Novo Nordisk SpA, in agreement with the European Medicines Agency and the Italian Medicines Agency, would like to inform you of the following:

Summary:

• A manufacturing issue caused some vials of NovoSeven® 1mg and 2mg to be potentially under-filled, causing the reconstituted final product, to be of lower concentration. This issue affected some products manufactured for Spain, Italy, Latvia, Czechia, Lithuania and Austria. The manufacturing issue has now been resolved.
• This manufacturing issue, combined with release delays from the packaging line and continued capacity constraints which are not related to the manufacturing issue, is expected to cause intermittent shortages of NovoSeven® in all authorized and marketed dosages, at least throughout 2024.
• In a shortage situation, Healthcare Professionals (HCPs) should ensure that patients using NovoSeven® are safely switch to an available alternative strength until supply is restored or to suitable alternatives, if appropriate, based on their clinical judgment and according to the local label recommendations.