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31 January 2012 /Side effects and trials
Older contraceptive pills still pose the lowest risk of blood clots
The Danish Medicines Agency has reviewed the most important literature on contraceptive pills and the risk of blood clots as well as the most recent data on consumption and reported side effects in Denmark. The Danish Medicines Agency therefore encourages doctors to reduce the known risk factors for blood clots by prescribing 2nd generation contraceptive pills as the first choice to the extent possible.
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31 January 2012 /Authorisation and supervision
New revised Danish translation of the PhVWP's recommendation for the product information of ophthalmic beta-blockers
The European Pharmacovigilance Working Party, PhVWP, has once again revised its recommendation for the wording of the product information for ophthalmic beta-blockers. The package leaflet has been revised in order to bring the contraindications into agreement with item 4.3 of the summary of product characteristics.
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31 January 2012 /Side effects and trials
New report on long-term treatment of osteoporosis patients with bisphosphonates
In a new report "Long-term treatment of osteoporosis patients with bisphosphonates", the Danish Medicines Agency reviews treatment patterns and evidence of suspected adverse reactions of long-term treatment with bisphosphonates.
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30 January 2012 /News - miscellaneous
No signs of correlation between urine-derived fertility products and Creutzfeldt-Jakob
Foreign reports have described detection of prion in urine-derived fertility hormones, and there have been speculations about a possible association with Creutzfeldt-Jakob Disease. A linkage of Danish registers has provided no basis for such a conclusion.
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27 January 2012 /Legislation
Many more doctors in Denmark apply for permission to cooperate with the industry
In recent years, we have seen a sharp rise in the number of applications whereby doctors request permission to cooperate with a pharmaceutical company. The increase follows the Danish Medicines Agency's persistent efforts through awareness-raising campaigns and new legislation.
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26 January 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 19 January 2012
In this issue of Danish Pharmacovigilance Update read about the risk that patients treated with statins develop diabetes, and proton-pump inhibitors (PPI) and the risk of hypomagnesaemia with long-term use.
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25 January 2012 /Prices and reimbursement
Review concluded regarding general reimbursement for Xarelto®
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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25 January 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of Strattera (atomoxetine)
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for Strattera (atomoxetine). The Danish Medicines Agency has now translated this recommendation into Danish.
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24 January 2012 /Product areas
Problems with ASR hip implants from DePuy
The ASR hip implants from the company DePuy were recalled from the Danish market in August 2010. The product was placed on the Danish market in July 2003. As far as the Danish Medicines Agency knows, up to 618 patients in Denmark may be affected by this matter.
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23 January 2012 /Product information
Danes can now look up medicines on their mobiles
In Denmark, people can now check medicines via a new free app for mobile phones. The app is called 'Medicintjek', which literally means medicine check, and it's available for download on iPhone and Android mobiles. It is a service offered free of charge by the Danish Medicines Agency for anyone interested.Through one single entry point, Medicintjek gives access to information in Danish from the websites medicinpriser.dk, medicinkombination.dk, indlaegsseddel.dk and laegemiddelstyrelsen.dk, which are all run by the Danish Medicines Agency.
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20 January 2012 /Prices and reimbursement
Review concluded regarding general reimbursement for Zomig Nasal®
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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20 January 2012 /Authorisation and supervision
Updating of summaries of product characteristics prompted by changed ATC codes for 2012
Marketing authorisation holders of medicinal products authorised under the Decentralised Procedure and the Mutual Recognition Procedure should be aware that some ATC codes have been changed in 2012.
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17 January 2012 /Prices and reimbursement
Decision on general reimbursement for Yellox®
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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16 January 2012 /Prices and reimbursement
Review concluded regarding general reimbursement for Multaq®
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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13 January 2012 /Product information
Warning against Green Coffee 800
A slimming coffee that could give serious side effects because it contains the active substance sibutramine has been sold from a Danish website, which has now been closed. We warn Danish consumers against using the product due to the risk of side effects.
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13 January 2012 /Prices and reimbursement
Reassessment of reimbursement status of antidiabetic medicines (ATC group A10)
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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12 January 2012 /Product information
Dangerous medicine concealed in weight-loss products
Warning against unauthorised weight-loss medicine in juice, tea, coffee, etc. In the past year, the Danish Medicines Agency has noted an increase in unauthorised products that contain the active substance sibutramine. It is included in a variety of products such as tea, coffee, milkshake and juice. Often, there is no way of telling from the products that they contain sibutramine.
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11 January 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – December 2011
The EU Pharmacovigilance Working Party (PhVWP) convened on 12-14 December 2011. Please find an extract of some of the topics discussed.
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10 January 2012 /Authorisation and supervision
Danish Medicines Agency resumes allocation of DCP time slots for the period July-October 2012
From 16 January until 6 February 2012, the Danish Medicines Agency accepts request for DCP time slots with Denmark as reference member state (RMS) for the period July-October 2012.
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09 January 2012 /News - miscellaneous
Still possible to report suspected illegal activities with medicines anonymously
At the end of 2010, the Danish Medicines Agency made it possible for people to file an anonymous report on suspected illegal activities with medicines. During 2012, the Danish Medicines Agency will expand the scheme, making it possible to report anonymously any illegal activities in areas regulated by the Danish Medicines Agency in the form of medical devices, tissues and cells, etc.
