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29 July 2009 /Side effects and trials
Update on the safety of insulin glargine (Lantus®)
Recently, the Danish Medicines Agency published a notification on its website on the possible link between treatment with insulin glargine (Lantus®) and the risk of cancer - breast cancer in particular.
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29 July 2009 /Side effects and trials
European Medicines Agency reviews data on vaccines against Influenza A (H1N1)
The European Medicines Agency (EMEA) has started to receive data from the pharmaceutical indsutry on vaccines against Influenza A (H1N1).
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24 July 2009 /Side effects and trials
Adverse reactions from Gardasil® in the period 1 January – 30 April 2009
The HPV vaccine Gardasil® has been introduced in the Danish childhood immunisation programme with the aim of preventing cervical cancer. For the first four months after the introduction Gardasil®, the Danish Medicines Agency received 191 adverse reaction reports describing 280 adverse reactions.
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03 July 2009 /Side effects and trials
Mandatory electronic submission of adverse reaction reports
The Danish Medicines Agency is always looking for ways to improve the processes of adverse reaction reporting. The vast majority of adverse reaction reports associated with medicinal products for human use are submitted electronically by the holders of marketing authorisations in compliance with the provisions of executive order no. 1214 of 7 December 2005 on requirements for the layout of adverse reaction reports and periodic safety update reports.
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01 July 2009 /Side effects and trials
Uncertainty about insulin glargine (Lantus®)
The Danish Medicines Agency has been made aware of four registry studies published on 29 June 2009 in the magazine Diabetologia at the website http://www.diabetologia-journal.org/cancer.html, which investigate a possible link between insulin glargine (Lantus®) and the risk of cancer/breast cancer.
