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11 March 2011 /Side effects and trials
Changes in EudraCT version 8
With the update of EudraCT from version 7 to version 8, several changes have been made to the underlying structure.
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04 March 2011 /Side effects and trials
EudraCT portal unavailable 3 – 10 March 2011
The EudraCT website will be unavailable from Thursday 3 March 2011 to Thursday 10 March 2011 due to the rollout of EudraCT version 8.
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01 March 2011 /Side effects and trials
Risk of death or serious side effects in newborns following exposure to antidepressants (fluoxetine and other SSRIs)
On 27 February 2011, several Danish media addressed the side effects from the antidepressant fluoxetine including death in newborns whose mothers were treated with fluoxetine.
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01 March 2011 /Side effects and trials
Consultation on the revision of the Clinical Trials Directive 2001/20/EC
The European Commission has submitted a document on the revision of the Directive 2001/20/EC on good clinical practice etc.
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18 February 2011 /Side effects and trials
Possible connection between narcolepsy and the influenza vaccine Pandemrix® requires further studies
At present, there are not sufficient data to establish whether or not there is a connection between the sleep disorder narcolepsy and the influenza vaccine Pandemrix®, so concludes the European Medicines Agency (EMA) in a press release today.
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02 February 2011 /Side effects and trials
Increased risk of narcolepsy from the influenza vaccine Pandemrix®
A study from Finland shows that the sleep disorder, narcolepsy, could be linked to the influenza vaccine Pandemrix®. In the period 2009-2010, 60 Finnish children and adolescents aged 4-19 years fell ill with narcolepsy, and 52 of them had received the Pandemrix® vaccine. Similar cases of narcolepsy from use of Pandemrix® have also been observed in Sweden and Iceland, but not elsewhere in Europe.
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25 January 2011 /Side effects and trials
EMA changes domain name 7 February 2011
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.
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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.
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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.
