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22 December 2009 /Product information
Warning against the potency-enhancing product Rock Hard Weekend
The Danish Medicines Agency strongly warns against using the potency-enhancing product Rock Hard Weekend after the FDA (U.S. Food and Drug Administration) has notified the Danish Medicines Agency that Rock Hard Weekend contains an undeclared active substance and that the product has been exported from the USA to Denmark.
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18 December 2009 /Side effects and trials
Side effects from Pandemrix® from 5 to 11 December 2009
In the period from 5 to 11 December, the Danish Medicines Agency received 68 new side effect reports covering a total of 173 suspected side effects (adverse reactions).
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17 December 2009 /Prices and reimbursement
Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)
At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders).
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14 December 2009 /Side effects and trials
Side effects from Pandemrix® from 28 November to 4 December 2009
In the period from 28 November to 4 December, the Danish Medicines Agency received 77 new side effect reports covering a total of 224 suspected side effects (adverse reactions).
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09 December 2009 /Product information
Warning against the weight-loss product Super Slim
The Danish Medicines Agency strongly warns against using the weight-loss product Super Slim. We do so based on a warning from the Swedish Medical Products Agency against Super Slim, which is sold on the internet.
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08 December 2009 /News - miscellaneous
Alternative practitioners must know regulations on health foods
If your company sells food supplements and/or medicines or if you import them from abroad, the products and your company must be registered with or authorised by the Danish authorities -
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05 December 2009 /Side effects and trials
Young children develop good protection from influenza A vaccine - but may have fever
New data show that one single vaccine dose againts influenza A (H1N1) given to children aged from six months to three years provides a good immune response, but that the second vaccine does presumably provides even better protection against the influenza.
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04 December 2009 /Side effects and trials
Side effects from Pandemrix® from 21 to 27 November 2009
In the period from 21 to 27 November, the Danish Medicines Agency received 150 new side effect reports covering a total of 475 suspected side effects
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03 December 2009 /Side effects and trials
The National Board of Health adjusts recommendations on vaccination for influenza A (H1N1)
New data from the European Medicines Agency (EMEA) have shown that it is sufficient to give one dose of vaccine for influenza A (H1N1) for persons with a functional immune system.
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02 December 2009 /Authorisation and supervision
Public access to EMA's community database EudraGMP
On 30 July 2009, EMA made it community database EudraGMP available to the public. With time, the database will contain all manufacturing and import authorisations (MIAs) for medicinal products issued to pharmaceutical companies within the EEA
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01 December 2009 /Prices and reimbursement
Decision on future reimbursement status of medicinal products in ATC groups A04 and A03FA
On 25 November 2009, the Danish Medicines Agency made a decision on the future reimbursement status of medicinal products in ATC group A04 (antiemetics and antinauseants) and medical products in ATC group A03FA (propulsives)
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27 November 2009 /Side effects and trials
Side effects from Pandemrix® from 17 to 20 November 2009
In the period from 17 to 20 November, the Danish Medicines Agency received 87 new side effect reports covering a total of 310 suspected side effects (adverse reactions).
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23 November 2009 /Side effects and trials
EMEA: H1N1 vaccine is safe and efficient
The European Medicines Agency (EMEA) has issued a press release stating that a new review of data on Pandemrix® and other vaccines against H1N1 shows that it is sufficient to use a single dose of vaccine for adults, elderly people and children aged 10 and older.
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23 November 2009 /Side effects and trials
European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents
The European Medicines Agency (EMEA) has adopted a set of recommendations aimed at minimising the risk of neophrogenic systemic fibrosis (NSF) with gadolinium-containing contrast agents in patients at risk of developing the condition.
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23 November 2009 /Side effects and trials
Gadolinium and nephrogenic systemic fibrosis: New recommendations from the European Medicines Agency
The European Medicines Agency (EMEA) has adopted new recommendations for the use of gadolinium-containing contrast agents to minimise the risk of a rare adverese reaction, neophrogenic systemic fibrosis (NSF)
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23 November 2009 /Retail and online sale
Global operation against illegal medicines takes down more than 70 websites
A global operation against illegal medicine has taken down more than 70 illegal websites,and a total of 22 individuals are currently under investigation for a range of offenses.
