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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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22 October 2010 /Product information
Important information for diabetics: GlucaGen® Hypokit 1 mg for injection recalled in Denmark
Novo Nordisk A/S in Denmark is recalling a defective batch of GlucaGen® Hypokit, which is used to treat severe hypoglycaemia (low blood sugar) in diabetes.
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20 October 2010 /Prices and reimbursement
General reimbursement for medicines containing losartan in combination with hydrochlorothiazide
Patients can now receive general reimbursement for all medicines containing losartan in combination with hydrochlorothiazide. This also includes medicines containing a combination of losartan 100 mg and hydrochlorothiazide 12.5 mg
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18 October 2010 /News - miscellaneous
Expiry of transitional arrangement for traditional herbal medicinal products and natural medicinal products
Since 2005, it has been possible in Denmark to have traditional herbal medicinal products registered as an alternative way of bringing herbal medicines onto the Danish market.
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14 October 2010 /Retail and online sale
Global operation targeting illegal and counterfeit medicines
More than 40 countries have taken part in an international week of action targeting the online sale of counterfeit and illegal medicines to raise awareness of the associated health risks, resulting in arrests across the globe and the seizure of thousands of potentially harmful medicines.
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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.
