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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.
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15 August 2007 /Retail and online sale
Sale of stop-smoking aids at restaurants and cafés
Since 15 October, restaurants and cafés have had the opportunity to sell stop-smoking aids, e.g. nicotine chewing gum and nicotine patches.
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01 August 2007 /Side effects and trials
Guideline for first-in-man clinical trials
EMEA has published a guideline for first-in-man clinical trials.
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29 June 2007 /Retail and online sale
Thresholds for the total amount of active substance in certain medicinal products sold in general sales outlets
In Denmark, it is permitted to sell certain over-the-counter medicinal products in non-pharmacy outlets (these products fall within dispensing group HF).
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19 June 2007 /Authorisation and supervision
New regulations for advanced therapy medicinal products, tissue engineering
The Council and the European Commission have approved a number of new proposals from the European Parliament for a regulation on advanced therapy medicinal products, including 'tissue engineering'.
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19 June 2007 /Prices and reimbursement
The fixed price system for medicinal products for production animals is abolished
On 2 April 2007, the sale of veterinary medicinal products for production animals became liberaliser. This entails an amendment of a number of executive orders on reporting and notification of information from the retailers to the Danish Medicines Agency in relation to these medicinal products.
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06 June 2007 /Side effects and trials
The Danish Medicines Agency monitors adverse reactions
During the first two years of a medicinal product's life on the market, adverse reactions are monitored closely. Doctors must report adverse reactions.
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06 June 2007 /Retail and online sale
Counterfeit versions of the medicinal product Zyprexa® found in Great Britain
The British Medicines and Healthcare products Regulatory Agency (MHRA)today issued a drug alert in response to finding of counterfeit versions of the medicinal product Zyprexa® (olanzapine) 10mg tablets in the UK supply chain.
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06 June 2007 /Retail and online sale
Counterfeit versions of the medicinal products Plavix® and Casodex@ found in Great Britain
The British Medicines and Healthcare products Regulatory Agency (MHRA) has issued drug alerts in response to findings of counterfeit versions of the medicinal products Plavix® (clopidogrel) 75 mg tablets and Casodex® (bicalutamide) in the UK supply chain.
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23 May 2007 /Authorisation and supervision
Import of medicinal products to be sold or dispensed according to a compassionate use permit
The Danish Medicines Agency would like to specify the rules on release and distribution of medicinal products imported into Denmark from countries outside the EU/EFA (third countries) with the object of selling or dispensing the products according to a compassionate use permit.
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23 May 2007 /Prices and reimbursement
Reassessment of the reimbursement status of blood pressure products resumed in the Reimbursement Committee
At its meeting on 12 December 2006, the Reimbursement Committee resumed the reassessment of the reimbursement status of blood pressure products.
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01 May 2007 /Authorisation and supervision
Warning: Unauthorised sale of donated sperm from the sperm bank A.I. Sædbank
The Danish Medicines Agency has become aware that the sperm bank A.I. Sædbank sells donated sperm via its. website: www.saedbank.com. The sperm bank is not authorised by the Danish Medicines Agency and therefore the sale of the sperm from the website is unlawful.
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20 April 2007 /Retail and online sale
Warning: Counterfeit versions of the medicinal product Tertensif® found in Bulgaria
Counterfeit versions of the medicinal product Tertensif® (indapamide) 1.5 mg enteric-coated tablets have been found at pharmacies and distributors on the Bulgarian market.
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02 April 2007 /Retail and online sale
Warning: Counterfeit Xenical® sold via the internet
On the website www.europharmacies.com, a Norwegian consumer has ordered the prescription-only medicinal product Xenical® (orlistat). A subsequent analysis has shown that the product is a counterfeit version of the original medicinal product Xenical®.
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29 March 2007 /Prices and reimbursement
New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007
As of 23 April 2007, the reimbursement status of lipid lowering medicinal products will be changed. The decision includes all lipid lowering medicinal products with marketing authorisations in Denmark on 15 March 2007.
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26 March 2007 /Retail and online sale
Warning: Counterfeit Cipralex® found in Egypt
Counterfeit versions of the medicinal product Cipralex® (Escitalopram) 10 mg tablets, 28 pieces in blister packs have been found at a pharmacy in Egypt.
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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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27 February 2007 /Retail and online sale
Changed basic range of over-the-counter medicinal products
The Danish Medicines Agency has changed the basic range of the over-the-counter medicinal products from 16 to 9 over-the-counter products. The basic range has been changed based on studies of the liberalisation of over-the-counter medicinal products showing that some products are hardly sold at all, such as nicotine patches.
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26 February 2007 /Prices and reimbursement
Electronic notification of medicinal product prices
The Danish Medicines Agency starts to receive only electronic notifications of medicinal product prices and product ranges via our secure, access-restricted extranet DKMAnet - Prices & Packages during 2007.
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15 February 2007 /Prices and reimbursement
Reassessment of reimbursement status of medicinal products in ATC-groups A01, A04, C04, C05 and C10
In connection with the reassessment of the reimbursement status of medicinal products, the Reimbursement Committee discussed the reimbursement status of certain ATC groups at its meeting on 16 January 2007.
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08 February 2007 /Side effects and trials
New recommendations on the use of MRI contrast agents in patients with impaired renal function
The CHMP-Pharmacovigilance Working Party has considered the safety of gadolinium-containing MRI contrast agents. The Committee has concluded that the recommendations on the use of these contrast agents should be amended for patients with impaired renal function.
