25 January 2011 /Side effects and trials
Please note that, as part of the European Medicines Agency’s domain name change from 'EMEA’ to 'EMA’, adverse reaction reporting systems will need to be updated in order to still send E2B files.
24 January 2011 /Side effects and trials
Information for doctors and dialysis patients regarding peritoneal dialysis solutions from Baxter A/S
As announced previously, there is presently an increased risk that peritoneal dialysis patients could develop aseptic peritonitis (inflammation of the peritoneum). Doctors and patients should still be alert to symptoms suggestive of aseptic peritonitis and should report any cases of aseptic peritonitis in peritoneal dialysis patients.
17 January 2011 /Side effects and trials
No acknowledgement message is currently dispatched when companies submit electronic adverse reaction reports
Since Thursday 13 January, the Danish Medicines Agency has experienced problems with dispatching acknowledgement messages (ACKs) for electronic adverse reaction reports submitted by companies. We are doing all we can to solve the problem fast so that we can send the ACKs that are awaiting.