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Danish Pharmacovigilance Update, 23 May 2013
| 17 June 2013 |
In this issue of Danish Pharmacovigilance Update: Cases of necrotising fasciitis associated with the use of bevacizumab (Avastin®).
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Danish Pharmacovigilance Update, 25 April 2013
| 29 May 2013 |
In this issue of Danish Pharmacovigilance Update: Cerebral haemorrhage in association with the use of methylphenidate (Ritalin® etc.).
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Painkillers to be prescription only in Denmark from 30 September 2013
| 28 May 2013 |
The Danish Health and Medicines Authority has decided that large packs of mild painkillers will be prescription-only in Denmark from 30 September 2013. From this date, it will only be possible to buy small packs of mild painkillers over the counter. There will be no changes to dispensing status of the medicines that can be bought over the counter after 30 September.
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Danish Pharmacovigilance Update, 21 March 2013
| 25 April 2013 |
In this issue of Danish Pharmacovigilance Update: Depressive and suicidal thoughts following discontinuation of varenicline (Champix®).
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Danish Pharmacovigilance Update, 21 February 2013
| 25 April 2013 |
In this issue of Danish Pharmacovigilance Update: Cardiovascular monitoring when initiating and re-initiating treatment with fingolimod (Gilenya®).
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Painkillers to be prescription only in Denmark
| 08 April 2013 |
In Denmark, it will soon only be possible to buy large packs of mild painkillers when prescribed by a doctor. The aim is to reduce poisoning incidents and the need for liver transplants.
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Danish Pharmacovigilance Update, 17 January 2013
| 26 March 2013 |
In this issue of Danish Pharmacovigilance Update: The Pharmacovigilance Risk Assessment Committee, PRAC, finds that the risks outweigh the benefits from the use of Tredaptive®
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Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"
| 08 March 2012 |
We have completed our review of an application for general reimbursement for Valsartan/Hydrochlorothiazide "Actavis". The product is neither eligible for general nor general conditional reimbursement.
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Comments received on the reassessment of reimbursement status of antidiabetic medicines (ATC group A10)
| 06 March 2012 |
The Danish National Board of Health has received a number of comments from stakeholders about the Reimbursement Committee's discussion of the reimbursement status of antidiabetic medicines (ATC group A10).
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Decision on general conditional reimbursement for alendronate-containing medicines
| 22 February 2012 |
In cooperation with the Reimbursement Committee, we have decided to grant alendronate-containing medicines general conditional reimbursement from 5 March 2012. Reimbursement is conditional as it is reserved for patients with low-energy hip fractures. For any other patients who are treated with alendronate, the doctor must apply for single reimbursement, and the guiding criteria for single reimbursement remain unchanged for these patients. Alendronate is used for the treatment of osteoporosis (brittle bones).
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Changed criteria for single reimbursement for osteoporosis medicines other than alendronate
| 22 February 2012 |
As of 5 March 2012, it will only be possible to obtain a single reimbursement grant for the other medicines used in osteoporosis treatment for patients that cannot use alendronate. The criteria for single reimbursement are changed because of the large price gaps between the different medicines, where the reimbursement price of alendronate is by far the lowest.
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Applications for general reimbursement in 2011
| 02 February 2012 |
In 2011, we reviewed 21 applications for general reimbursement for 20 different medicinal products. 15 of the applications ended with the granting of general reimbursement or general conditional reimbursement, and the remaining six applications were refused.
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Review concluded regarding general reimbursement for Xarelto®
| 25 January 2012 |
The Danish Medicines Agency has completed its review of an application for general reimbursement for two new strengths of Xarelto®. The product maintains general reimbursement.
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Review concluded regarding general reimbursement for Zomig Nasal®
| 20 January 2012 |
The Danish Medicines Agency has completed its review of an application for general reimbursement for Zomig Nasal®. The product has been granted general reimbursement.
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Decision on general reimbursement for Yellox®
| 17 January 2012 |
The Danish Medicines Agency has completed its review of an application for general reimbursement for Yellox®. The product has been granted general reimbursement.
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Review concluded regarding general reimbursement for Multaq®
| 16 January 2012 |
The Danish Medicines Agency has completed its review of an application for general reimbursement for Multaq®. The product is neither eligible for general nor general conditional reimbursement.
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Reassessment of reimbursement status of antidiabetic medicines (ATC group A10)
| 13 January 2012 |
On 22 December 2009, the Danish Medicines Agency announced that we would begin our reassessment of the reimbursement status of a number of groups of medicines, including antidiabetics (ATC group A10). Within a few months, the Reimbursement Committee will begin to discuss the reimbursement status of antidiabetics.
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Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of strong painkillers (opioids)
| 05 January 2012 |
At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group N02A, opioids, as well as certain medicines in ATC groups N07BC and R05DA.
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Comments received on the reassessment of reimbursement status of strong analgesics (opioids)
| 04 November 2011 |
The Danish Medicines Agency has received a number of comments for the Reimbursement Committee's discussion of reimbursement status of strong analgesics (opioids). These comments were presented to the Reimbursement Committee at its meeting on 27 September 2011. The Reimbursement Committee is currently processing a recommendation.
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Changed reimbursement for medicines for depression and anxiety as of 5 March 2012
| 07 October 2011 |
With effect from 5 March 2012, the reimbursement is changed for certain medicinal products for treatment of depression and anxiety (antidepressants and anxiolytics). Based on the Reimbursement Committee's recommendation, the Danish Medicines Agency has decided that in future the general rule is that treatment with inexpensive medicines (e.g. sertraline and citalopram) must be attempted before reimbursement can be granted for more expensive medicines (e.g. escitalopram, duloxetine, pregabalin and agomelatine).
