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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.
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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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17 March 2008 /Side effects and trials
Assessment of gadolinium-containing MRI contrast mediums - current status
Follow-up on previous announcements. In the spring of 2006, the Danish Medicines Agency initiated an investigation by the EU Pharmacovigilance Working Party of the safety of gadolinium-containing MRI contrast mediums in kidney patients.
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05 March 2008 /Side effects and trials
The Danish Medicines Agency suspends marketing authorisation for Somadril® (carisoprodol)
The Danish Medicines Agency has decided to suspend the marketing authorisation for the medicinal product Somadril® with effect from 2 June 2008.
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22 February 2008 /Side effects and trials
The MRI contrast medium Omniscan®
The 18:30 television news, TV Avisen, of 21 February 2008 carried a story about the MRI contrast medium Omniscan®. We have previously placed information about this substance on our website.
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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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14 February 2008 /Prices and reimbursement
Reassessment of reimbursement status for medicinal products for the treatment of cardiovascular diseases
Following a request from the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status for medicinal products authorised for marketing in Denmark in ATC groups C02 (antihypertensives), C03 (diuretics), C07 (beta blocking agents), C08 (calcium channel blockers) and C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors).
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07 February 2008 /Side effects and trials
The Danish Medicines Agency warns against using skin lightening creams containing corticosteroids
The Danish Medicines Agency has been made aware that the skin lightening cream containing corticosteroids can be bought from ethnic shops and via the internet.
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30 January 2008 /News - miscellaneous
Nordic Market for Medicinal Products
Availability of medicinal products in small markets is an issue that has been repeatedly on the agenda of EEA countries. A Nordic working group has therefore been formed to explore the possibilities of a common Nordic market for medicinal products.
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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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29 January 2008 /Side effects and trials
Treatment of haemangioma with interferon
Over recent days, the Danish Media has drawn attention to several incidents where interferon treatment of haemangioma (strawberry marks) in children is suspected to have caused spastic paralysis affecting the legs in children.
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24 January 2008 /Side effects and trials
Statement from EMEA regarding the safety of Gardasil®
The European Medicines Agency (EMEA) has received reports of deaths in women who had previously received Gardasil®, including two reports concerning the sudden and unexpected deaths of two young women in EU.
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11 January 2008 /Side effects and trials
Use of waivers in connection with the inclusion of trial subjects/patients in clinical trials
The EMEA GCP Inspectors Working Group has prepared a document with a common European position on the use of waivers in connection with the inclusion of trial subjects/patients in clinical trials.
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11 January 2008 /Side effects and trials
Reflection paper from EMEA's GCP Inspectors Working Group on expectations for electronic source documents used in clinical trials
The EMEA GCP Inspectors Working Group has prepared a reflection paper on the handling of electronic documents in connection with clinical trials.
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10 January 2008 /Authorisation and supervision
New rules governing advanced therapy medicinal products
The proposed regulation on advanced therapy medicinal products, including tissue engineered products, was announced on the Danish Medicines Agency's website on 12 June 2007.
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10 January 2008 /Authorisation and supervision
General principles of the regulation on advanced therapy medicinal products
Regulation (EC) No 1394/2007 on advanced therapy medicinal products specifically governs gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineered products.
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09 January 2008 /Side effects and trials
Safety regarding use of corticosteroids
Synthetic corticosteroids are used to treat a variety of disesaes. For some reason, some patient cannot produce the vital corticosteroid hormone (cortisol) naturally, and they therefore need to be given this hormone.
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25 October 2007 /Authorisation and supervision
New application forms for the authorisation of manufacture, import and wholesale distribution of medicinal products
The Danish Medicines Agency has published new application forms for authorisation of companies to manufacture, import and wholesale distribute medicinal products (authorisation under section 39 of the Danish Medicines Act, see the factbox to the right).
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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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21 August 2007 /Retail and online sale
Major increase in medicinal products seized by customs
The volume of counterfeit medicinal products seized by EU customs controls has increased dramatically in 2006 according to a report from the European Commission.
