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18 April 2011 /Side effects and trials
Bisphosphonates may cause atypical fractures
Treatment with bisphosphonates may cause atypical fractures of the femur – especially in patients who have received long-term treatment for osteoporosis; concludes the European Medicines Agency, EMA, on the basis of a review it recently completed.
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11 April 2011 | Updated 18 April 2011 /Side effects and trials
Report side effects from medicines, herbal medicines and food supplements
At the Danish Medicines Agency, we receive reports of side effects from doctors, medicine users and relatives. You can report side effects from any type of medicines and herbal medicines, and it is of no importance whether you bought the product over the counter or on prescription.
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15 April 2011 /Side effects and trials
EMA recommends interim changes to the summary of product characteristics of Pandemrix®
The European Medicines Agency, EMA, recommends that the product information for the influenza vaccine Pandemrix® should be amended to advise prescribers to weigh the benefits against the risks when considering the medicine for a child or adolescent.
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05 April 2011 | Updated 14 April 2011 /Side effects and trials
Danish hospitals are stepping up side effect reporting
As a result of the Danish Medicines Agency’s campaign “React when serious and unexpected side effects occur”, hospital doctors have more than ever contributed with information and thus given us a better basis to regularly assess the safety of the medicine on the market: Hospital doctors have put more focus on identifying and reporting side effects, and the number of reports submitted by hospitals across Denmark has increased on average.
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12 April 2011 /Side effects and trials
Implementation of MedDRA version 14.0
MedDRA is updated every six months, and on 1 March 2011, MedDRA version 14.0 was released. Therefore, MedDRA version 14.0 will be implemented the night before Monday 2 May 2011.
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05 April 2011 /Side effects and trials
Cases of narcolepsy in adolescents after vaccination with Pandemrix® in France
The French medicines agency (Afssaps) has announced that they have received more reports of the sleep disorder narcolepsy than expected, among adolescents aged 10 to 15 who have received the influenza vaccine Pandemrix®. The French health authorities consider it to be a slight signal of possible problems with Pandemrix®, which is still watched closely.
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01 April 2011 /Side effects and trials
Companies' (MAH) handling of adverse reaction reports received via E2B from the Danish Medicines Agency
When the Danish Medicines Agency sends adverse reaction reports via E2B to marketing authorisation holders (MAHs), it sometimes happens that an MAH returns the adverse reaction report to Danish Medicines Agency via E2B.
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01 April 2011 /Side effects and trials
Public access to EU clinical trials register
The register will, in time, cover all clinical trials in the EU, Iceland, Norway and Liechtenstein. The register provides knowledge about purpose and content of the thousands of ongoing or completed trials in Europe.
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28 March 2011 | Updated 01 April 2011 /Side effects and trials
Reports of blood clots from the use of Vivaglobin®
The Danish Medicines Agency has been made aware of a few post-marketing reports of severe cases of blood clots associated with the use of Vivaglobin® manufactured by CSL Behring. None of the reports are from Denmark.
