The European Pharmacovigilance Working Party, PhVWP, has drawn up a recommendation for the wording of the product information concerning Stevens-Johnson syndrome and toxic epidermal necrolysis for high risk medicines:
- allopurinol
- carbamazepine
- lamotrigine
- phenobarbital
- phenytoin
- sulfamethoxazole
- sulfasalazine
- sulfadiazine
- sulfafurazole
- sulfadoxine
- meloxica
- piroxicam
- tenoxicam
- nevirapine.
The Danish Medicines Agency has now translated this recommendation into Danish.
The text is used to prepare new product information. Furthermore, marketing authorisation holders of the above medicines must implement the new text by submitting variation applications for all relevant products.
The translation as well as other Danish translations of PhVWP recommendations for the wording of product information are available in the box to the right.
