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03 March 2011 /Authorisation and supervision
DCP time slots for the first half of 2012
From 1 April 2011 to 30 April 2011, the Danish Medicines Agency resumes the allocation of DCP time slots for the first half of 2012.
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02 March 2011 /Authorisation and supervision
Compliance check of package leaflets and product labelling (winter 2011)
The companies are responsible for ensuring that the package leaflets and labelling of medicines comply with the Danish executive order on labelling. The Danish Medicines Agency regularly carries out random compliance checks of package leaflets and product labelling. Below, you can see which medicines we have checked during winter 2011. Our compliance check has meant that the labelling or package leaflets of a number of the medicines have been or will be changed.
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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.
