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29 October 2010 /Side effects and trials
Assessment of safety of methylphenidate in ADHD treatment
The Danish Medicines Agency has reviewed the data on consumption and side effects of methylphenidate-containing medicine, which is authorised for the treatment of ADHD and narcolepsy.
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29 October 2010 /Side effects and trials
Implementation of MedDRA version 13.1
MedDRA (Medical Dictionary for Regulatory Activities) is a code book of medical terminology developed by ICH (International Conference on Harmonisation).
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25 October 2010 /Side effects and trials
Adjustment of new validation rules for electronic exchange of adverse reaction data
On 11 October, the Danish Medicines Agency, implemented the updated validation rules for electronic exchange of E2B files ((ICH E2B (R2)) EV7 Release 1.
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06 October 2010 /Side effects and trials
Implementation of new validation rules for electronic exchange of adverse reaction data
Companies which report adverse reaction data to the Danish Medicines Agency are advised that on Monday 11 October 2010, we will be implementing the updated (ICH E2B (R2)) validation rules for the exchange of E2B files, which entered into force on 1 June 2010.
