Publications about side effects and product information

  • Annual pharmacovigilance report 2015

    | 25 April 2016 |

    Openness and dialogue are keywords in the Danish Medicines Agency's work with adverse reactions. In 2015, this was to become particularly important. Since 2009, almost 2,000 girls and young women had reported suspected adverse reactions to the Gardasil® HPV vaccine, and patient organisations and the media wanted us to join the debate.

  • Guide to individual case safety reporting

    | 26 June 2015 |

    We have prepared a guide to pharmaceutical companies about the exchange of individual case safety reports to and from the Danish Health Authority. The guide is in English and includes recommendation

  • Annual Pharmacovigilance Report 2014

    | 08 May 2015 |

    In 2014, the number of adverse drug reaction (ADR) reports in the Danish adverse reaction database came close to 100,000. The ADR reports go as far back as the late 1960s when the first national system for registration of adverse reactions was established.

  • Annual pharmacovigilance report 2013

    | 30 June 2014 |

    In 2013, the Danish Health Authority, DHMA, received the highest number of adverse reactions ever. A total of 6681 adverse reactions were reported to us, which is 35% more than the year before. The boost in reports is attributable to several aspects. A number of targeted campaigns have put increased focus on the area, but also the development and implementation of better IT services have made it easier to report adverse drug reactions (ADRs). Especially the HPV vaccine against cervical cancer got a lot of attention in 2013 and accounted for a large proportion of the ADR reports.

  • Annual pharmacovigilance report 2012

    | 07 August 2013 |

    In the Danish Health Authority's (DHMA's) annual pharmacovigilance report, you can read about some of the pharmacovigilance work performed by the DHMA in 2012.

  • Adverse drug reaction reports (ADRs) from consumers may improve patient safety

    | 20 March 2013 |

    In a report, the DHMA has reviewed the ADR reports received during the years 2003–2011 to clarify how consumer reports differ from reports from healthcare professionals.

  • Danish Medicines Agency's annual pharmacovigilance report 2011

    | 01 August 2012 |

    The annual pharmacovigilance report offers an insight into some of the pharmacovigilance work performed by the Danish Medicines Agency in 2011.

  • Publication on medicines most frequently involved in serious adverse drug events

    | 12 October 2011 |

    A new study carried out by a working group associated with the Danish Medicines Agency's network "Prevention of Medication Errors" has shown that it is more or less the same groups of medicines that have been involved in the so-called adverse events from the 1970s and up until today. Based on the study, we have drawn up two lists of medicines that appear in high-risk situations – sorted by active substance and medicine group. The Danish Medicines Agency and the working group behind the study hope that these lists can become an important tool in the daily work with risks in the medication process in the health sector.

  • Danish report on treatment with SSRI antidepressants

    | 27 September 2011 |

    Based on a debate about the safety of treatment with SSRI antidepressants, the Danish Medicines Agency has drawn up an overview report. The report aims to provide healthcare professionals and others involved in SSRI treatment with an overview of our current knowledge about the consumption of SSRIs and the safety of this type of medicine. The main focus of the report is on the safety of SSRIs and the risk of adverse reactions in foetuses and newborns of mothers who have used SSRI antidepressants.

  • Danish Medicines Agency’s annual pharmacovigilance report 2010

    | 20 June 2011 |

    In 2010, primarily the Danish Minister for the Interior and Health’s action plan to improve monitoring of side effects marked the work in the pharmacovigilance area. The action plan was launched in 2009 in cooperation with the Council for Adverse Drug Reactions and was fully implemented in 2010. The annual report offers an insight into much of the pharmacovigilance work performed by the Danish Medicines Agency in 2010.

  • Assessment of safety of methylphenidate in ADHD treatment

    | 29 October 2010 |

    The Danish Medicines Agency has reviewed the data on consumption and side effects of methylphenidate-containing medicine, which is authorised for the treatment of ADHD and narcolepsy.

  • Danish Medicines Agency’s annual pharmacovigilance report 2009

    | 29 March 2010 |

    The annual report offers an insight into the pharmacovigilance work performed by the Danish Medicines Agency in 2009.

  • Report assessing the EU system monitoring medicinal product safety

    | 21 March 2006 |

    In 2004, the EU Commission decided to launch an assessment of the existing system for monitoring of medicinal products, primarily to enable an assessment of the need for potential and possible improvements.

Did you get answers to your questions?

Please tell us how we can improve our website?