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FAMHP (Belgian Medicine Agency) · Belgium · Supply notice

Improved availability of Zypadhera powder and solvent for prolonged release suspension for injection: relaxation of restrictions and updated recommendations

AI-generated summary

Zypadhera (olanzapine prolonged release injection) availability has improved since 2024, and distribution restrictions are being gradually relaxed from 1 January 2026. Specialist physicians may resume initiating treatment for new patients and restart patients who switched to alternatives, while considering other therapeutic options. Prescriptions should limit dispensing to one-month supplies to prevent stockpiling. Pharmacies, hospitals, and patients are advised not to accumulate stock, with priority maintained for institutional facilities.

Dates and deadlines
Applies from
1 Jan 2026
From FAMHP (Belgian Medicine Agency)

Since 2024, Zypadhera (powder and solvent for prolonged release suspension for injection) has been subject to limited availability. Availability has since improved. Therefore, distribution restrictions have been be gradually and carefully relaxed since 1 January 2026. The FAMHP Task Force Unavailability issues recommendations with a view to further easing.

Recommendations for physician (specialists)

- Specialist doctors may, taking into account the improved availability, once again initiate treatment with Zypadhera for new patients. When starting treatment, they should consider possible therapeutic alternatives, including oral olanzapine, another oral antipsychotic, or other prolonged release products such as risperidone, paliperidone, or aripiprazole.

- Patients who switched to another medicinal product during the period of limited availability can be restarted on Zypadhera when this is clinically indicated.

- It is recommended that prescriptions for Zypadhera be issued in such a way that patients can collect only a one month supply at a time. When multiple prescriptions are issued, the start date of validity of each prescription should be aligned with monthly dispensing to avoid collecting larger quantities at once.

- Inform patients about the importance of not stockpiling.

Recommendations for pharmacies open to the public

- Dispense to each patient only the quantity needed for a maximum of one month.

- Deliveries to prisons, orthopaedagogical centres, psychiatric centres and residential care homes remain a priority.

- Inform patients about the importance of not stockpiling.

- Do not build up stock. Available quantities are sufficient to meet urgent needs but do not allow stockpiling at different levels.

Recommendations for hospital pharmacists

Adjust orders to actual needs and avoid unnecessary stockpiling. Available quantities are sufficient to meet urgent needs but do not allow stockpiling at different levels.

Recommendations for patients

- Since January 2026, you can again collect your medicinal product from a pharmacy open to the public.

- If you switched to another medicinal product during the period of limited availability, your doctor can assess whether restarting Zypadhera is appropriate for you.

- We ask you not to build up stock, so that Zypadhera remains available for all patients. The situation continues to be closely monitored. By remaining attentive together, we can help ensure that further easing measures remain possible.

- Your doctor will write your prescriptions so that you can collect only a one month supply at a time. You may also receive multiple prescriptions, with start dates aligned to the different collection moments.

Monitoring and communication

The FAMHP is closely monitoring the situation and planned deliveries and remains in regular contact with the members of the Task Force Unavailability, the company, the distribution partner and the European Medicines Agency (EMA).

Contact

supply-problems@fagg-afmps.be

Excerpt from the official page. The original is authoritative.