Italian Medicines Agency Agenzia Italiana del Farmaco

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Direct communication with healthcare professionals on supply shortage Zypadhera

Zypadhera is in shortage since 2024. The shortage concerns all strengths of the medicine < 210 mg / 300 mg / 405 mg > and is expected to last until October 2025.

The shortage was initially due to manufacturing problems with the 50 mm needle supplied with the medicine.

The shortage has worsened due to additional manufacturing and supply chain problems, and a quality defect which led to particles in two batches of the medicine.

The affected batches were not released on the market.

The shortage affects all EU/ EEA countries where the product is marketed.

Healthcare professionals are advised to not prescribe Zypadhera to new patients to reserve / guarantee supply for patients who are already taking this medicine and who do not have suitable alternatives and to safely transfer patients to alternative theraphy, if switching existing patients from Zypadhera to another antipsychotic.

Background on the shortage  
Zypadhera is indicated for the maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine. It has been authorised in the EU since November 2008 and is available as a 210 mg, 300 mg and 405 mg powder and solvent for prolonged release suspension for injection.


Published on: 22 August 2025

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