News items 2015
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Paracetamol use during pregnancy
| 27 February 2014 |
A new Danish study suggests a possible connection between mothers' use of paracetamol painkillers during pregnancy and the risk of developing disorders like ADHD (attention deficit hyperactivity disorder) in children.
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EMA recommends further restrictions on the use of the osteoporosis medicine strontium ranelate (Protelos®)
| 25 February 2014 |
The European Medicines Agency (EMA) recommends to restrict the use of the osteoporosis medicine strontium ranelate (Protelos®) to patients with severe osteoporosis who cannot be treated with other medicines approved for osteoporosis.
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Danish Pharmacovigilance Update 19 December 2013
| 17 February 2014 |
In this issue of Danish Pharmacovigilance Update: Patients with mechanical heart valves should not be treated with the new oral anticoagulants Pradaxa®, Xarelto® and Eliquis®.
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Guidelines on applications for authorisation to wholesale distribute medicines within the EU/EEA
| 12 February 2014 |
The Danish Health and Medicines Authority has updated the Guidelines on applications for authorisation to wholesale distribute medicines within the EU/EEA.
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The common portal for clinical trial applications on DKMAnet still postponed
| 10 February 2014 |
We plan to launch DKMAnet for clinical trial applications to both the research ethics committees and the Danish Health and Medicines Authority in the first half of 2014.
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Danish Pharmacovigilance Update 28 November 2013
| 03 February 2014 |
In this issue of Danish Pharmacovigilance Update: Ciprofloxacin and the risk of tendon disorders, risk of blood clots from the use of the cancer medicine ponatinib and reporting of adverse reactions to the Danish Health and Medicines Authority.