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30 September 2008 /Side effects and trials
Report all side effects from Gardasil®
From 1 October 2008 and two years onwards, the Danish Medicines Agency implements special monitoring of side effects (adverse reactions) fron the Gardasil® cervical cancer vaccine.
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26 September 2008 /Side effects and trials
EMEA recommends update of the product information for the sclerosis medicine Tysabri®
The EMEA's Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for the sclerosis medicine Tysabri® (natalizumab) be updated.
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26 September 2008 /Prices and reimbursement
From 1 January 2009, all changes to prices and product range must be reported electronically at DKMAnet – Prices & Packages
From 1 January 2009 changes in prices and product range for medicinal products can no longer be sent by fax. In future, notifications must be sent electronically at DKMAnet - Prices & Packages.
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19 September 2008 /Product information
National meeting about the Pharmaceutical Forum held 12 September 2008
On 12 September 2008, the Danish Medicines Agency hosted a national meeting about the Pharmaceutical Forum held by the Danish Ministry of Health and Prevention and the Danish Medicines Agency.
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12 September 2008 /Authorisation and supervision
The Danish Medicines Agency's work with tissues and cells in 2007 and 2008
The use of human tissues and cells is expanding, and since the implementation of the Danish Issue Act in 2007, the Danish Medicines Agency performs an increasing number of tasks within this field.
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12 September 2008 /Product information
Withdrawal of the asthma and lung medicine Oxis Turbohaler® with batch no. IA763-3
2care4 has, in cooperation with the Danish Medicines Agency, chosen to withdraw Oxis Turbohaler® with batch no. IA763-3 from Danish pharmacies. The company has chosen to do so because of the risk that packages in this batch may contain turbohalers with the wrong dose relative to the strength stated on the package.
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10 September 2008 /Side effects and trials
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08 September 2008 /Prices and reimbursement
Reassessment of reimbursement status of medicinal products for cardiovascular diseases – additional recommendation from the Reimbursement Committee
The Danish Medicines Agency has asked the Reimbursement Committee to reassess the reimbursement status of medicinal products authorised for marketing in Denmark in the ATC groups C02 (antihypertensives), C03 (diuretics), C07 (beta blocking agents), C08 (calcium channel blockers) and C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors).
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29 August 2008 /Side effects and trials
EU directive does not result in fewer clinical trials from independent researchers
In 2004, when the CT directive came into force, the GCP-rules became mandatory for the independent researchers and they were to meet the same requirements as their colleagues in the pharmaceutical industry - something which led many people to fear that it would result in less public research.
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27 August 2008 /Product information
Thalidomide Pharmion (thalidomide) on the Danish market as of 25 August 2008
Thalidomide Pharmion is authorised in the EU as first line treatment of multiple myeloma, which is a relatively rare cancer of the bone marrow. Thalidomide Pharmion must be given in combination with the medicines melphalan and prednisone.
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13 August 2008 /Side effects and trials
EMEA assesses incidents of progressive multifocal leukoencephalopathy (PML) in sclerosis patients receiving Tysabri®
The European Medicines Agency (EMEA) has received two reports of progressive multifocal leukoencephalopathy (PML) in patients with relapsing-remitting multiple sclerosis (MS).
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11 August 2008 /Side effects and trials
Antiepileptics and increased risk of suicidal thoughts and behaviour
The European Medicines Agency (EMEA) has concluded that antiepileptics may entail a slight risk of suicidal thoughts and behaviour.
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11 August 2008 /Product information
Warning against the product Melanotan
The Danish Medicines Agency has been made aware of the product, Melanotan, which is sold via the internet. The product is marketed as a product that increases pigmentation, providing tanned skin and protection against the harmful rays of the sun, implying that it may prevent skin cancer. However, this effect has not been documented.
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25 July 2008 /Product information
EMEA recommends restricting the use of oral moxifloxacin-containing medicines
The European Medicines Agency (EMEA) has reviewed the safety of moxifloxacin-containing medicines for oral use. The EMEA has concluded that these medicines should only be prescribed for the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed.
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25 July 2008 /Product information
EMEA recommends restricted use of oral norfloxacin-containing medicines in urinary infections
The European Medicines Agency has recommended restricting the use of oral norfloxacin-containing medicines in urinary infections.
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25 July 2008 /Product information
No increased risk of developing cancer for patients having taken Viracept® contaminated with ethyl mesilate
Following a review of a number of toxicology studies, the European Medicines Agency (EMEA) has confirmed that there is no increased risk of development of cancer for patients who have taken contaminated Viracept® (Nelfinavir).
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23 July 2008 /Side effects and trials
Side effects from statins (simvastatin, pravastatin, lovastatin, fluvastatin, atorvastatin, rosuvastatin)
Statins are used to treat high cholesterol. As part of its regular monitoring of adverse reactions, the EU agencies are presently investigating the following types of adverse reactions.
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21 July 2008 /Prices and reimbursement
New guidelines for application for general reimbursement of medicinal products
The Danish Medicines Agency's Guidelines for application for general reimbursement of medicinal products were issued on 4 June 2008, replacing the Guidelines for application for general reimbursement of medicinal products of 25 April 2006
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15 July 2008 /Product information
Warning against the product Viamax Energizer
The Danish Medicines Agency has become aware of the product Viamax Energizer, which is sold on the internet as a product providing energy. An analysis carried out by the Swedish Medical Products Agency has shown that the product contains the active substances levodopa and theophylline, which does not appear from the packages.
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14 July 2008 /Authorisation and supervision
