News
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Reimbursement of medicines bought in another EU/EEA country
| 16 January 2014 |
From 1 January 2014, you can obtain reimbursement of prescription-only medicines bought in another EU/EEA country under the general reimbursement rules of the Danish Health Act. You have to be covered by the national health insurance in Denmark and have a health insurance card (the yellow card) and the medicine must be reimbursable in Denmark.
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Revocation of wholesale distribution and manufacturing authorisations granted to Singad Pharma ApS
| 15 January 2014 |
On 20 December 2013 and on 10 January 2014, the Danish Health and Medicines Authority decided to revoke the section 39 authorisations for wholesale distribution and manufacturing of medicinal products with the authorisation IDs 25081 and 25082 granted to Singad Pharma ApS (company number 255894).
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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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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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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.