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30 June 2011 /Side effects and trials
Swedish study increases suspicion about link between the pandemic vaccine Pandemrix® and the sleep disorder narcolepsy in children and adolescents
The Swedish Medical Products Agency has published the result of an epidemiological study which increases suspicion about a link between the sleep disorder narcolepsy in children and adolescents and vaccination with Pandemrix® against influenza A(H1N1). There are still no known Danish incidents of narcolepsy in children and adolescents vaccinated with Pandemrix.
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30 June 2011 /Legislation
More doctors must apply for authorisation to cooperate with the pharmaceutical industry from 1 July 2011
If a Danish doctor or dentist wishes to establish a relationship with, be employed at, or run a pharmaceutical company and at the same time prescribe medicines to patients, he or she must apply to the Danish Medicines Agency for permission to do so. An amendment to the Danish Pharmacy Act as of 1 July 2011 means however that in future, Chief Medical or Dental Officers who do not prescribe medicine will in certain cases also be comprised by the Act.
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29 June 2011 /Side effects and trials
Problems with dispatching acknowledgement messages (ACKs) for adverse reaction reports from comapanies
The Danish Medicines Agency had network problems on Wednesday 15 June 2011. Consequently, a very large number of adverse reaction reports failed in our EudraVigilance Gateway. Unfortunately, as a result of our problems with the gateway, a considerable number of reports have piled up (backlog). Therefore, there will most likely be delays in dispatching ACKs. We hope to straighten out the situation by the end of the weekend.
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28 June 2011 /Prices and reimbursement
Decision on future reimbursement status of medicines in ATC group C05 (vasoprotectives)
On 27 June 2011, the Danish Medicines Agency decided on the future reimbursement status of medicines in ATC group C05 (vasoprotectives). These medicines will still not be eligible for general reimbursement.
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27 June 2011 /News - miscellaneous
Danish Pharmacovigilance Update, 16 June 2011
Among the articles in this issue of Danish Pharmacovigilance Update, you can read about the removal of contraindication for Velcade® (bortezomib) used for the treatment of multiple myeloma.
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24 June 2011 /Side effects and trials
Amendments to the guideline on clinical trials in humans
In the Danish Medicines Agency's Clinical Trials department we have reviewed approx. 30 research-initiated applications for authorisation to conduct medicinal product trials submitted in 2010. The review was conducted to assess the need for improved guidance.
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23 June 2011 /Side effects and trials
Need for further review of the risks related to diabetes medicines
Over the past few days, the European Committee for Medicinal Products for Human Use (CHMP) has fast-tracked the results of a new French study. The study shows a small increased risk of bladder cancer in diabetics treated with pioglitazone-containing diabetes medicines. However, the CHMP could not completely confirm an increased risk. Therefore, the Danish Medicines Agency advises Danes to continue their treatment with pioglitazone (contained in the diabetes medicine Actos®).
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23 June 2011 /News - miscellaneous
Urine-derived fertility medicines are still safe
The Danish Medicines Agency has been made aware of a recent discussion on Facebook about detection of prions (naturally occurring proteins) in urine-derived fertility medicines and a discussion of the medicine's safety. The Danish Medicines Agency advises that the prions in urine-derived fertility medicines that we referred to in our announcement on 2 May 2011 have not been associated to diseases - including the brain disease Creutzfeldt-Jakob disease.
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23 June 2011 /Side effects and trials
Errors in the dating and the number of adverse reaction reports
The Danish Medicines Agency had network problems on Wednesday 15 June 2011. Consequently, a very large number of adverse reaction reports failed in our EudraVigilance Gateway.
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22 June 2011 /News - miscellaneous
Indication, 27 May 2011
The May issue of the Danish Medicines Agency's newsletter Indication has now been issued. In the newsletter, you can read that medstat.dk has been improved. It is now easier to gain access to statistics on the sale of medicines in Denmark.
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21 June 2011 /Retail and online sale
Pharmacists and pharmaconomists qualified outside Denmark can participate in an EU competition
At the Danish Medicines Agency, we assess the qualifications of foreign pharmacists and pharmaconomists who apply for authorisation to work at a Danish pharmacy. The EU Commission and the upcoming Polish EU Presidency are presently looking for real-life stories from citizens who have experience from living and working abroad.
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20 June 2011 /Product information
Warning against the tanning product Melanotan
The Danish Medicines Agency repeats its warning against using the illegal product Melanotan because its effect is not documented and because of the absence of studies of its potential side effects. The Danish Medicines Agency urges everyone who uses Melanotan to stop using it and to contact their doctor if concerned.
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20 June 2011 /Side effects and trials
Annual report on the Danish Medicines Agency's activities within the pharmacovigilance area in 2010
In 2010, primarily the Danish Minister for the Interior and Health's action plan to improve monitoring of side effects marked the work in the pharmacovigilance area. The action plan was launched in 2009 in cooperation with the Council for Adverse Drug Reactions and was fully implemented in 2010. The annual report offers an insight into much of the pharmacovigilance work performed by the Danish Medicines Agency in 2010.
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14 June 2011 | Updated 17 June 2011 /Side effects and trials
Risk of venous thromboembolism (blood clots) from use of 4th generation contraceptive pills
Women who use 4th generation contraceptive pills should read and follow the instructions of the package leaflet supplied with the contraceptive pills and contact their own doctor if unsure about the treatment.
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16 June 2011 /Product information
Warning against dangerous arthritis product Beline Capsules
The Danish Medicines Agency warns strongly against taking the arthritis product Beline Capsules based on analyses made by the Danish Medicines Agency and the Medical Products Agency in Sweden.
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16 June 2011 /Side effects and trials
Problems with dispatching adverse reaction reports and acknowledgement messages (ACK) on 15-16 June
In connection with a clean up of failed adverse reaction reports Thursday morning 16 June 2011, some reports may have been dispatched more than once.
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16 June 2011 /Side effects and trials
Risk of heart malformations in children of mothers treated with an antidepressant of the SSRI type
Epidemiological studies have shown a small increased risk of malformations in the cardiovascular system in newborns of mothers who have taken antidepressants containing fluoxetine or paroxetine in the beginning of pregnancy. In addition, the Danish Medicines Agency has received a few reports of the same type of malformations from treatment with citalopram and sertraline. Physicians are advised to follow the applicable restrictive recommendations and carefully weigh the risks and benefits of using antidepressants during pregnancy and to consider prescribing the medicines in consultation with specialists within the field (psychiatrists and/or obstetricians).
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16 June 2011 /Side effects and trials
Guide to getting started in clinical research
The Danish Ministry of Interior and Health has published a guide to getting started in clinical research, which is intended to make it easier and more attractive to engage in clinical research in Denmark. The guide is in Danish, but an English version is under way, and will be posted here on this page as soon as it is available.
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14 June 2011 /Prices and reimbursement
Review concluded regarding general reimbursement for Efient®
The Danish Medicines Agency has completed its review of an application for general reimbursement for Efient®. The product has been granted general reimbursement.
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14 June 2011 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance mesalazine
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP): CEP 2005-277 / Mesalazine
