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15 January 2013 /Product information
Updating of summary of product characteristics prompted by changed ATC codes for 2013
We advise marketing authorisation holders of medicinal products authorised under the Decentralised Procedure and the Mutual Recognition Procedure that some ATC codes have changed in 2013.
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17 August 2012 /Product information
Do not use Spektramox 50 mg/ml +12.5 mg/ml with batch numbers 96629 and 96630
There is a risk that plastic pieces could be present in Spektramox 50 mg/ml + 12.5 oral solution with batch numbers 96629 and 96630, and consumers in Denmark who, during the past seven days, have received this product should return it to a pharmacy for replacement.
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19 March 2012 /Product information
New contraindications and update of warning for the use of Protelos®
Protelos® is no longer recommended for use in immobilised patients or patients with venous thromboembolism, and the product information will therefore be updated.
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23 January 2012 /Product information
Danes can now look up medicines on their mobiles
In Denmark, people can now check medicines via a new free app for mobile phones. The app is called 'Medicintjek', which literally means medicine check, and it's available for download on iPhone and Android mobiles. It is a service offered free of charge by the Danish Medicines Agency for anyone interested.Through one single entry point, Medicintjek gives access to information in Danish from the websites medicinpriser.dk, medicinkombination.dk, indlaegsseddel.dk and laegemiddelstyrelsen.dk, which are all run by the Danish Medicines Agency.
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13 January 2012 /Product information
Warning against Green Coffee 800
A slimming coffee that could give serious side effects because it contains the active substance sibutramine has been sold from a Danish website, which has now been closed. We warn Danish consumers against using the product due to the risk of side effects.
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12 January 2012 /Product information
Dangerous medicine concealed in weight-loss products
Warning against unauthorised weight-loss medicine in juice, tea, coffee, etc. In the past year, the Danish Medicines Agency has noted an increase in unauthorised products that contain the active substance sibutramine. It is included in a variety of products such as tea, coffee, milkshake and juice. Often, there is no way of telling from the products that they contain sibutramine.
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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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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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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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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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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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24 March 2011 /Product information
Limited availability of Thyrogen® (thyrotropin alfa) until July 2011
The Danish Medicines Agency and the manufacturer of Thyrogen® have advised the European Medicines Agency (EMA) that Thyrogen® will be in limited supply until July 2011.
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24 February 2011 | Updated 07 March 2011 /Product information
Spirocort®/Pulmicort pressurised inhalers 100 µg/dose and 200 µg/dose will disappear from the Danish market
The manufacturer of Spirocort® / Pulmicort ceases production permanently, and it is therefore expected that Spirocort® / Pulmicort pressurised inhalers, 100 µg/dose as well as 200 µg/dose, will be in short supply within a few months.
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14 February 2011 /Product information
Gadolinium-containing MRI contrast agents and risk of nephrogenic systemic fibrosis (NSF)
Following a recent European review, the summaries of product characteristics for gadolinium-containing products are to be updated and harmonised, so that the information is the same throughout the EU.
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31 January 2011 /Product information
Potential contamination of alcohol preparation pads, swabs and swabsticks manufactured by Triad Group in the USA
The Danish Medicines Agency warns about potential contamination of prep pads, swabs and swabsticks with the bacteria ‘Bacillus cereus’.
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14 December 2010 /Product information
Warning against dangerous "natural" potency-enhancing product
The Danish Medicines Agency strongly warns against using the potency-enhancing product marketed as POWERtabs based on information from the Norwegian drug regulatory authorities that a Norwegian man needed treatment after having taken the potency-enhancing product.
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22 October 2010 /Product information
Important information for diabetics: GlucaGen® Hypokit 1 mg for injection recalled in Denmark
Novo Nordisk A/S in Denmark is recalling a defective batch of GlucaGen® Hypokit, which is used to treat severe hypoglycaemia (low blood sugar) in diabetes.
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26 July 2010 /Product information
EMA reassesses cardiovascular safety of rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim)
In July, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) once again initiated a review of the benefit-risk profile of rosiglitazone-containing medicines, which in Denmark are used to a very limited degree for the treatment of type 2 diabetes.