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20 November 2009 /Side effects and trials
Side effects from Pandemrix® from 11 to 16 November 2009
In the period of 11 - 16 November, the Danish Medicines Agency received 73 new side effect reports related to the Pandemrix® vaccine against influenza.
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23 November 2009 | Updated 19 November 2009 /Side effects and trials
Tamiflu® for prevention and treatment during an influenza epidemic
Earlier this year, the European Medicines Agency updated the product information for Tamiflu® to ensure that as many people as possible can benefit from the medicine in connection with an influenza epidemic.
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12 November 2009 /Side effects and trials
Side effects from Pandemrix® from 4 to 10 November 2009
The Danish Medicines Agency has received the first side effect reports related to the Pandemrix® vaccine against influenza.
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10 November 2009 /Authorisation and supervision
Information about variation applications from 1 January 2010
In a new regulation, the European Commission has established new rules that regulate variations of authorisations granted according to the Centralised Procedure, Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP).
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06 November 2009 /News - miscellaneous
The Danish Medicines Agency and the Danish Veterinary and Food Administration complete joint control of five sports stores
The Danish Medicines Agency and the Danish Veterinary and Food Administration complete joint control og five sports stores.
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05 November 2009 /Side effects and trials
Problem regarding receipt of adverse reaction reports now solved
Yesterday and the day before, the Danish Medicines Agency had problems receiving ICSRs and SUSARs via the EudraVigilance gateway, due to an error that occurred in the update of the message format release version.
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28 October 2009 /Side effects and trials
Adverse reactions from Gardasil® in the period 1 May – 31 August 2009
In the period May-August, the Danish Medicines Agency received 69 reports describing 145 suspected adverse reactions. The majority of the reports are not seroius, and the majority (two thirds) of the side effect are already known and described in the summary product characteristics.
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23 October 2009 /Side effects and trials
One dose of Pandemrix® against influenza A (H1N1)v for healthy adults
The Danish National Board of Health has changed its recommendation to one dose of Pandemrix® vaccine against influenza A (H1N1) for healthy adults who are offered the vaccine.
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22 October 2009 /Side effects and trials
Changed definition of safe contraception in clinical trials
We have updated section 5.1 Contraception in the Guideline for applications for authoristaion of clinical trials of medicine product in humans.
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14 October 2009 /Side effects and trials
EU Commission authorises a third vaccine against influenza A (H1N1)
The European Commission has authorised the use of Celvapan® (Baxter) as a vaccine against influenza A (H1N1). The authorisation follows last week's recommendation by the European Medicines Agency (EMEA) to the European Commission to grant a marketing authorisation for the vaccine.
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14 October 2009 /Side effects and trials
Side effects from Eltroxin® - status October 2009
The Danish Medicines Agency has recorde an increase in the number of reported side effects from Eltroxin®. The increase is observed after GlaxoSmithKline (GSK) has changed excipients contained in Eltroxin®.
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06 October 2009 /Side effects and trials
The European Medicines Agency recommends authorisation of another vaccine for pandemic influenza A (H1N1)
The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA) recommends that a marketing authorisation be granted for a third vaccine pandemic influenza A (H1N1).
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05 October 2009 /Prices and reimbursement
Decision on future reimbursement status for medicinal products in ATC group C04 (peripheral vasodilators)
On 21 September 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group (peripheral vasodilators).
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02 October 2009 /Authorisation and supervision
Control of Granocyte®
The Danish Medicines Agency has analysed two different batches of Granocyte for the presence of the active substance lenograstim.
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02 October 2009 /Authorisation and supervision
Control of Neupogen® and Neupogen Novum®
The Danish Medicines Agency has analysed three different batches of Neupogen and Neupogen Novum for the presence of the active substance filgrastim.
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02 October 2009 /Prices and reimbursement
Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C05 (Vasoprotectives)
At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group C05 (Vasoprotectives).
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01 October 2009 /Side effects and trials
EU Commission authorises two vaccines against influenza A (H1N1)
The EU Commission has authorised the use of two vaccines against influenza A (H1N1). The vaccines concerned are Focetria® (Novartis) and Pandemrix® (GlaxoSmithKline), and Pandemrix® is the one that will be used in Denmark.
