News

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  • Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

    | 21 February 2017 |

    Takeda Pharma A/S recalls a batch of Pamol® in packs of 300 film-coated tablets after the discovery of Ibumetin 600 mg containing ibuprofen in some packs. Both types of medicine are used for the treatment of mild pain, but they work in different ways and may cause different adverse reactions.

  • New Q&A for clinical trial sponsors regarding contractual arrangements with vendors for electronic systems

    | 13 February 2017 |

    The Good Clinical Practice (GCP) inspectors of the EU member states have published a new Q&A based on the pitfalls for sponsors to be aware of regarding contractual arrangements with vendors for electronic systems in connection with clinical trials.

  • Denmark bids to host EMA headquarters in Copenhagen

    | 08 February 2017 |

    Today, the Danish Government officially announced its candidacy for hosting the European Medicines Agency (EMA) in Denmark.

  • Update on Europharma DK

    | 03 February 2017 |

    Europharma DK can now legally sell medicines repacked and released by Abacus Medicine.

  • Danish Pharmacovigilance Update, January 2017

    | 03 February 2017 |

    The January issue of Danish Pharmacovigilance Update.

  • We are extending our opening hours

    | 31 January 2017 |

    From Wednesday 1 February 2017, we are extending our opening hours. This means that the reception will be open Monday to Friday from 8.30am to 3.30pm. You can also call us on our main telephone number during these hours.

  • Updating of summaries of product characteristics due to changed ATC codes for 2017

    | 20 January 2017 |

    Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2017.

  • Danish Pharmacovigilance Update, December 2016

    | 06 January 2017 |

    The December issue of Danish Pharmacovigilance Update.

  • Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

    | 05 January 2017 |

    The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) will re-examine the decision to phase out medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs.

  • Suspension of Europharma DK ApS’ authorisation to manufacture and distribute parallel imported medicinal products

    | 03 January 2017 |

    Today, 3 January 2017, the Danish Medicines Agency suspended Europharma DK ApS’ authorisation number 30308 issued on 23 March 2015 for the manufacturing and import of medicinal products and intermediate products (GMP authorisation).

  • New chair of PhVWP-V

    | 20 December 2016 |

    Lisbet Vesterager Borge, veterinarian, has been elected chair of the European Pharmacovigilance Working Party Veterinary (PhVWP-V).

  • Zinc oxide for young pigs to be phased out

    | 19 December 2016 |

    The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

  • The Danish Medicines Agency launches new strategy

    | 15 December 2016 |

    The Danish Medicines Agency: Among Europe's best in class! This is our vision and we are now launching a strategy for how we are going to achieve the vision.

  • Phasing-out of the NeeS format for applications for marketing authorisations of medicinal products

    | 12 December 2016 |

    Due to an increasing number of requests, we would like to point out the phasing-out plan for NeeS and the transition to eCTD/VNeeS as outlined in the eSubmission Roadmap. The format requirements apply to applications for marketing authorisations for medicinal products as well as maintenance of these (variations, renewals etc.). The changes do not apply to parallel import and parallel distribution.

  • Danish Pharmacovigilance Update, November 2016

    | 09 December 2016 |

    The November issue of Danish Pharmacovigilance Update.

  • Interactive Adverse Drug Reaction overviews

    | 08 December 2016 |

    The Danish Medicines Agency has launched a new web-based database that researchers and other interested parties can use to search for reported suspected adverse reactions.

  • Twelve new substances on the list of euphoriant substances

    | 30 November 2016 |

    As of 24 November 2016, 12 new substances are included in the Danish executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health. The information is primarily relevant to companies authorised to deal with euphoriant substances.

  • How the HPV vaccine works

    | 30 November 2016 |

    The Danish Medicines Agency has made a short video graphic about the efficacy of the HPV vaccine.

  • Nikolai Brun appointed new Director of Division

    | 24 November 2016 |

    The Danish Medicines Agency strengthens its leadership team and appoints Nikolai Brun, MD and PhD, as Director of Division of the new Medical Evaluation & Biostatistics division.

  • Danish Pharmacovigilance Update, October 2016

    | 15 November 2016 |

    The October issue of Danish Pharmacovigilance Update.

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