News about Licensing and supervision

  • Withdrawal of a batch of EpiPen® 300 micrograms

    | 17 March 2017 |

    MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.

  • EuropharmaDK regains its authorisation

    | 13 March 2017 |

    The Danish Medicines Agency has decided to lift the suspension of EuropharmaDK's manufacturing and importation authorisation, following the outcome of a follow-up inspection of EuropharmaDK ApS on 8 March where the Danish Medicines Agency ascertained that the critical findings had been corrected.

  • New transatlantic agreement on mutual recognition of inspections

    | 03 March 2017 |

    The EU and the USA have agreed to recognise inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic.