Risperidone - supply shortage
Ongoing
risperidone
ShortageHuman
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Shortage information
There are shortages of several risperidone prolonged-release suspension for injection products (Risperidone Teva, Risperdal Consta and Sperizak) in several EU Member States.
These medicines are used to treat schizophrenia in adults and are given as an injection into the muscle.
The companies producing Risperidone Teva, Risperdal Consta and Sperizak are experiencing manufacturing problems, which have led to shortages of these medicines.
The shortage of Risperdal Consta is expected to be resolved by the end of 2025. Those of Risperidone Teva and Sperizak are expected to continue until the end of 2026 or beginning of 2027.
The shortages are not related to a quality defect of the product or a safety issue.
The shortages affect several Member States where the products are marketed.
As the shortage situation is changing quickly, 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.
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 impacted marketing authorisation holders and alternative marketing authorisation holders to reduce the impact of the supply shortage and ensure a fair distribution of stock among the Member States.
The SPOC Working Party Supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.
- There is a shortage of Risperidone Teva, Risperdal Consta and Sperizak prolonged-release suspension for injection in several EU Member States.
- The shortage of Risperdal Consta is expected to be resolved by the end of 2025. Those of Risperidone Teva and Sperizak are expected to continue until the end of 2026 or beginning of 2027.
- Before initiating treatment with these medicines, you should check with your national competent authority in case they have issued national recommendations.
- There may be alternative prolonged-release risperidone medicines authorised in your country which can be used instead. If there is no alternative prolonged-release risperidone medicine, you should consider switching patients to an alternative treatment.
- 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.
- There is a shortage of Risperidone Teva, Risperdal Consta and Sperizak prolonged-release suspension for injection in several EU Member States.
- The shortage of Risperdal Consta is expected to be resolved by the end of 2025. Those of Risperidone Teva and Sperizak are expected to continue until the end of 2026 or beginning of 2027.
- There may be alternative prolonged-release risperidone medicines authorised in your country which can be used instead. If there is no alternative prolonged-release risperidone medicine, your doctor will discuss treatment alternatives with you.
- Contact your pharmacy or doctor well before your current supply runs out.
- 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.
Key facts
- Medicines affected
- Risperidone
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- risperidone
- Therapeutic area (MESH)
- Schizophrenia
- Pharmaceutical forms affected
- Prolonged-release suspension for injection
- Availability of alternatives
- Yes
Key dates
- Expected resolution
- Risperdal Consta - by the end of 2025
Risperidone Teva and Sperizak - to continue until the end of 2026 or beginning of 2027 - First published