DKMA Update December 2018

Updated 23 January 2019

This newsletter features the following articles:

Editorial

  • The safety of medical devices is strengthened

Latest news about medicines safety and medical devices

  • Further restrictions on the use of valproate
  • Risk of suicide to be reflected in the product information of contraceptive pills
  • Restricted use of antibiotics with quinolones and fluoroquinolones is advised
  • Stricter dose warning on the package of the arthritis and psoriasis medicine methotrexate
  • New biosimilar medicines for Humira

An insight into the work of the Danish Medicines Agency in 2018

  • New growth plan boosted the Danish Medicines Agency’s ambition to join Europe’s best in class
  • Danish Medicines Agency part of inspection agreement between EU and the USA in 2018
  • Concerted campaign on safe online shopping received with great interest
  • Impurities found in several batches of blood pressure lowing medicine valsartan
  • A Danish registry study found a small increased risk of two forms of cancer with the use of hydrochlorothiazide
  • High turnout for theme events at the Danish Medicines Agency
  • Tonnes seized in global operation against illegal online sale of medicines
  • Danish Medicines Agency strengthened its international collaboration
  • Danish Medicines Agency represented at World Economic Forum
  • Top marks for the Danish Medicines Agency in European survey
  • Danish Medicines Agency launched a new concept for national scientific advice
  • Work began on a new register of medicinal products to benefit patient safety
  • Major efforts for safer prescription of blood thinning medicines
  • Better conditions for clinical trials in Denmark
  • European top post for Thomas Senderovitz
  • Medicinal cannabis pilot programme entered into force

Two projects with focus on companies

  • Pharmaceutical companies must ensure people have access to package leaflets on www.indlaegsseddel.dk
  • Major European review of the subdivision of tablets

Short news

  • New front page for our website
  • Brexit page on the website of the Danish Medicines Agency
  • Major international focus on the reporting of suspected adverse reactions
  • Thank you for your cooperation and dedication in 2018

Link

DKMA Update December 2018 (pdf)

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