
|
Medicines
|
31/08/2007
Information on market withdrawal of Clobutinol-containing drugs (Silomat®) up to and including patient level. See related files.
Medicines
|
01/01/2006
Information on processing open registration and amendment requests submitted prior to Jan. 1, 2006. See related file.
messages in brief
|
01/01/1970
BASG-Dialogue "Quality Day" on 29 May 2018 and 13 June 2018 During this event you will hear a lot about relevant documentation in Module 3. Furthermore you have the possibility to meet the Quality Assessors and to address your questions directly to…
messages in brief
|
01/01/1970
The OMCL of the Austrian Medicines and Medical Devices Agency has due to automation of analytical methods and optimization of processes significantly increased the capacity for official control authority batch testing of plasma products and vaccines.…