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11 August 2011 /Side effects and trials
Danish Drug Interaction Database expanded significantly
The Danish website interaktionsdatabasen.dk, where you can find information about interactions between various medicines, has been improved significantly. The Drug Interaction Database is in Danish only. Among the improvements is a general overview of how two different categories of medicinal product groups interact (class effect), the hospital pharmacies' SAD products have been included, and finally, you can search on both active substance and product names for herbal remedies as well as vitamins.
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29 July 2011 /Authorisation and supervision
New guidelines on submittable formats for applications for marketing authorisation, variations, etc.
The Danish Medicines Agency has formulated new guidelines on submittable formats for applications for marketing authorisation, variations, update prior to MRP, renewal, follow-up and referral to CMD. In addition, the guidelines on submission of paper applications have been revised. The new guidelines are intended to make it easier for companies to submit applications electronically and to ease our electronic processing of applications.
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27 July 2011 /Product information
Limited availability of Thyrogen® (thyrotropin alfa) expected to continue in 2011 and 2012
In March 2011, the Danish Medicines Agency together with the manufacturer of Thyrogen® announced that Thyrogen® would be in limited supply until July 2011. However, it is now estimated that the limited supply of Thyrogen® will persist throughout 2011 and in 2012 due to unexpected delays in the release of three lots destined for global markets.
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26 July 2011 /Authorisation and supervision
New labelling order effective on 28 July 2011
A new executive order no. 869 of 21 July 2011 on the labelling etc. of medicinal products (labelling order) enters into force on 28 July 2011. Most provisions of the new labelling order are unaltered compared to executive order no. 1210 of 7 December 2005 on labelling etc. of medicinal products.
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22 July 2011 /Authorisation and supervision
Annual report 2010 of the Danish Medicines Agency's laboratory control activities
The Danish Medicines Agency's Laboratory has published an annual report for 2010 that describes our activities within the European network called the Official Medicines Control Laboratories (OMCL).
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21 July 2011 /Side effects and trials
Update on Pandemrix® and narcolepsy
As mentioned in the announcement from 30 June, the case about Pandemrix® and narcolepsy was to be re-evaluated by the member states' experts at the meeting in the European Medicines Agency (EMA), this week. The latest evaluation has resulted in the following recommendation: Pandemrix® should not be used in persons under the age of 20 unless there is no seasonal flu vaccine that protects against influenza H1N1. In Denmark, the seasonal flu vaccine will protect against influenza H1N1.
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21 July 2011 /Side effects and trials
EMA recommends to restrict the use of a particular diabetes medicine
The European Medicines Agency EMA reacts to information stating that diabetics who are treated with the medicine pioglitazone have a slightly increased risk of bladder cancer.
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21 July 2011 /Side effects and trials
EMA concludes benefits of the smoking cessation product Champix® (varenicline) still outweigh risks
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has assessed a new study that suggests that the smoking cessation product Champix® (varenicline) may be associated with a risk of cardiovascular events.
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18 July 2011 /Authorisation and supervision
Update for tissue establishments about the West Nile Virus and quarantine
In cooperation with the Danish National Board of Health, the Danish Medicines Agency wishes to inform tissue establishments in Denmark about the risk of exposure to the West Nile Virus.
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18 July 2011 /Retail and online sale
Scam company behind sundeled.dk still makes empty threats of debt collection
Since our warning in April against the scam company behind the website sundeled.dk, calling itself Helse Danmark A/S, the number of seized packages of glucosamine sent to Denmark illegally from the scam company in Singapore has dropped to almost none. Helse Danmark A/S is not registered in Denmark. The Danish Medicines Agency considers the company to be fake and has reported sundeled.dk to the police for illegal sale of medicines.
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14 July 2011 /Authorisation and supervision
Licensing of medicines prioritisation and forecast processing times for the second half of 2011
Every six months, we prioritise and forecast processing times for the authorisation of medicines. Our forecast for the second half of 2011 and status on the first half of 2011 are now ready.
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13 July 2011 /Authorisation and supervision
Danish translations of the PhVWP recommendations for the wording of product information are now available on our website
The Danish Medicines Agency has translated a series of recommendations for the wording of summaries of product characteristics and package leaflets, prepared by the European Pharmacovigilance Working Party, PhVWP. The Danish translations are now available on our website.
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13 July 2011 | Updated 13 July 2011 /About us
Problem receiving emails now solved
The problems we experienced earlier today with sending and receiving emails have now been solved. There is no indication that emails are lost.
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13 July 2011 /Authorisation and supervision
Generic substitution terminated for oral medicines containing cyclosporine or tacrolimus
With regard to generic medicines for oral use that contain cyclosporine or tacrolimus, it has so far been possible to label these as generically substitutable if the medicines were assessed to be therapeutically interchangeable. Provided, however, that bioequivalence between the generic version and the original product is established based on stringent criteria. Following a reassessment, the Danish Medicines Agency now considers that generic substitution should no longer be possible for these to active substances.
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11 July 2011 /Side effects and trials
Electronic clinical trial applications do not meet format requirements
A month ago, the Danish Medicines Agency announced that it is possible to submit clinical trial applications electronically, and we are happy to see that many have taken advantage of this possibility. Unfortunately, quite many of the applications do not comply with the requested format.
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11 July 2011 /Side effects and trials
New list clarifies requirements for amendments to clinical trials
The Danish Medicines Agency receives many questions regarding which amendments to clinical trials are to be notified to the Danish Medicines Agency, in particular because the European guideline CT 1 has been revised.
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11 July 2011 /Side effects and trials
Acne product isotretinoin not to be used during pregnancy
Women of child-bearing age must not use the acne product isotretinoin, unless a number of criteria are met. This contraindication has been in force since 2003 and applies to all medicines with the active substance isotretinoin. Even so, it still occurs that women fall pregnant even though they are treated with isotretinoin. A recent European report shows that since 2003, the European database of side effects has received reports of more than 80 pregnancies involving the original isotretinoin product (Roaccutan®, no longer marketed in Denmark) and several hundreds of pregnancies involving all isotretinoin products (Roaccutan® as well as generic versions).
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07 July 2011 /Side effects and trials
Risk of the rare but serious adverse reaction methemoglobinemia from the use of benzocaine-containing products used to relieve teething pain
Following a review of data, the U.S. Food and Drug Administration (FDA) has warned against the use of medicines containing the local anesthetic benzocaine in children less than two years of age. The reason is the risk of the rare but potentially serious adverse reaction, methemoglobinemia.
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06 July 2011 /Side effects and trials
Recent study suggests risk of cardiac events associated with the smoking cessation product Champix® (varenicline)
The Danish Medicines Agency is aware of a new study that suggests that the smoking cessation product Champix® (varenicline) may be associated with a risk of cardiac events.
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05 July 2011 /Prices and reimbursement
Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines in ATC group C01 (cardiac therapy)
At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group C01 – cardiac therapy. These medicines are used for the treatment of cardiac arrhythmia (e.g. atrial fibrillation) and heart cramps (angina pectoris).