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01 October 2009 /Retail and online sale
Warning: Counterfeit Viagra® sold on Danish website
The Danish Medicines Agency strongly warns against buying Viagra® on the Danish-language website www.6medicin.com/www.6medicin.dk. Analyses carried out by Pfizer (which manufactures genuine Viagra®) have proven that the Viagra® packages sold on www.6medicin.com/www.6medicin.dk are counterfeit. They are not manufactured by Pfizer.
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01 October 2009 /News - miscellaneous
Information regarding medicines containing dibutyl phthalate
The Danish Medicines Agency is presently reviewing which medicines containing dibutyl phthalate (DBP) are still on the Danish market.
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29 September 2009 /About us
New Head of Institute at the Institute for Rational Pharmacotherapy
On 1 November 2009, Steffen Thirstrup joins the Institute for Rational Pharmacotherapy as Head of Institute.
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25 September 2009 /Side effects and trials
Survey: Doctors attach great importance to patient safety - a solid foundation to increase side effect reporting
Hospitals are lagging behind in the reporting of side effects. According to a survey conducted by the Danish Medicines Agency, doctors say it is owing to lack of time, focus on the area and knowledge of the rules and procedures.
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25 September 2009 /Side effects and trials
European Medicines Agency recommends authorisation of two vaccines against influenza A (H1N1) 2009
The European Medicines Agency (EMEA) has recommended to the European Commission that two vaccines against influenza A (H1N1) be granted a marketing authorisation.
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25 September 2009 /About us
Danish-Chinese cooperation agreement
The Danish Medicines Agency today signed a memorandum of understanding in Copenhagen with its Chinese counterparty, the State Food and Drug Administration, P.R. China (SFDA).
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22 September 2009 /Authorisation and supervision
Medicines inspectors from 27 countries meet in Copenhagen on the use of blood, tissues and cells
This week, the Danish Medicines Agency is hosting an international conference that brings together specialists who carry out inspections of the use of human blood, tissues and cells at hospitals and in the pharmaceutical industry.
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08 September 2009 /Prices and reimbursement
Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)
On 3 september 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds).
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01 September 2009 /Side effects and trials
Changed rules for reporting side effects as of 1 September 2009
From now on, doctors, dentists and veterinarians nmust report all suspected serious adverse drug reactions to the Danish Medicines Agency no later than 15 days after they have to their attention.
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31 August 2009 /Side effects and trials
Beware of mix-ups between products containing mirtazapine and mianserin
The Danish Medicines Agency has been informed through the Danish Patient Safety Database of six adverse incidents in the period from March 2007 to June 2009 involving the mix-up of medicines containing the active substances mirtazapine and mianserin.
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27 August 2009 /Side effects and trials
Side effects from medicines used to prevent or treat influenza A (H1N1)
In here you will find the side effects from antiviral drugs such as Tamiflu® and Relenza® and the side effects from the vaccines for the prevention of influenza A (H1N1).
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26 August 2009 /Side effects and trials
About prevention and treatment of influenza
In Denmark, an influenza virus typically occurs every autumn or winter. If you have had the disease - or if you have been vaccinated against it - you will not catch it again the same year/season.
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26 August 2009 /Product information
Danish Medicines Agency hosts conference on biosimulation
Christiansborg Palace in Copenhagen sets the scene for a three-day conference where a group of leading scientists meet to take stock of recent years' progress of using computer modelling to develop medicines, an area also known as biosimulation.
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17 August 2009 | Updated 24 August 2009 /Side effects and trials
Contraceptive pills and the risk of blood clots
A new Danish study confirms that women taking contraceptive pills have an increased risk of blood clots compared to women who do not take contraceptive pills.
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04 August 2009 /Prices and reimbursement
Decision on the future reimbursement status of medicinal products in ATC group A08 (antiobesity preparations, excl. diet products)
On 3 July 2009, the Danish Medicines Agency made a decision on the future reimbursement status of medicinal products in ATC group A08 (antiobesity preparations excl. diet products).