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22 July 2010 /Product information
Updated monographs for Heparin calcium (0332) and Heparin sodium (0333) for implementation in the European Pharmacopoeia (Ph. Eur.) as of 1 August 2010
As a follow-up on the work on improving the analysis methods for potentially contaminated heparin preparations, the European Pharmacopoeia Commission has adopted two revised monographs for Heparin calcium (0332) and Heparin sodium (0333) which will be implemented in the European Pharmacopoeia (Ph. Eur.) from 1 August 2010.
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26 March 2010 /Product information
EMA recommends recall of clopidogrel products from Acino Pharma GmbH
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has been made aware of quality problems with the manufacturing process at the factory which supplies the active substance for the manufacturing of eight clopidrogel-containing products.
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11 March 2010 /Product information
Strengthened warning against Alscreme 'Creme nr. 2' from www.eminescu.dk
On 12 February 2010, the Danish Medicines Agency warned strongly against using the product Alscreme 'Creme nr. 2' sold via www.eminescu.dk, as the product is an unlicensed medicinal product that contains active substance clobetasol.
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03 March 2010 /Product information
Updating of summary of product characteristics prompted by changed ATC codes for 2010
Marketing authorisation holders of medicinal products authorised under the Decentralised Procedure and the Mutual Recognition Procedure should be aware that som ATC codes have been changed in 2010.
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16 February 2010 /Product information
Warning against ‘Alscreme Creme nr. 2’ from www.eminescu.dk
The Danish Medicines Agency warns strongly against use of the product 'Alscreme Creme nr. 2' sold via www.eminescu.dk, as the product is an unauthorised medicinal product containing the active substance clobetasol.
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29 January 2010 /Product information
Warning against pills from IDS Sports
The Danish Medicines Agency and the Danish Veterinary and Food Administration warn against use of the Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs and Ripped Tabs TR.
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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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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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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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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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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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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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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.
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19 September 2008 /Product information
National meeting about the Pharmaceutical Forum held 12 September 2008
On 12 September 2008, the Danish Medicines Agency hosted a national meeting about the Pharmaceutical Forum held by the Danish Ministry of Health and Prevention and the Danish Medicines Agency.
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12 September 2008 /Product information
Withdrawal of the asthma and lung medicine Oxis Turbohaler® with batch no. IA763-3
2care4 has, in cooperation with the Danish Medicines Agency, chosen to withdraw Oxis Turbohaler® with batch no. IA763-3 from Danish pharmacies. The company has chosen to do so because of the risk that packages in this batch may contain turbohalers with the wrong dose relative to the strength stated on the package.
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27 August 2008 /Product information
Thalidomide Pharmion (thalidomide) on the Danish market as of 25 August 2008
Thalidomide Pharmion is authorised in the EU as first line treatment of multiple myeloma, which is a relatively rare cancer of the bone marrow. Thalidomide Pharmion must be given in combination with the medicines melphalan and prednisone.
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11 August 2008 /Product information
Warning against the product Melanotan
The Danish Medicines Agency has been made aware of the product, Melanotan, which is sold via the internet. The product is marketed as a product that increases pigmentation, providing tanned skin and protection against the harmful rays of the sun, implying that it may prevent skin cancer. However, this effect has not been documented.
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25 July 2008 /Product information
EMEA recommends restricting the use of oral moxifloxacin-containing medicines
The European Medicines Agency (EMEA) has reviewed the safety of moxifloxacin-containing medicines for oral use. The EMEA has concluded that these medicines should only be prescribed for the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed.
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25 July 2008 /Product information
EMEA recommends restricted use of oral norfloxacin-containing medicines in urinary infections
The European Medicines Agency has recommended restricting the use of oral norfloxacin-containing medicines in urinary infections.
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25 July 2008 /Product information
No increased risk of developing cancer for patients having taken Viracept® contaminated with ethyl mesilate
Following a review of a number of toxicology studies, the European Medicines Agency (EMEA) has confirmed that there is no increased risk of development of cancer for patients who have taken contaminated Viracept® (Nelfinavir).
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15 July 2008 /Product information
Warning against the product Viamax Energizer
The Danish Medicines Agency has become aware of the product Viamax Energizer, which is sold on the internet as a product providing energy. An analysis carried out by the Swedish Medical Products Agency has shown that the product contains the active substances levodopa and theophylline, which does not appear from the packages.
