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18 February 2011 /News - miscellaneous
Age limit of 18 years introduced for buying painkillers
As of 7 March 2011, young people under the age of 18 will only be allowed to buy painkillers at a pharmacy, and only on prescription from a doctor.
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18 February 2011 /Side effects and trials
Possible connection between narcolepsy and the influenza vaccine Pandemrix® requires further studies
At present, there are not sufficient data to establish whether or not there is a connection between the sleep disorder narcolepsy and the influenza vaccine Pandemrix®, so concludes the European Medicines Agency (EMA) in a press release today.
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15 February 2011 /Prices and reimbursement
Applications for general reimbursement in 2010
In 2010, the Danish Medicines Agency reviewed 21 cases on general reimbursement for medicines. Nine medicines were granted general reimbursement or general conditional reimbursement, and the remaining 12 medicines were refused general reimbursement, one of which maintained general conditional reimbursement.
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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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08 February 2011 /News - miscellaneous
Medicine and mainstreaming
We invite you to a symposium on medicine and gender mainstreaming Tuesday 22 February 2011 from 15.30 to 17.00 at the Danish Medicines Agency, Axel Heides Gade 1, DK-2300 Copenhagen S.
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04 February 2011 /Authorisation and supervision
Licensing of medicines – prioritisation and forecast processing times for the first half of 2011
Every six months, we prioritise and forecast processing times for the authorisation of medicines. Our prognosis for the first half of 2011 and status on the second half of 2010 are now ready.
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02 February 2011 /Prices and reimbursement
Review concluded regarding general reimbursement for Palexia Depot®
The Danish Medicines Agency has completed its review of an application for general reimbursement for Palexia Depot®. The product has been granted general reimbursement.
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02 February 2011 /Side effects and trials
Increased risk of narcolepsy from the influenza vaccine Pandemrix®
A study from Finland shows that the sleep disorder, narcolepsy, could be linked to the influenza vaccine Pandemrix®. In the period 2009-2010, 60 Finnish children and adolescents aged 4-19 years fell ill with narcolepsy, and 52 of them had received the Pandemrix® vaccine. Similar cases of narcolepsy from use of Pandemrix® have also been observed in Sweden and Iceland, but not elsewhere in Europe.
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31 January 2011 /About us
Welcome to our new website
Our website laegemiddelstyrelsen.dk (dkma.dk) has been redesigned with a new look, a new and improved content structure as well as more accurate and relevant search results. The goal has been to develop an appealing and more logical website where you can find what you are looking for quickly.
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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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25 January 2011 /Side effects and trials
EMA changes domain name 7 February 2011
Please note that, as part of the European Medicines Agency’s domain name change from 'EMEA’ to 'EMA’, adverse reaction reporting systems will need to be updated in order to still send E2B files.
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24 January 2011 /Side effects and trials
Information for doctors and dialysis patients regarding peritoneal dialysis solutions from Baxter A/S
As announced previously, there is presently an increased risk that peritoneal dialysis patients could develop aseptic peritonitis (inflammation of the peritoneum). Doctors and patients should still be alert to symptoms suggestive of aseptic peritonitis and should report any cases of aseptic peritonitis in peritoneal dialysis patients.
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17 January 2011 /Side effects and trials
No acknowledgement message is currently dispatched when companies submit electronic adverse reaction reports
Since Thursday 13 January, the Danish Medicines Agency has experienced problems with dispatching acknowledgement messages (ACKs) for electronic adverse reaction reports submitted by companies. We are doing all we can to solve the problem fast so that we can send the ACKs that are awaiting.
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11 January 2011 /Prices and reimbursement
Reassessment of reimbursement status of medicines for treatment of depression and anxiety disorders
On 22 December 2009, the Danish Medicines Agency announced that it would begin reassessing the reimbursement status of medicines in ATC group N
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04 January 2011 /News - miscellaneous
Avoid dangerous weight-loss products
The Danish Medicines Agency once again puts focus on the risk of weight-loss products containing the active substances ephedrine, rimonabant and sibutramine - weight-loss products that have not been authorised by the authorities.
