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31 October 2011 /News - miscellaneous
FDA seminar on IVD/Medical Device Regulation and Management
On 15 to 16 November, the Danish embassy in Washington D.C. hosts a seminar in collaboration with the U.S. Food and Drug Administration (FDA) and Beaufort Advisors.
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28 October 2011 /Side effects and trials
European Medicines Agency recommends lower dose of citalopram
In October 2011, the European Pharmacovigilance Working Party has concluded to reduce the maximum dose of the antidepressant medicine citalopram. The recommendation follows from a drug trial and adverse reactions showing that citalopram may affect the heart rhythm, especially when given in high doses.
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28 October 2011 /Authorisation and supervision
Annual report on human tissues and cells shows continued rise in tissue establishment activity
The annual report on human tissues and cells is now available in English. It shows, among other things, that there were altogether 56 tissue establishments and 40 gynaecology clinics authorised to handle human tissues and cells in Denmark.
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27 October 2011 /Authorisation and supervision
Spot checks reveal insufficient information about antidepressants for pregnant and breast-feeding women
The Danish Medicines Agency has reported a number of companies to the police for having failed to update the package leaflet regarding pregnant and breast-feeding women's use of antidepressants of the SSRI type (selective serotonin reuptake inhibitors). At the same time, the Danish Medicines Agency has instructed the companies to withdraw any SSRIs with inadequate warnings.
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26 October 2011 /Authorisation and supervision
No cause for concern about influenza vaccination
A single batch of the influenza vaccine Preflucel has been withdrawn from the Danish market. 14 vaccines have been used in Denmark, and all other unused vaccines have been withdrawn from the market. There have been no reports of side effects in Denmark.
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26 October 2011 /Authorisation and supervision
Assessment times for authorisation of medicines for the first six months of 2011
We have just published our assessment times for authorisation of medicines for the first six months of 2011.
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25 October 2011 /Side effects and trials
Number of suspected adverse reactions reported to the Danish Medicines Agency for articaine
In 2006, the Danish Medicines Agency examined the risk of nerve damage from the anaesthetics that dentists use for local anaesthesia. The examination was initiated due to a suspicion raised in Denmark that one of the active substances, articaine, caused a greater risk of nerve damage than other substances. We have followed the development since then, and we have decided to review the safety again.
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24 October 2011 /Side effects and trials
Adverse reaction reports on antidepressants and pregnancy – June to October 2011
On 20 September 2011, the Danish Medicines Agency published an overview report (in Danish) on antidepressants of the SSRI type, the main focus being on safety and the risk of adverse reactions in foetuses and newborns whose mothers had taken an SSRI. In the subsequent period from 14 June 2011 to 9 October 2011, the Danish Medicines Agency has received 12 reports concerning 21 suspected adverse reactions in children/foetuses whose mothers had taken an SSRI.
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24 October 2011 /Authorisation and supervision
Statement from EMA about Advagraf® and cardiovascular medicine
The European Medicines Agency, EMA, has decided to immediately recall some batches of Advagraf® (tacrolimus) 0.5 mg prolonged-release hard capsules from pharmacies and wholesalers from a number of countries across the EU. EMA has also looked into the possible link between the use of blood pressure lowering medicines of the type angiotensin II receptor antagonists and the occurrence of new incidences of cancer. EMA found that the evidence does not suggest any link with cancer.
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21 October 2011 /Prices and reimbursement
Decision on general reimbursement for Cholestagel®
The Danish Medicines Agency has completed its review of an application for general reimbursement for Cholestagel®. The product is neither eligible for general nor general conditional reimbursement. Cholestagel® is used for treatment of elevated blood cholesterol levels.
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12 October 2011 /Prices and reimbursement
Review concluded regarding general reimbursement for Bydureon
The Danish Medicines Agency has completed its review of an application for general reimbursement for Bydureon®. The product has been granted general reimbursement. Bydureon® is used for the treatment of type 2 diabetes in adults.
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12 October 2011 /Side effects and trials
Focus on medicines most frequently involved in serious adverse drug events can improve patient safety
A new study carried out by a working group associated with the Danish Medicines Agency's network "Prevention of Medication Errors" has shown that it is more or less the same groups of medicines that have been involved in the so-called adverse events from the 1970s and up until today. Based on the study, we have drawn up two lists of medicines that appear in high-risk situations – sorted by active substance and medicine group. The Danish Medicines Agency and the working group behind the study hope that these lists can become an important tool in the daily work with risks in the medication process in the health sector.
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07 October 2011 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance oxytetracycline
The European Directorate for the Quality of Medicines and Healthcare, has suspended the Certificate of Suitability for oxytetracycline.
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07 October 2011 /Prices and reimbursement
Changed reimbursement for medicines for depression and anxiety as of 5 March 2012
With effect from 5 March 2012, the reimbursement is changed for certain medicinal products for treatment of depression and anxiety (antidepressants and anxiolytics). Based on the Reimbursement Committee's recommendation, the Danish Medicines Agency has decided that in future the general rule is that treatment with inexpensive medicines (e.g. sertraline and citalopram) must be attempted before reimbursement can be granted for more expensive medicines (e.g. escitalopram, duloxetine, pregabalin and agomelatine).
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04 October 2011 /Prices and reimbursement
The reimbursement for glucosamine is removed on 28 November 2011
The Reimbursement Committee and the Danish Medicines Agency have reassessed the reimbursement status of glucosamine-containing medicines. We have decided to remove the reimbursement for these over-the-counter medicines on 28 November 2011. Glucosamine is used for the alleviation of painful osteoarthritis.
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04 October 2011 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – September 2011
The EU Pharmacovigilance Working Party (PhVWP) convened on 19-21 September. On the meeting's agenda was: active substances with a known risk of Stevens-Johnson syndrome and toxic epidermal necrolysis.
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04 October 2011 /Side effects and trials
Monthly reports from the EU Pharmacovigilance Working Party, PhVWP – June and July 2011
The EU Pharmacovigilance Working Party (PhVWP) convened on 20-22 June and 18- 20 July 2011.
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03 October 2011 /Authorisation and supervision
Changed practice for authorisations for wholesale distribution of medicines within the EU/EEA
The Danish Medicines Agency has changed its practice with respect to the format of authorisations for wholesale distribution of medicines within the EU/EEA. The change concerns the application form's Annex A.1 in which applicants are now only to indicate activities that the company carries out at its own address. Likewise, Annex A.1 of the wholesale dealer's authorisation will only list the activities performed at the company's own address.
