The Italian Medicines Agency, in agreement with the Marketing authorization holder/ dealer Viatris Italia s.r.l., would like to inform you of the following:

Due to production problems/high demand, for medicines containing pancrelipase as active substance:

• Creon® (pancrelipase) 10.000 Ph.Eur. units modified-release hard capsules 100 capsules (MA n. 029018064);
• Creon® (pancrelipase) 25.000 Ph.Eur. units modified-release hard capsules 100 capsules (MA n. 029018049);
• Creonipe® (pancrelipase) 35.000 Ph.Eur. units gastro-resistant hard capsules 100 capsules (MA n. 047002098) a quota distribution is applied and this situation will presumably last until 31/12/2025.

The shortage is not related to safety or quality issues and has been already notified to the competent authority, according to the current legislation.

Professional healthcares should be aware of this shortage and should prescribe Creon 10.000 Ph.Eur. units and 25.000 Ph.Eur. units and Creonipe 35.000 Ph.Eur units only for authorized indications, made aware patients already undergoing treatment of the above also in order to avoid hoarding phenomena, prescribe Creon 10.000 Ph.Eur. units and 25.000 Ph.Eur. units and Creonipe 35.000 Ph.Eur units only if strictly necessary, in the minimum effective dose, and if for the above-mentioned indication there are no valid therapeutic alternatives or if, for patients under treatment, it is not possible to switch to other medicines.