News 2018

  • New report on adverse reactions reported with tramadol for pain relief

    | 20 December 2018 |

    The Danish Medicines Agency has received 830 reports of suspected adverse reactions with tramadol since the medicine was marketed in March 1993. 155 of them describe symptoms of dependence. This follows from a report that has just been published. In 2017, about 265,000 individuals received treatment with tramadol in Denmark.

  • New format requirements for Marketing Authorization submissions from 1 January 2019

    | 17 December 2018 |

    The NeeS submission format will be discontinued for all applications submitted under the national procedure (NP), i.e. applications for variations, renewals etc. This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.