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29 July 2009 /Side effects and trials
Update on the safety of insulin glargine (Lantus®)
Recently, the Danish Medicines Agency published a notification on its website on the possible link between treatment with insulin glargine (Lantus®) and the risk of cancer - breast cancer in particular.
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29 July 2009 /Side effects and trials
European Medicines Agency reviews data on vaccines against Influenza A (H1N1)
The European Medicines Agency (EMEA) has started to receive data from the pharmaceutical indsutry on vaccines against Influenza A (H1N1).
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24 July 2009 /Side effects and trials
Adverse reactions from Gardasil® in the period 1 January – 30 April 2009
The HPV vaccine Gardasil® has been introduced in the Danish childhood immunisation programme with the aim of preventing cervical cancer. For the first four months after the introduction Gardasil®, the Danish Medicines Agency received 191 adverse reaction reports describing 280 adverse reactions.
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03 July 2009 /Side effects and trials
Mandatory electronic submission of adverse reaction reports
The Danish Medicines Agency is always looking for ways to improve the processes of adverse reaction reporting. The vast majority of adverse reaction reports associated with medicinal products for human use are submitted electronically by the holders of marketing authorisations in compliance with the provisions of executive order no. 1214 of 7 December 2005 on requirements for the layout of adverse reaction reports and periodic safety update reports.
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01 July 2009 /Side effects and trials
Uncertainty about insulin glargine (Lantus®)
The Danish Medicines Agency has been made aware of four registry studies published on 29 June 2009 in the magazine Diabetologia at the website http://www.diabetologia-journal.org/cancer.html, which investigate a possible link between insulin glargine (Lantus®) and the risk of cancer/breast cancer.
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30 June 2009 /Authorisation and supervision
Compliance check of package leaflets and product labelling (spring 2009)
In response to complaints and reports, etc. submitted to the Danish Patient Safety Database, the Danish Medicines Agency has examined different elements of the labelling of the below listed medicinal products to find out whether they comply with the provisions of the executive order on labelling.
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30 June 2009 /Prices and reimbursement
Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C04 (Peripheral vasodilators)
At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group C04 (Peripheral vasodilators)
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30 June 2009 /Prices and reimbursement
Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC groups A04 (antiemetics and antinauseants) and A03FA (propulsives)
At the Danish Medicines Agency’s request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC groups A04 (antiemetics and antinauseants) and A03FA (propulsives).
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25 June 2009 /Side effects and trials
European Medicines Agency recommends withdrawal of dextropropoxyphene-containing medicines
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMEA) has recommended that all dextropropoxyphene-containing medicines be withdrawn from the market.
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25 June 2009 /Side effects and trials
EudraCT has been updated to version 7
On 19 June 2009, EudraCT was updated to version 7. Please visit EudraCT's website for an overview of the new functionality.
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19 June 2009 /Side effects and trials
Focus: Hospital doctors to report more side effects
In the past eight years, the number of side effects reported by hospital doctors each year has remained steady at approx. 600, despite a continued increase in medicine consumption and the fact that hospitals admit patients that receive more medicine than other patients.
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04 June 2009 /Prices and reimbursement
Reimbursement status of medicinal products in ATC groups A06 and A02AA04, laxatives: Consultation responses to the Reimbursement Committee's recommendation
The Reimbursement Committee's recommendation on the future reimbursement status of laxatives (ATC groups A06 and A02AA04) has been open for consultation until 27 May 2009.
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04 June 2009 /Prices and reimbursement
Reimbursement status of medicinal products in ATC groups A06 and A02AA04, laxatives: Consultation responses to the Reimbursement Committee's recommendation
The Reimbursement Committee's recommendation on the future reimbursement status of laxatives (ATC groups A06 and A02AA04) has been open for consultation until 27 May 2009.
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04 June 2009 /Prices and reimbursement
Reimbursement status of medicinal products in ATC group A08, antiobesity preparations, excl. diet products: Consultation responses to the Reimbursement Committee's recommendation
The Reimbursement Committee's recommendation on the future reimbursement status of antiobesity preparations, excl. diet products (ATC group A08) has been open for consultation until 25 May 2009.
