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💊 Medicine EU 19 de novembro de 2025

Risperidone

Risperidona DCB
risperidona
Formas
suspensão de liberação prolongada para injeção
Área
esquizofrenia
Alternativas
sim
⚠️
Shortage ongoing
risperidone está em falta em EU.
📈 Linha do tempo
12 dias ativos até agora
16 de maio de 2026 27 de maio de 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.

🤖 Este resumo em linguagem simples é gerado automaticamente a partir do comunicado oficial da agência, com recurso a IA. Destina-se apenas a fins informativos — não constitui aconselhamento médico. Para tomar decisões sobre a sua saúde, consulte sempre um farmacêutico ou médico e leia a fonte oficial vinculada abaixo.

📋 Da notificação oficial da agência

Atualizado há 1 semana
Primeira publicação
19/11/2025
Medicamentos afetados
Risperidone
Resolução esperada
Risperdal Consta - by the end of 2025 Risperidone Teva and Sperizak - to continue until the end of 2026 or beginning of 2027
Status de escassez de suprimentos
Ongoing
Área terapêutica (MeSH)
Schizophrenia
Disponibilidade de alternativas
Yes
Formas farmacêuticas afetadas
Prolonged-release suspension for injection
Nome internacional não proprietário (INN) ou nome comum
risperidone

Conteúdo da página

Informações sobre escassez

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 da escassez

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.

Estados-Membros afetados

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.

Monitorização de escassez

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.

Recomendações para profissionais de saúde

  • 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.

Recomendações para doentes e cuidadores

  • 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.

Principais informações

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

Datas importantes

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

Informações relacionadas sobre saúde

O conteúdo acima é reproduzido da página oficial da agência (link abaixo). Não o editamos, interpretamos ou acrescentamos informações.
🔬 Detalhes médicos/técnicos (para profissionais)
Substância(s) ativa(s)
Marca(s) / nome(s) do(s) produto(s)
Detalhe publicado pela agência

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

Primeira publicação
19 de novembro de 2025
Atualizado por nós
há 14 horas
Gravidade (classificada)
Alto
Fonte oficial
https://www.ema.europa.eu/en/medicines/human/shortages/risperidone

Todas as informações desta página são provenientes do comunicado oficial da agência. Nós as traduzimos e resumimos; não adicionamos nem editamos factos.

Alertas relacionados

❓ Perguntas frequentes

Sobre que alerta de medicine shortage se trata?
Risperidone. Risperidona DCB: risperidona · Formas: suspensão de liberação prolongada para injeção · Área: esquizofrenia · Alternativas: sim
Quando foi emitido este alerta?
Este alerta foi emitido em 19 de novembro de 2025 por EMA (European Medicines Agency).
Quais países são afetados?
O alerta aplica-se a a totalidade da UE
Qual a gravidade deste alerta?
:severidade. A serious risk means the product or medicine can cause significant harm. Treat the alert as urgent.
O que devo fazer?
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.
Onde posso encontrar o aviso oficial?
A íntegra do aviso oficial está publicada em www.ema.europa.eu.

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