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28 October 2009 /Side effects and trials
Adverse reactions from Gardasil® in the period 1 May – 31 August 2009
In the period May-August, the Danish Medicines Agency received 69 reports describing 145 suspected adverse reactions. The majority of the reports are not seroius, and the majority (two thirds) of the side effect are already known and described in the summary product characteristics.
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23 October 2009 /Side effects and trials
One dose of Pandemrix® against influenza A (H1N1)v for healthy adults
The Danish National Board of Health has changed its recommendation to one dose of Pandemrix® vaccine against influenza A (H1N1) for healthy adults who are offered the vaccine.
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22 October 2009 /Side effects and trials
Changed definition of safe contraception in clinical trials
We have updated section 5.1 Contraception in the Guideline for applications for authoristaion of clinical trials of medicine product in humans.
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14 October 2009 /Side effects and trials
EU Commission authorises a third vaccine against influenza A (H1N1)
The European Commission has authorised the use of Celvapan® (Baxter) as a vaccine against influenza A (H1N1). The authorisation follows last week's recommendation by the European Medicines Agency (EMEA) to the European Commission to grant a marketing authorisation for the vaccine.
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14 October 2009 /Side effects and trials
Side effects from Eltroxin® - status October 2009
The Danish Medicines Agency has recorde an increase in the number of reported side effects from Eltroxin®. The increase is observed after GlaxoSmithKline (GSK) has changed excipients contained in Eltroxin®.
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06 October 2009 /Side effects and trials
The European Medicines Agency recommends authorisation of another vaccine for pandemic influenza A (H1N1)
The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA) recommends that a marketing authorisation be granted for a third vaccine pandemic influenza A (H1N1).
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05 October 2009 /Prices and reimbursement
Decision on future reimbursement status for medicinal products in ATC group C04 (peripheral vasodilators)
On 21 September 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group (peripheral vasodilators).
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02 October 2009 /Authorisation and supervision
Control of Granocyte®
The Danish Medicines Agency has analysed two different batches of Granocyte for the presence of the active substance lenograstim.
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02 October 2009 /Authorisation and supervision
Control of Neupogen® and Neupogen Novum®
The Danish Medicines Agency has analysed three different batches of Neupogen and Neupogen Novum for the presence of the active substance filgrastim.
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02 October 2009 /Prices and reimbursement
Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C05 (Vasoprotectives)
At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group C05 (Vasoprotectives).
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01 October 2009 /Side effects and trials
EU Commission authorises two vaccines against influenza A (H1N1)
The EU Commission has authorised the use of two vaccines against influenza A (H1N1). The vaccines concerned are Focetria® (Novartis) and Pandemrix® (GlaxoSmithKline), and Pandemrix® is the one that will be used in Denmark.
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01 October 2009 /Retail and online sale
Warning: Counterfeit Viagra® sold on Danish website
The Danish Medicines Agency strongly warns against buying Viagra® on the Danish-language website www.6medicin.com/www.6medicin.dk. Analyses carried out by Pfizer (which manufactures genuine Viagra®) have proven that the Viagra® packages sold on www.6medicin.com/www.6medicin.dk are counterfeit. They are not manufactured by Pfizer.
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01 October 2009 /News - miscellaneous
Information regarding medicines containing dibutyl phthalate
The Danish Medicines Agency is presently reviewing which medicines containing dibutyl phthalate (DBP) are still on the Danish market.
