News
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Danish Pharmacovigilance Update 19 December 2013
| 17 February 2014 |
In this issue of Danish Pharmacovigilance Update: Patients with mechanical heart valves should not be treated with the new oral anticoagulants Pradaxa®, Xarelto® and Eliquis®.
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Danish Pharmacovigilance Update 28 November 2013
| 03 February 2014 |
In this issue of Danish Pharmacovigilance Update: Ciprofloxacin and the risk of tendon disorders, risk of blood clots from the use of the cancer medicine ponatinib and reporting of adverse reactions to the Danish Health and Medicines Authority.
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Danish Pharmacovigilance Update, 26 September 2013
| 21 November 2013 |
In this issue of Danish Pharmacovigilance Update: Filgrastim (Neupogen) and pegfilgrastim (Neulasta) are associated with risk of capillary leak syndrome.
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Danish Pharmacovigilance Update, 29 August 2013
| 23 October 2013 |
In this issue of Danish Pharmacovigilance Update: Cases of acquired haemophilia following treatment with clopidogrel (Plavix® etc.)
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Danish Pharmacovigilance Update, 27 June 2013
| 24 July 2013 |
In this issue of Danish Pharmacovigilance Update: The benefits of medicines for the treatment of acne (Diane® Mite and others) continue to outweigh the risks of use within the indication.
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Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications
| 09 July 2013 |
The Voluntary Harmonisation Procedure is a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.
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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.