Danish translation of the PhVWP's recommendation for the product information of methotrexate

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for methotrexate.

The Danish Medicines Agency has now translated this recommendation into Danish: Oral methotrexate – assessment of potential fatal overdose due to medication error (PDF, 0.19 MB)

The text is used to prepare new product information. Furthermore, marketing authorisation holders of methotrexate must implement the new text by submitting variation applications for all relevant products.