Zypadhera - supply shortage

Ongoing

olanzapine

Shortage information

There is a shortage of Zypadhera in the EAA (European Economic Area).

Zypadhera is a medicine used to maintain the improvement of symptoms in patients with schizophrenia who have already been stabilised on an initial course of olanzapine taken by mouth.

For further information on the use of the medicine please refer to the medicine’s overview page.

Reason for shortage

In 2024, there was a shortage of Zypadhera due to manufacturing problems with the 50 mm needles supplied with the medicine for injection. This issue has now been resolved.

However, the shortage persists. The company for Zypadhera is now experiencing additional manufacturing problems and a quality defect, which have led to further disruptions. The batches affected by the quality defect were not distributed to the market. 

Member States affected

Critical shortages of Zypadhera affect most Member States where the product is marketed and are expected to last until October 2025.

This information may change. For up-to-date information about the status of a medicine shortage in a particular Member State, consult the national shortage register or contact the national competent authority.

Monitoring of shortage

EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC – working party) are closely monitoring the supply situation and engaging with the marketing authorisation holder and national competent authorities to mitigate the impact of the supply shortage.

Based on this coordinated approach, the company for Zypadhera has taken the following actions to improve the situation:

• increase manufacturing shifts at the manufacturing site;
• implement changes to solve and prevent quality defects;
• reallocate stocks within the EU and worldwide in a fair and equitable manner.

Recommendations for healthcare professionals

• There are shortages of Zypadhera in most countries of the EEA. They may affect one or more strengths of the medicine and are expected to last until October 2025.
• No other injectable olanzapine medicine is available in the EEA.
• A medicine shortage communication (MSC) has been sent to healthcare professionals in affected Member States. The MSC provides important information on the shortage and guidance on managing patients during this period.
• For additional information, consult your country’s shortage register or contact your national competent authority.
• You may also contact relevant healthcare professional organisations for further information. A list of European not-for-profit organisations EMA engages with can be found on the EMA website.

Recommendations for patients and carers

• There is a shortage of Zypadhera in most countries of the EEA, which is expected to last until October 2025.
• If your medicine is not available, your doctor will discuss suitable alternatives with you.
• If you have any questions, speak to your doctor or pharmacist.
• For additional information, consult your country’s shortage register or contact your national competent authority.
• You may also contact relevant patients’ organisations for further information or support. A list of European not-for-profit organisations that EMA engages with can be found on the EMA website.

Key facts

• Medicines affected:
  Zypadhera
• Supply shortage status:
  Ongoing
• International non-proprietary name (INN) or common name:
  olanzapine
• Therapeutic area (MESH):
  Schizophrenia
• Pharmaceutical forms affected:
  Powder and solvent for prolonged-release suspension for injection
• Strengths affected:
  • 210 mg
  • 300 mg
  • 405 mg
• Availability of alternatives:
  Yes

Key dates

• Expected resolution:
  October 2025
• First published:
  09/07/2024
• Last updated:
  27/08/2025