DKMA Update December 2017

09 January 2018

In this issue of DKMA Update, you can read about the new medicinal cannabis pilot programme, about how to read the summary of product characteristics, and about two new studies on the use of contraceptive pills and adverse reactions.

This newsletter features the following articles:

  • Happy New Year from the Danish Medicines Agency
  • Summary of product characteristics – read it right
  • Medicinal cannabis pilot programme from the new year
  • Clarithromycin and cardiac events
  • Two new studies on the use of contraceptive pills and adverse reactions
  • New study on hydrochlorothiazide and the risk of skin cancer
  • Prolonged-release paracetamol withdrawn from the market
  • Marketing authorisation for certain gadolinium-containing contrast agents is suspended
  • Examination of the prostate cancer drug Xofigo initiated by EMA
  • When pharmaceutical companies in third countries fail to comply with GMP
  • Antibiotic recalled due to increased levels of histamine
  • Great turnout at the Danish Medicines Agency’s information meetings about new medical devices regulations
  • OTC medicines in the self-selection area
  • New rules for the issuance of prescriptions
  • Most recent Direct Healthcare Professional Communications (DHPCs)


DKMA update, number 3, December 2017 (PDF)