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03 July 2008 /Product information
Recall of Nobligan® oral drops in Denmark
In cooperation with the Danish Medicines Agency, Grünenthal Aps has decided to recall all packs of Nobligan® oral drops, 100mg/ml (pack sizes of 10 ml and 96 ml) in Denmark.
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04 June 2008 /Product information
EMEA recommends changes in the storage conditions for Neupro® (rotigotine)
The European Medicines Agency (EMEA) has recommended the immediate implementation of changes to the product information for Neupro® (rotigotine), from Schwarz Pharma Ltd., stating that it must be stored in a refrigerator (at a temperature of between 2ºC and 8ºC).
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27 May 2008 /Product information
Danish Medicines Agency warns against the weight-loss product Therma Power
The Danish Medicines Agency strongly warns against Therma Power Red and similar products with the same content and characteristics. Therma Power Red contains ephedrine and is illegal in Denmark.
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30 April 2008 /Product information
Warning against the product Wodibo
The Danish Medicines Agency has been made aware of the Chinese potency-enhancing product, Wodibo, which is sold via the internet. Wodibo is not a licensed medicinal product, and we therefore warn against using it.
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17 April 2008 /Product information
Dexofan® is made prescription-only
Today, the Danish Medicines Agency passed a decision to clasify Dexofan® as a prescription-only medicine in dispensing group A on recommendation by the Licensing Committee.
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03 April 2008 /Product information
Warning against vpxl N°1 Dietary Supplement for Men
The medicines authorities in Luxembourg have found a product that contains the active substance tadalafil, which did not appear from the packages. The product concerned is vpxl N°1 Dietary Supplement for Men, which is sold on the internet.
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18 March 2008 /Product information
Warning about Power 1 Walnut
The Danish Medicines Agency has been made aware that the Health Sciences Authority in Singapore has confiscated large quantities of the illegal medicinal product Power 1 Walnut, which has been marketed as a potency-enhancing product containing only herbs.
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22 February 2008 /Product information
Warning against the products Herb Vigour, China Vigour and Natural Vigour
The Danish Medicines Agency has been made aware that the products Herb Vigour, China Vigour and Natural Vigour are being sold on the Danish langauge version of www.eco-herbs.com.
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30 January 2008 /Product information
The Danish Medicines Agency and the Danish Veterinary and Food Administration warn against the weight loss product Therma Power
The Danish Medicines Agency strongly warns against Therma Power and products with a similar content and characteristics. Therma Power contains ephedrine or synephrine and is illegal in Denmark.
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19 October 2007 /Product information
Warning: Illegal sibutramine-containing weight-loss products sold on the internet
The illegal Chinese weight-loss products LiDa (DaiDaiHuaJioaNang) and Miaozi are being sold on the internet, e.g. at the Danish language version of www.hurtigslank.dk (www.fastslim.dk).
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07 March 2007 /Product information
Warning against the product Prostasol with oestrogen
The Danish Medicines Agency has become aware that the product Prostasol, which is sold via foreign websites, contains oestrogen without this appearing from the packet.
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07 November 2006 /Product information
Warning against the Malaysian product Libidus with the substance vardenafil
The Canadian pharmaceutical authorities - Health Canada - have found a product containing the active substance vardenafil without this being indicated on the packets.
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11 August 2006 /Product information
Chinese products containing tadalafil, sildenafil and sibutramine
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has found four products containing the active substances tadalafil, sildenafil or sibutramine without this appearing on the packets.
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26 July 2006 /Product information
Kamagra tablets with sildenafil
The medicinal product Kamagra is sold on several internet pages. Kamagra tablets contain the active substance sildenafi, which is normally used for treatment of erectile dysfunction.
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21 April 2006 /Product information
Warning: Illegal copies of medicinal products with the active substance rimonabant sold on the internet
Illegally copied medicinal products, which apparently contain the active substance rimonabant, are sold at several websites. Rimonabant has been developed for treatment of obesity, but it has not yet been authorised for sale.
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21 April 2006 /Product information
Warning: Sale of illegal diet pills
Illegal diet pills containing the active substances ephedrine and ephedra are sold in a number of shops and on the internet. The illegal products are sold under names such as Therma Power