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03 June 2009 /Side effects and trials
Potential risk of interaction between clopidogrel and proton pump inhibitors
The European Medicines Agency (EMEA) has raised concern about a possible risk of interaction between medicinal products that contain clopidogrel and proton pump inhibitors (PPI).
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14 May 2009 /News - miscellaneous
Medicines and weight loss
A number of medicines are available on the market for the treatment of life-threatening obesity. Most of these products are sold on prescription, but just recently a new medicine called Alli® was launched for over-the-counter sale.
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13 May 2009 /Side effects and trials
Research opens up questions about Botulinumtoxin A
In a new study in rats, scientists from the Italian Instituto di Neuroscienze in Pisa have discovered that Botulinumtoxin A injected into the jaw muscle of rats had found its way to the rats' brains three day after and that it was still present in the rats' brains after six months.
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11 May 2009 /Product information
Extended use of Tamiflu®
The European Medicines Agency, EMEA, has reassessed the use of Tamiflu® in pregnant women and infants who are ill with influenza A(H1N1).
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07 May 2009 /Product information
Warning on Hydroxycut pills
Stop using Hydroxycut pills, powder and capsules and talk to your doctor about possible side effects or symptoms of liver damage (jaundice, darkening of urine, nausea, vomiting, light-coloured stools, excessive fatigue, stomach or abdominal pain, itching and loss of appetite).
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06 May 2009 /Side effects and trials
Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications
The Voluntary Harmonisation Procedure is a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.
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04 May 2009 /Prices and reimbursement
Consultation on the reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)
At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)
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04 May 2009 /News - miscellaneous
Floods of spam e-mails mentioning swine flu
The computer security company McAfee has reported floods of spam e-mails that attempt to exploit people who worry about the swine flu.
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04 May 2009 /Product information
Alli® (orlistat) – over-the-counter weight-loss product
From today, pharmacies across Denmark will be offering the weight-loss product Alli®. Alli® contains the active ingredient orlistat, which has been authorised in Denmark and other EU countries since 1998 as a prescription-only weight-loss product.
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01 May 2009 /Retail and online sale
The pursuit of a better sex life can be detrimental to your health
It is easy to find and buy potency-enhancing pills on the internet. Unfortunately, many of them are not approved by the authorities. This means that they may be detrimental to your health.
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30 April 2009 /Prices and reimbursement
Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A08 (antiobesity preparations, excl. diet products)
At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group A08 (antiobesity preparations, excl. diet products).
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28 April 2009 /Retail and online sale
Tamiflu®: Beware of counterfeits!
As early as Saturdag, the first spam e-mails offering Tamiflu® were circulated, only shortly after the first reports on swine influenza in Mexico had reached the media.
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16 April 2009 /Side effects and trials
Side effects from Eltroxin® - status April 2009
Recently, the Danish Medicines Agency has recorded an increase in the number of reported side effects from Eltroxin. The increase is observed after GlaxoSmithKline (GSK) has changed the excipients contained in Eltroxin.
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03 April 2009 /Authorisation and supervision
The Danish Medicines Agency resumes the allocation of time slots for the first half of 2011
Until 16 December 2009, the Danish Medicines Agency accepts time slot requests for the first half of 2011 for DCP procedures with Denmark as Reference Member State (RMS)
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03 April 2009 /Product information
Withdrawal of the NES-Spacer® from AstraZeneca A/S
AstraZeneca has identified a problem with the NES-Spacer®, which is an inhalation device to be used together with asthma medicine. If a patient assembles the NES-Spacer® incorrectly, the patient cannot inhale the medicine, and the simultaneous use of a face mask prevents the patient from breathing.
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12 March 2009 /Authorisation and supervision
Project on the monitoring of compliance with the rules by manufacturers of active pharmaceutical ingredients
Since December 2005, active pharmaceutical ingredients (API) used in medicinal products with a marketing authorisation in Denmark have been required to be manufactured under the EU-GMP.
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11 March 2009 /Side effects and trials
No new adverse reactions suspected to be associated with the Gardasil® childhood vaccine
This is the statement of the Danish Medicines Agency following close scrutiny of all 174 reported adverse reactiong from the new HPV vaccine against cervical cancer - Gardasil®.
