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04 June 2008 /Authorisation and supervision
Updating of Danish QRD templates for summaries of product characteristics and package leaflets
On the EMA website, you can find the QRD templates that the industry must use to draw up summaries of product characteristics and package leaflets.
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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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15 May 2008 /Authorisation and supervision
Warning about unauthorised distribution of donated sperm from the sperm bank A.I. Sædbank
The Danish Medicines Agency has previously warned againts the sperm bank A.I. Sædbank, which unlawfully sells donated sperm from its website.
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30 April 2008 /Retail and online sale
Warning: Counterfeit packages of Cipralex® found in Pakistan
The Danish Medicines Agency has been made aware that the counterfeit Cipralex® packages have been found in pharmacies in Pakistan. The counterfeit version of Cipralex®, 10mg, pack size 14 tablets, looks like the original packages, yet there are certain differences between the counterfeit and original version.
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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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28 April 2008 /Side effects and trials
Tests completed for heparin products on the Danish market
Pfizer has now tested the remaining nine Fragmin® batches which the Danish Medicines Agency instructed Pfizer to withdraw from the market yesterday.
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28 April 2008 /Side effects and trials
EMEA's Committee for Human Medicinal Products reviews heparin issues
The EMEA's Committee for Human Medicinal Products (CHMP) is reviewing issues related to the treatment with and supply of heparin products.
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24 April 2008 /Side effects and trials
Analysis of heparin products on the Danish market
All heparin products on the Danish market have been tested for the impurity oversulfated chondroitin sulfate (OSCS). The products were tested after it came out that the use of heparin products (most of which are produced by the American company Baxter) has caused some serious adverse reactions in the US.
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24 April 2008 /Side effects and trials
Use of angiotensin II receptor antagonists during pregnancy – updated product information
The European Medicines Agency (EMEA) has recommended that the product information of all angiotensin II receptor antangonists authorised via the EU centralised procedure be harmonised, regarding their use during pregnancy.
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22 April 2008 /Side effects and trials
Report on the contrast medium Omniscan®
On 22 February, the Danish Minister for Health and Prevention requested the Danish Medicines Agency to prepare a report on Omniscan®. This report has been submitted to the Ministry of Health and Prevention.
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22 April 2008 /Side effects and trials
Significant increase in adverse reactions reported by consumers
As in previous years, the vast majority of adverse reactions are reported by the medical profession, however figures from 2207 alone point to a significant increase in the share of adverse reactions reported by consumers compared with the year before.
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17 April 2008 /Side effects and trials
The cough remedy Dexofan®
On Tuesday 15 April 2008, Danish TV2 Praxis is running a feature on the cough remedy Dexofan®. Dexofan® is a cough remedy sold over the counter in tablet form or as a mixture.
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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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11 April 2008 /Authorisation and supervision
Control of medicinal product labelling (spring 2008)
The Danish Medicines Agency has examined the medicinal products shown in this text to see whether the labelling complied with section 7 of the Executive Order on Labelling which stipulates that the labelling of a medicinal product must not be misleading or give rise to mix-ups between medicinal products, pharmaceutical forms or strengths.
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03 April 2008 /Side effects and trials
EMEA recommends new contraindication for Velcade® (bortezomib)
The European Medicines Agency (EMEA) has recommended that Velcade® (bortezomib) should not be used in patients with certain severe lunge or heart problems (acute diffuse infiltrative pulmonary and pericardial disease).
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03 April 2008 /Side effects and trials
EMEA investigates potential risk of heart attack in HIV infected patients treated with abacavir
The European Medicines Agency (EMEA) has reviewed data from the so-called D:A:D (Data collection of Adverse effects of anti-HIV Drugs) study, which suggested an increased risk of heart attack (myocardial infarction) associated with the use of abacavir-containing medicine.
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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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28 March 2008 /Side effects and trials
Recall of specific heparin batches
Since the beginning of the year, the US Food and Drug Administration (FDA) has recorded an increasing number of reported adverse drug reactions - some 800 reports, of which 19 involved deaths in patients - from the use of heparin.
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27 March 2008 /Side effects and trials
Sclerosis medicine may cause liver injury
New reports have shown that the sclerosis medicine Tysabrin® (natalizumab) may cause liver injury. Sclerosis patients who receive Tysabri® are therefore urged to see their doctor if they develop symptoms of liver problems.
