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26 August 2011 /Prices and reimbursement
Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine
On 15 August 2011, the Danish Medicines Agency announced that we would begin reassessing the reimbursement status of medicines in ATC group N02A, opioids. The Reimbursement Committee opened its preliminary discussions at its meeting on 23 August 2011 and recommended to include the opioids methadone (N07BC02) and codeine (R05DA04), also used in pain management, in the reassessment of reimbursement status of medicinal products in ATC group N02A.
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26 August 2011 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for hydrochlorothiazide product information
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for hydrochlorothiazide. The Danish Medicines Agency has now translated this recommendation into Danish. The text is to be used when preparing new product information for medicines containing hydrochlorothiazide.
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23 August 2011 /Side effects and trials
Commission guidance on adverse reactions from clinical trials (CT3) has been changed
The EU Commission has updated its guidance on adverse reactions arising from clinical trials, known as CT3. In future, CT3 will also include the previous Eudravigilance guidance - clinical trial module (CT4) - as well as the Q&A document regarding adverse reaction reports in clinical trials.
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22 August 2011 /News - miscellaneous
Indication, 30 June 2011
In the June issue, catch up on the amendments to the Danish Medicines Act and more.
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19 August 2011 /News - miscellaneous
Continued fall in lice medicines sales in Denmark
In Denmark, August marks the prime time for head lice infestation when kids meet up at school after their holidays. But despite the increase in head lice attacks, sales of head lice medicines are headed opposite, as revealed by declining sales of the authorised medicines (Nix® and Prioderm®). And so, last year's falling trend continues.
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15 August 2011 /Prices and reimbursement
Reassessment of reimbursement status of strong analgesics (opioids)
On 22 December 2009, the Danish Medicines Agency announced that it would begin reassessing the reimbursement status of medicines in ATC group N (nervous system) starting with the ATC subgroup N06A (antidepressants) and then N02A (opioids). The Reimbursement Committee is having the initial discussions of the opioids at its meeting on 23 August 2011.
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12 August 2011 /News - miscellaneous
Report on the blood product area in 2010
In 2010, 337,000 blood collections were made in Denmark. This is approximately 21,000 collections less than the previous year.
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12 August 2011 /Prices and reimbursement
Review concluded regarding general reimbursement for Pradaxa®
The Danish Medicines Agency has completed its review of an application for continued general reimbursement for Pradaxa®. The product maintains general reimbursement. Pradaxa® is now also authorised for prevention of apoplexy (stroke) and systemic embolism in patients with atrial fibrillation.
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11 August 2011 /Side effects and trials
Danish Drug Interaction Database expanded significantly
The Danish website interaktionsdatabasen.dk, where you can find information about interactions between various medicines, has been improved significantly. The Drug Interaction Database is in Danish only. Among the improvements is a general overview of how two different categories of medicinal product groups interact (class effect), the hospital pharmacies' SAD products have been included, and finally, you can search on both active substance and product names for herbal remedies as well as vitamins.
