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22 February 2011 /Authorisation and supervision
Information on extended deadline for implementation of updates to labelling and package leaflets for variations
In October-November 2010, the Danish Medicines Agency opened a consultation on a proposal to extend the deadline for implementation of updates to labelling and package leaflets for variations. We now publish a consultation note (in Danish only) and describe the next steps in implementing the extended deadline for implementation.
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22 February 2011 /Prices and reimbursement
Review concluded regarding general reimbursement for Sycrest®
The Danish Medicines Agency has completed its review of an application for general reimbursement for Sycrest®. The product has been granted general reimbursement.
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22 February 2011 /Prices and reimbursement
Review concluded regarding general reimbursement for Targin®
The Danish Medicines Agency has completed its review of an application for general reimbursement for Targin®. The product is neither eligible for general nor general conditional reimbursement.
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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.