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25 February 2009 /Side effects and trials
The benefits of ADHD medicine exceed the risks
The benefits of the medicine exceed the risks when children and young people with activity and attention problems - ADHD (attention deficit hyperactivity disorder) - are given medicine containing the substance methylphenidate.
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23 February 2009 /Side effects and trials
The European Medicines Agency (EMEA) continues to recommend vaccination with Gardasil®
EMEA has reviewed two cases from Spain, where two girls experienced prolonged and severe seizures with loss of consciusness after they had been vaccinated with the cervical cancer vaccine Gardasil®.
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20 February 2009 /Side effects and trials
The European Medicines Agency (EMEA) recommends the European Commission to suspend the marketing authorisation of Raptiva®
The Committee for Medicinal Products for Human Use (CHMP) under EMEA has concluded that the benefit of the medicinal product Raptiva® (efalizumab) for patients with moderate plaque psoriasis can no longer justify the risk of a number of serious adverse reactions, first and foremost progressive multifocal leukoencephalopathy (PML)
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17 February 2009 /News - miscellaneous
Unchanged recommendations for menopausal hormone replacement therapy
On 14 January, the results of two scientific studies were published in the US journal Neurology. The studies examined the effect of so-called conjugated oestrogens on the brain in women above the age of 65.
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16 February 2009 /Side effects and trials
Atopic dermatitis and vaccination with Gardasil®
The HPV vaccine Gardasil® provides protection for cervical cancer. The vaccine has been on the Danish market since 2006. As of 1 January 2009, the vaccine is included in the Danish childhood immunisation programme as an offer for all 12-year-old girls.
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16 February 2009 /Retail and online sale
Campaign: Avoid dangerous weight-loss products on the internet!
Today, the Danish Medicines Agency launches a campaing against dangerous weight-loss products (containing e.g. ephedrine). The reason is that these products represent a major health risk to consumers and have already resulted in serious adverse reactions.
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16 February 2009 /News - miscellaneous
European cooperation on the replacement of animal testing with the PCR technique in the testing of veterinary vaccines
On 27-28 Ocotber 2008, the European Directorate for the Quality of Medicines & Healthcare (EDQM) held a meeting in Strasbourg on the use of the PCR (Polymerase Chain Reaction) technique in the testing of veterinary vaccines.
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03 February 2009 /Side effects and trials
The MRI contrast agent Dotarem®
Dotarem® is a gadolinium-containing contrast agent used in connection with MRI scanning. Gadolinium-containing contrast agents must be used with extreme care when scanning patients with renal impairment because these patients excrete the contrast agent significantly slower than patients with normal renal function.
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02 February 2009 /Prices and reimbursement
Consultation responses on the future reimbursement status of 5 combination products in ATC groups C07, C08 and C09
The Danish Medicines Agency's assessment of the future reimbursement status of 5 combination products in ATC groups C07, C08 and C09 for the treatment of cardiovascular diseases has been submitted for consultation with 11 December 2008 as the consultation deadline.
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16 January 2009 /Side effects and trials
The use of Omniscan for kidney patients
In February 2007, the Danish Medicines Agency changed its recommendations concerning the use of Omniscan for kidney patients due to a strong suspicion that the contrast medium may cause the serious adverse reaction: Nephrogenic Systemic Fibrosis
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15 January 2009 /About us
Organisational change at the Danish Medicines Agency
As of 1 January 2009, the Danish Medicines Agency implements an organisational change which entails that the Pharmacoeconomic Division will be closed down.
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13 January 2009 /News - miscellaneous
Medicine trials – fiction and reality
The Danish movie "Den Du Frygter" (The One You Fear), which premiered on 19 December, focuses on trials of medicine. The main character in the film participates in a trial that is cancelled due to dangerous side effects.
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13 January 2009 /Product information
Scabies medicine on its way to Denmark
The many cases of scabies all over Denmark has led to a lack of the medicine, Nix, which is authorised for scabies treatment in Denmark. In cooperation with the Assocation of Danish Pharmacies and the Danish Medicines Agency, the importer has come up with a solution which will ensure relief this week.
