DHPC – Nordimet® (Methotrexate)

Safety-related information for the product NORDIMET® Fertigpen (PEN)

26.09.2023
Product Nordimet, Injektionslösung im Fertigpen
Authorisation number 66568
Active substances methotrexatum
Marketing authorisation holder Nordic Pharma GmbH

The current packages on the Swiss market do not contain a recently approved Patient Information Leaflet. As a consequence a warning under section 2 of the leaflet is missing:

“If you, your partner or your caregiver notice new onset or worsening of neurological symptoms including general muscle weakness, disturbance of vision, changes in thinking, memory and orientation leading to confusion and personality changes contact your doctor immediately because these may be symptoms of a very rare, serious brain infection called progressive multifocal leukoencephalopathy (PML).”

Further information can be found in the information letter from the company.