In view of an unprecedented increase in demand for insulin products of the Sanofi Group and the inability to immediately increase supply capacity, the Marketing Authorisation Holder, Sanofi Winthrop Industrie, has decided on the temporary marketing cessation of Insulin Lispro Sanofi 100 units/ml in the pre-filled pen and cartridge presentations.

The temporary marketing cessation is not related to any safety, efficacy, or quality concerns of the medicinal product.

Insulina Lispro Sanofi (100 units/ml) solution for injection in vial is at the moment not impacted.

With regard to the situation in Italy, the temporary marketing cessation is currently scheduled as follows:

• Pre-filled pen – cartridge in pre-filled pen (Solostar) – 3 ml (3.5 mg/ml), 5 pre-filled pens (MA no. 045481052): temporary marketing cessation expected from 28 February 2026;
• Cartridge - 3 ml (3.5 mg/ml), 5 cartridges (MA no. 045481013): temporary marketing cessation expected from 30 September 2026.

At present, it is not possible to define a date for the resumption of marketing.

During the period of temporary marketing cessation, healthcare professionals should not initiate new patients on the affected presentations and should ensure a timely and safe transition of patients currently treated to appropriate therapeutic alternatives. In particular, patients may be switched to alternative insulin lispro-containing products or to products containing other rapid-acting insulin analogues (e.g., insulin aspart or insulin glulisine)., based on clinical judgment and in accordance with the recommendations set out in the Summary of Product Characteristics and the guidance of the competent authorities.