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💊 Medicine EU 8 de maio de 2025

Fiasp PumpCart (insulin aspart)

Fiasp PumpCart (insulina aspart) DCB: insulina aspart

Formas
solução injetável em cartucho
Concentração
100 unidades/mL
Alternativas
sim
⚠️
Shortage ongoing
insulin aspart está em falta em EU.
📈 Linha do tempo
13 dias ativos até agora
16 de maio de 2026 28 de maio de 2026

What is this? Fiasp PumpCart is a cartridge filled with insulin aspart. It is used in insulin pumps to help control blood sugar.

What's happening? There is a shortage of Fiasp PumpCart cartridges in the EU. Supplies are running low.

Does this affect me? If you use Fiasp PumpCart in an insulin pump, you may be affected by this shortage.

What should I do? Talk to your pharmacist or doctor about other insulin options that are available.

🤖 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
Última atualização
18/12/2025
Primeira publicação
12/05/2025
Medicamentos afetados
Fiasp PumpCart (insulin aspart)
Pontos afetados
100 units/mL
Status de escassez de suprimentos
Ongoing
Início da escassez de suprimentos
08/05/2025
Disponibilidade de alternativas
Yes
Formas farmacêuticas afetadas
Solution for injection in a cartridge
Nome internacional não proprietário (INN) ou nome comum
insulin aspart

Conteúdo da página

Informações sobre escassez

There is a shortage of Fiasp PumpCart in the EU (European Union) / EEA (European Economic Area).

Fiasp is a medicine that is used to treat children from one year of age and adults with diabetes. It contains the active substance insulin aspart, a fast-acting insulin. The Fiasp PumpCart is one of presentations of this medicine.

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

The current manufacturing capacity for Fiasp PumpCart cannot meet demand. This has led or may lead to intermittent shortages of Fiasp PumpCart. The shortages are not related to a quality defect of the product or a safety issue.

In addition, the company marketing Fiasp will discontinue Fiasp PumpCart for commercial reasons by the end of 2026 at the latest in all EU/EEA countries where the product is currently marketed.

All Member States where the product is marketed are currently affected or are at risk of being affected by the intermittent shortages: Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Netherlands, Norway, Spain and Sweden.

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 marketing authorisation holder and other stakeholders to mitigate the impact of the supply shortage and prepare for the discontinuation in 2026.

  • No new patients should be started on Fiasp PumpCart.
  • In case Fiasp PumpCart is unavailable, healthcare professionals should switch existing patients to alternative fast-acting insulin treatment based on existing guidance and clinical judgment. Other fast-acting insulins include:
    • Fiasp, NovoRapid or insulin aspart biosimilars;
    • insulin lispro or its biosimilars;
    • Insulin glulisine or its biosimilars;
  • A medicine shortage communication (MSC) has been sent to healthcare professionals in affected Member States and is also available on the EMA website.
  • For additional information, consult your country’s shortage register or contact your national competent authority.

  • Contact your healthcare professional well before your current supply runs out.
  • If you use Fiasp PumpCart regularly, your healthcare professional will discuss an alternative insulin medicine with you.
  • Your healthcare professional will ensure that you receive guidance on any changes and provided with adequate training.
  • 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 current manufacturing capacity for Fiasp PumpCart cannot meet demand. This has led or may lead to intermittent shortages of Fiasp PumpCart. The shortages are not related to a quality defect of the product or a safety issue.

In addition, the company marketing Fiasp will discontinue Fiasp PumpCart for commercial reasons by the end of 2026 at the latest in all EU/EEA countries where the product is currently marketed.

Estados-Membros afetados

All Member States where the product is marketed are currently affected or are at risk of being affected by the intermittent shortages: Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Netherlands, Norway, Spain and Sweden.

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 marketing authorisation holder and other stakeholders to mitigate the impact of the supply shortage and prepare for the discontinuation in 2026.

Recomendações para profissionais de saúde

  • No new patients should be started on Fiasp PumpCart.
  • In case Fiasp PumpCart is unavailable, healthcare professionals should switch existing patients to alternative fast-acting insulin treatment based on existing guidance and clinical judgment. Other fast-acting insulins include:
    • Fiasp, NovoRapid or insulin aspart biosimilars;
    • insulin lispro or its biosimilars;
    • Insulin glulisine or its biosimilars;
  • A medicine shortage communication (MSC) has been sent to healthcare professionals in affected Member States and is also available on the EMA website.
  • For additional information, consult your country’s shortage register or contact your national competent authority.

Recomendações para doentes e cuidadores

  • Contact your healthcare professional well before your current supply runs out.
  • If you use Fiasp PumpCart regularly, your healthcare professional will discuss an alternative insulin medicine with you.
  • Your healthcare professional will ensure that you receive guidance on any changes and provided with adequate training.
  • 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
Fiasp PumpCart (insulin aspart)
Supply shortage status
Ongoing
International non-proprietary name (INN) or common name
insulin aspart
Pharmaceutical forms affected
Solution for injection in a cartridge
Strengths affected
100 units/mL
Availability of alternatives
Yes

Datas importantes

Start of supply shortage
First published
Last updated

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: insulin aspart · Forms: Solution for injection in a cartridge · Strengths: 100 units/mL · Alternatives: Yes

Primeira publicação
8 de maio de 2025
Atualizado por nós
há 1 hora
Gravidade (classificada)
Alto
Fonte oficial
https://www.ema.europa.eu/en/medicines/human/shortages/fiasp-pumpcart-insulin-aspart

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

❓ Perguntas frequentes

Sobre que alerta de medicine shortage se trata?
Fiasp PumpCart (insulin aspart). Fiasp PumpCart (insulina aspart) DCB: insulina aspart · Formas: solução injetável em cartucho · Concentração: 100 unidades/mL · Alternativas: sim
Quando foi emitido este alerta?
Este alerta foi emitido em 8 de maio 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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