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29 January 2010 /Side effects and trials
Side effects from Pandemrix® from 9 to 22 January 2010
In the period from 9 to 22 January 2010, the Danish Medicines Agency received 28 new side effect reports covering a total of 63 suspected side effects (adverse reactions).
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29 January 2010 /Product information
Warning against pills from IDS Sports
The Danish Medicines Agency and the Danish Veterinary and Food Administration warn against use of the Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs and Ripped Tabs TR.
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27 January 2010 /Retail and online sale
Updated warning against counterfeit Alli® from the USA
In continuation of the Danish Medicines Agency's warning on 19 January 2010 against counterfeit versions of the weight-loss product Alli®, the Danish Medicines Agency would like to bring attention to the latest information on the counterfeit product.
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26 January 2010 /Authorisation and supervision
New practice for authorisation of contract acceptors on section 39 authorisations
On 1 February 2010, a new practice will apply to the authorisation of contract acceptors on authorisations granted pursuant to section 39 of the Danish Medicines Act (a section 39 authorisation).
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26 January 2010 /Prices and reimbursement
Change of the content of the fields ’Number of DDD per package’ and ’Price per DDD’
Users of ftp.dkma.dk, www.medicinpriser.dk and www.erhverv.medicinpriser.dk should note that the content of two fields in the LMS files at ftp.dkma.dk changed on 16 November 2009.
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26 January 2010 /News - miscellaneous
Vacancy for an Executive Director of the European Medicines Agency
The European Medicines Agency (EMA) is looking for an Executive Director to lead and manage the Agency and take overall responsibility for its operations, thus ensuring achievement of the Agency's objectives.
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22 January 2010 /Side effects and trials
European Medicines Agency recommends suspension of marketing authorisations for sibutramine due to increased risk of cardiovascular events
Sibutramine is a medicine used to promote weight loss, which has been marketed in Denmark since 2001 under the name Reductil®.
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19 January 2010 /Retail and online sale
Warning against counterfeit Alli® from the USA
The Danish Medicines Agency warns any consumers who have purchased the weight-loss product Alli® via American websites of the risk that the product may be counterfeit, and that the counterfeit version contains an active substance not listed on the package.
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15 January 2010 /Side effects and trials
Side effects from Pandemrix® from 19 December 2009 to 8 January 2010
In the period from 19 December 2009 to 8 January 2010, the Danish Medicines Agency received 32 new side effect reports covering a total of 73 suspected side effects (adverse reactions).
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08 January 2010 /Side effects and trials
Minutes of the Pharmacovigilance Working Party's meeting held on 21-23 September.
The Pharmacovigilance Working Party (PhVWP) under EMEA's Committee for Medicinal Products for Human Use (CHMP) held its September 2009 plenary meeting on 21-23 September 2009.
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07 January 2010 /Side effects and trials
Side effects from Eltroxin® - status January 2010
The Danish Medicines Agency has recorded an increase in the number of reported side effects from Eltroxin®. The increase is observed after the manufacturer changed the excipients contained in Eltroxin®.
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07 January 2010 /Prices and reimbursement
The Danish Medicines Agency initiates the reassessment of reimbursement status of medicines in ATC group N
The Danish Medicines Agency initiates its reassessment of the reimbursement status of medicines in ATC group N (Nervous system). It will take place concurrently with the reassessment process for the remaining subgroups in ATC groups A and J.
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04 January 2010 /Side effects and trials
Side effects from Pandemrix® from 12 to 18 December 2009
In the period from 12 to 18 December, the Danish Medicines Agency received 48 new side effect reports covering a total of 121 suspected side effects (adverse reactions).
