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💊 Medicine EU 19 novembre 2025

Risperidone

📷 Wikipedia: Risperidone · Fonte
Risperidone
📷 Wikipedia: Risperidone · Fonte
Risperidone INN
risperidone
Forme
sospensione a rilascio prolungato per iniezione
Area
schizofrenia
⚠️
Shortage ongoing
risperidone è attualmente carente in EU.
📈 Cronologia
12 giorni attivo finora
16 maggio 2026 27 maggio 2026

What is this? Risperidone is a medicine used to treat schizophrenia. It comes as a shot that lasts for weeks.

What's happening? There is not enough of this shot right now in the EU. Other forms of risperidone are still available.

Does this affect me? If you take this shot for schizophrenia, you may be affected. Check with your doctor.

What should I do? Talk to your pharmacist or doctor before making any changes to your medicine.

🤖 Questo riassunto in linguaggio semplice viene generato automaticamente dalla notifica ufficiale dell'agenzia tramite IA. È solo a scopo informativo generale — non è un consiglio medico. Per decisioni relative alla tua salute, consulta sempre un farmacista o un medico e leggi la fonte ufficiale collegata di seguito.

📋 Dalla comunicazione ufficiale dell'ente

Aggiornato 1 settimana fa
Prima pubblicazione
19/11/2025
Farmaci interessati
Risperidone
Risoluzione prevista
Risperdal Consta - by the end of 2025 Risperidone Teva and Sperizak - to continue until the end of 2026 or beginning of 2027
Stato di carenza di fornitura
Ongoing
Area terapeutica (MeSH)
Schizophrenia
Disponibilità di alternative
Yes
Forme farmaceutiche interessate
Prolonged-release suspension for injection
Nome internazionale non brevettato (INN) o nome comune
risperidone

Contenuti della pagina

Informazioni sulla carenza

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.

Motivo della carenza

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.

Stati membri interessati

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.

Monitoraggio della carenza

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.

Raccomandazioni per gli operatori sanitari

  • 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.

Raccomandazioni per pazienti e caregiver

  • 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.

Fatti principali

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

Date chiave

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

Informazioni correlate sulla salute

Il contenuto sopra è riprodotto dalla pagina ufficiale dell'ente (link sotto). Non lo modifichiamo, interpretiamo o aggiungiamo informazioni.
🔬 Dettagli medici/tecnici Per professionisti
Sostanza(e) attiva(e)
Marca(e) / nome(i) del prodotto
Dettaglio pubblicato dall'ente

INN: risperidone · Forms: Prolonged-release suspension for injection · Area: Schizophrenia · Alternatives: Yes

Prima pubblicazione
19 novembre 2025
Ultimo aggiornamento da noi
16 ore fa
Gravità (classificata)
Alto
Fonte ufficiale
https://www.ema.europa.eu/en/medicines/human/shortages/risperidone

Tutte le informazioni su questa pagina provengono dal comunicato ufficiale dell'agenzia. Le traduciamo e le riassumiamo; non aggiungiamo né modifichiamo i fatti.

Avvisi correlati

❓ Domande frequenti

Di che tipo di avviso si tratta?
Risperidone. Risperidone INN: risperidone · Forme: sospensione a rilascio prolungato per iniezione · Area: schizofrenia
Quando è stata emessa questa allerta?
Questo avviso è stato emesso il 19 novembre 2025 da EMA (European Medicines Agency).
Quali paesi sono interessati?
L'avviso si applica a l'intera UE.
Quanto è grave questo avviso?
:severità. A serious risk means the product or medicine can cause significant harm. Treat the alert as urgent.
Cosa devo fare?
If you take this medicine, contact your pharmacist or prescribing doctor. They can advise on alternative products or substitutes. Do not stop taking prescription medicine without medical advice.
Dove posso trovare l'avviso ufficiale?
L'avviso ufficiale completo è pubblicato su www.ema.europa.eu.

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