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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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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.
