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30 September 2011 /Authorisation and supervision
New guidelines on applications for company authorisations
The Danish Medicines Agency has prepared a number of new guidelines on applications for company authorisations.
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30 September 2011 /Retail and online sale
Global operation strikes at online sale of illegal and counterfeit medicines - "Operation PANGEA IV"
In the past week, more than 165 regulatory authorities from 81 countries took part in "Operation PANGEA IV", a global action against online trading of counterfeit and illegal drugs. The operation sets out to raise awareness about the risks associated with buying medicines on the internet and through joint efforts to bring these offences to justice.
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30 September 2011 /Product information
Dangerous sex pills on the market
A control and awareness-raising campaign organised jointly by the Danish Veterinary and Food Administration and the Danish Medicines Agency has found that several erotic shops in Copenhagen sell sex pills containing herbal ingredients that could damage the liver and nervous system or could have other harmful effects.
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06 May 2011 | Updated 30 September 2011 /Authorisation and supervision
Errors found at more than one in five alternative practitioners
More than one in five alternative practitioners visited by the Danish Veterinary and Food Administration and the Danish Medicines Agency in a series of joint on-site inspections last year were unfamiliar with the regulations for the food supplements and medicines on their shelves. This is the result of a report based on more than 50 on-site inspections at alternative practitioners across Denmark.
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27 September 2011 /Side effects and trials
Danish report on treatment with SSRI antidepressants
Based on a debate about the safety of treatment with SSRI antidepressants, the Danish Medicines Agency has drawn up an overview report. The report aims to provide healthcare professionals and others involved in SSRI treatment with an overview of our current knowledge about the consumption of SSRIs and the safety of this type of medicine. The main focus of the report is on the safety of SSRIs and the risk of adverse reactions in foetuses and newborns of mothers who have used SSRI antidepressants.
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26 September 2011 /News - miscellaneous
Danish Pharmacovigilance Update, 15 September 2011
In this issue of Danish Pharmacovigilance Update, read about a significant increase in off-label use of AeroBec® in children under the age of five, and much more.
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23 September 2011 /Side effects and trials
The European Medicines Agency recommends restricted use of Multaq®
The European Medicines Agency, EMA, recommends limited use of the medicine Multaq®, which is used for cardiac arrhythmia. This is the result of an overall review of the risks and benefits of this medicine carried out by the Committee for Medicinal Products for Human Use, CHMP. The review was initiated in January 2011 due to reports of serious liver damage in patients who had been treated with Multaq®.
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21 September 2011 /Prices and reimbursement
Review concluded regarding general reimbursement for Trajenta®
The Danish Medicines Agency has completed its review of an application for general reimbursement for Trajenta®. The product has been granted general reimbursement.
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14 September 2011 | Updated 21 September 2011 /About us
Biological Assessor for the Licensing Division in the Danish Medicines Agency
Do you hold a scientific degree in pharmacy or other biological science degree, and are you interested in working with the licensing of medicines? Then, maybe you are our new colleague in the PharmaBiotech Department in the Licensing Division of the Danish Medicines Agency.
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20 September 2011 /Prices and reimbursement
Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of glucosamine-containing medicines
The Reimbursement Committee’s recommendation on the future reimbursement status of glucosamine-containing medicines was open for consultation until 8 August 2011. The Danish Medicines Agency received 4 consultation responses.
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20 September 2011 /Prices and reimbursement
Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (ACT group N06A, etc.)
The Reimbursement Committee’s recommendation on the future reimbursement status of medicines in ATC group N06A, antidepressants, as well as certain medicines in ATC groups N03A, N05A and N05B was open for consultation until 15 August 2011. The Danish Medicines Agency received 9 consultation responses.
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20 September 2011 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance theophylline
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended Theophylline.
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20 September 2011 /Authorisation and supervision
The EDQM has suspended the Certificates of Suitability for the active substances ribavirin and tiamulin
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended Tiamulin Hydrogen for veterinary use and Ribavirin.
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16 September 2011 /Product information
Warning against the product "Weight Loss Coffee"
If you have bought Weight Loss Coffee, please do not drink it. It may be dangerous to your health, as it contains an active substance which can cause side effects.
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13 September 2011 /Side effects and trials
Citalopram and the risk of cardiac arrhythmia
The U.S. Food and Drug Administration (FDA) recently issued a warning against using large doses of the antidepressant citalopram. The FDA has reviewed data which shows that doses of citalopram of 60 mg a day may be linked with changes in the heart rate (QT interval prolongation).
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12 September 2011 /About us
Dr. Christian Schneider joins the Danish Medicines Agency as Senior Medical Officer
As of 1 October 2011, Dr. Christian Schneider will be filling the position as Senior Medical Officer in the Licensing Division of the Danish Medicines Agency.
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09 September 2011 /News - miscellaneous
Danish Pharmacovigilance Update, 18 August 2011
Among the topics covered in this issue are Vimpat® 15mg/ml syrup (lacosamide) for treatment of epilepsy, which is recalled due to a quality defect and Nplate® (romiplostim), which could increase the risk of disease progression in patients with myelodysplastic syndrome (MDS).
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08 September 2011 /Side effects and trials
New English e-form for reporting of adverse reactions in clinical trials (SUSARs)
The Danish Medicines Agency now launches an e-form in English for reporting suspected unexpected serious adverse reactions in clinical trials (SUSARs). The e-form specifically targets researchers and small and medium-sized enterprises that for some reason cannot report via EudraVigilance.
