Publications
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Number of applications for individual reimbursement of medicines in 2010
| 14 June 2011 |
In 2010, we reached decisions in a total of 144,324 individual reimbursement applications against 138,714 in 2009, corresponding to an increase of 4 %. The figure breaks down to approx. 96,000 applications for single reimbursement (about 3 % fewer than in 2009), approx. 34,000 applications for reimbursement for the chronically ill (about 30 % more than in 2009), approx. 12,000 applications for reimbursement for the terminally ill (about 7 % more than in 2009) and approx. 2,800 applications for increased reimbursement (about 14 % more than in 2009).
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Report on the blood product area in 2009
| 17 August 2010 |
In 2009, 358.000 blood collections were made in Denmark. This is approximately 4.000 collections more than the previous year. Moreover, approximately 332.000 units of red blood cells (erythrocytes) were used in connection with blood transfusions in 2009.
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Assessment of safety of methylphenidate in ADHD treatment
| 29 October 2010 |
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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Product defects and withdrawal of medicinal products in 2006
| 26 July 2007 |
In 2006 there were more reports on product defects compared with 2005. The reports concerned both marketed and non-marketed medicinal products. including magistral medicinal products which are manufactured according to a doctor's directions.
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Report on the blood product area in 2008
| 02 September 2009 |
The blood product report is published every year based on figures from the Danish blood centres and the Blood-donors in Denmark.
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Report on action against the sale of illegal medicinal products on the internet
| 22 December 2006 |
In November/December 2006, the Danish Medicines Agency carried out an internet action against the illegal sale of medicinal products over the internet. The action primarily focused on potency and diet products.
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Account of the blood product area in 2005
| 21 September 2006 |
The account contains figures about the collection of blood from donors and the use of the blood collected. The account is published annually based on figures from blood centres and the Blood-donors in Denmark.
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Annual Pharmacovigilance Report 2016 of the Danish Medicines Agency
| 08 June 2017 |
The number of reports on suspected adverse reactions submitted to the DKMA in 2016 more or less levelled the year before. We received less ADR reports from physicians, but ADR reports involving patien
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Annual pharmacovigilance report 2013
| 30 June 2014 |
In 2013, the Danish Health Authority, DHMA, received the highest number of adverse reactions ever. A total of 6681 adverse reactions were reported to us, which is 35% more than the year before. The boost in reports is attributable to several aspects. A number of targeted campaigns have put increased focus on the area, but also the development and implementation of better IT services have made it easier to report adverse drug reactions (ADRs). Especially the HPV vaccine against cervical cancer got a lot of attention in 2013 and accounted for a large proportion of the ADR reports.
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Annual report 2014 - Clinical trials of medicines
| 06 July 2015 |
In 2014, DHMA received 284 applications for authorisation of clinical trials of medicines in humans, which is a decline of 3% on 2013. Commercial sponsors applied for 162 trials and researchers (non-c
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Annual Pharmacovigilance Report 2014
| 08 May 2015 |
In 2014, the number of adverse drug reaction (ADR) reports in the Danish adverse reaction database came close to 100,000. The ADR reports go as far back as the late 1960s when the first national system for registration of adverse reactions was established.
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Guide to individual case safety reporting
| 26 June 2015 |
We have prepared a guide to pharmaceutical companies about the exchange of individual case safety reports to and from the Danish Health Authority. The guide is in English and includes recommendation