News

  • Danish Pharmacovigilance Update May 2014

    | 14 July 2014 |

    In the May issue of Danish Pharmacovigilance Update: Assessment of risk of serious anaphylactic reactions from treatment with ferumoxytol (Rienso), ADR reports for the HPV vaccine and the Danish Health and Medicines Authority’s annual pharmacovigilance report 2013.

  • Monitoring of medicines for births

    | 07 July 2014 |

    The Danish Health and Medicines Authority has prepared a midterm review of the activities in the action plan for Danish regions' use of medicines for the induction of labour. The action plan was launched in the autumn of 2013 following a public debate about the use of these medicines, and it should be completed by the end of 2015.

  • More clinical trials to Denmark

    | 03 July 2014 |

    The number of clinical trial applications increased by 35 trials (14%) from 2012 to 2013, which is the highest level in seven years. The increase covers both companies and researchers according to the Danish Health and Medicines Authority's annual report 2013 on clinical trials of medicines in humans.

  • Focus on correct dose of Pro-Epanutin

    | 24 June 2014 |

    The Danish Health and Medicines Authority encourages hospitals to pay special attention to the risk of dose errors of the anticonvulsant medicine Pro-Epanutin.

  • Falsified cancer medicine not distributed in Denmark

    | 10 June 2014 |

    Falsified batches of the cancer medicine Herceptin® from Roche have been identified in England, Germany and Finland. None of the affected batches have been distributed in Denmark.

  • Amendment of executive order on euphoriant substances 30 May 2014

    | 03 June 2014 |

    On 30 May 2014, the substances below were included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health.

  • Regulation on clinical trials on medicinal products adopted

    | 03 June 2014 |

    The European Commission's proposal for new European legislation on clinical trials of medicinal products was adopted in early 2014. The objective is to promote the number of clinical trials in the EU.

  • More than 10,000 websites shut down in global operation

    | 28 May 2014 |

    The recent global Operation PANGEA VII resulted in the shutdown of more than 10,000 websites. The operation focused on combating online sale of counterfeit medicines and making consumers aware that they need to take care of themselves when buying medicines online. Globally, the operation led to 237 arrests, some 540,000 parcels were inspected and over 9.4 million units containing potentially life-threatening medicines were seized – worth an estimated value of more than USD 35 million. More than 10,000 websites were shut down or had their payment facility removed.

  • Updated guidelines on requirements for the QP in a pharmaceutical company

    | 09 May 2014 |

    The Danish Health and Medicines Authority has updated the guidelines on requirements and expectations for the qualified person (QP) in a pharmaceutical company. The requirements for the QP have not been changed compared to the previous guidelines. The new guidelines have mainly been updated to include the requirements for the duration of the QP's education as specified in the applicable directives. In addition, a number of other updates and specifications have been made that you can read more about in this news item.

  • Danish Pharmacovigilance Update 30 April 2014

    | 07 May 2014 |

    In the April issue of Danish Pharmacovigilance Update:

  • Guidance material to doctors and users of contraceptive pills

    | 06 May 2014 |

    The EU Pharmacovigilance Risk Assessment Committee (PRAC) recently completed a review of the risk of blood clots (VTE) with contraceptive pills and other combined hormonal contraceptives. Combined hormonal contraceptives contain two types of hormone, oestrogen and progesterone, and are available as pills, transdermal patches and vaginal rings.

  • 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

    | 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.

  • Danish Pharmacovigilance Update 27 February 2014

    | 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).

  • 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.

  • 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.

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