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  • The online register is unstable

    | 25 April 2014 |

    Our online register for registered healthcare professionals is currently unstable. We are working to resolve this issue.

  • Danish Pharmacovigilance Update 29 January 2014

    | 14 April 2014 |

    In this issue of Danish Pharmacovigilance Update

  • Danish Pharmacovigilance Update 27 March 2014

    | 10 April 2014 |

    In this issue of Danish Pharmacovigilance Update

  • Medicinal use of cannabis

    | 19 December 2013 | Updated 08 April 2014 |

    The Danish Health and Medicines Authority has prepared a memo about the Danish experiences with and rules applicable to medicinal use of cannabis.

  • The seven roles of physicians

    | 04 April 2014 |

    Last year, the Danish Health and Medicines Authority revised the descriptions of the seven physician roles used in medical specialist training so that they match the future work of physicians. The rep

  • Danish Pharmacovigilance Update 27 February 2014

    | 06 March 2014 | Updated 01 April 2014 |

    In this issue of Danish Pharmacovigilance Update: Further restrictions on the use of osteoporosis medicine strontium ranelate (Protelos®), Anticoagulant therapy to be stopped before initiating treatment with the new oral anticoagulants (NOACs).

  • The health of Danes combined in unique database

    | 13 March 2014 |

    The Danish Health and Medicines Authority and Danish Regions have published new figures for the health of the adult population in Denmark.

  • Danish Pharmacovigilance Update 31 October 2013

    | 05 March 2014 |

    In this issue of Danish Pharmacovigilance Update: The risk of blood clots from the use of contraceptive pills is low regardless of type, Report of cardiac arrest in association with the use of flecainide (Tambocor®).

  • 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.

  • Updating of summaries of product characteristics due to changed ATC codes for 2014

    | 15 January 2014 | Updated 26 February 2014 |

    Marketing authorisation holders of medicinal products authorised under the Decentralised Procedure and the Mutual Recognition Procedure should be aware that some ATC codes have been changed in 2014.

  • 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.

  • 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®.

  • 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.

  • 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.

  • 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.

  • Information to MAHs for new combined hormonal contraceptives

    | 29 January 2014 |

    After the most recent EU review of a number of new combined contraceptives under Article 31 of Directive 2001/83/EC, it was decided that marketing authorisation holder (MAHs) for these products must send out DHPCs and guidance material to doctors.

  • Recommendations for organ donation

    | 28 January 2014 |

    More people should decide whether they wish to become a potential organ donor and the hospitals should introduce pathways. These are two of the recommendations of a working group headed by the Danish Health and Medicines Authority that has made recommendations for an action plan to increase the number of organ donors.

  • Time slots for DCP procedures with Denmark as Reference Member State (RMS)

    | 28 January 2014 |

    The Danish Health and Medicines Authority wishes to inform future applicants of the possibility to request for a time slot to applications for marketing authorisations through the decentralised procedure (DCP) where Denmark is acting as reference member state (RMS).

  • Questions and answers to new good distribution practice guidelines

    | 27 January 2014 |

    The guidelines on good distribution practice of medicinal products for human use came into force on 7 September 2013. Read our questions and answers to the guidelines.

  • Reimbursement of medicines bought in another EU/EEA country

    | 14 January 2014 | Updated 16 January 2014 |

    From 1 January 2014, you can obtain reimbursement of prescription-only medicines bought in another EU/EEA country under the general reimbursement rules of the Danish Health Act. You have to be covered by the national health insurance in Denmark and have a health insurance card (the yellow card) and the medicine must be reimbursable in Denmark.