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💊 Medicine EU 8 de mayo de 2025

Fiasp PumpCart (insulin aspart)

Fiasp PumpCart (insulin aspart)

Fiasp PumpCart (insulina aspart) DCI: insulina aspart

Formas
solución inyectable en cartucho
Concentración
100 unidades/mL
Alternativas
⚠️
Shortage ongoing
insulin aspart actualmente está en escasez en EU.
📈 Línea de tiempo
12 días activo hasta ahora
16 de mayo de 2026 27 de mayo 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 resumen en lenguaje sencillo se genera automáticamente a partir del aviso oficial de la agencia mediante IA. Es solo para fines informativos — no es un consejo médico. Para tomar decisiones sobre su salud, consulte siempre a un farmacéutico o médico y lea la fuente oficial vinculada a continuación.

📋 De la notificación oficial de la agencia

Actualizado hace 1 semana
Última actualización
18/12/2025
Primera publicación
12/05/2025
Medicamentos afectados
Fiasp PumpCart (insulin aspart)
Aptitudes afectadas
100 units/mL
Estado de escasez de suministro
Ongoing
Inicio de escasez de suministro
08/05/2025
Disponibilidad de alternativas
Yes
Formas farmacéuticas afectadas
Solution for injection in a cartridge
Nombre internacional no propitario (INN) o nombre común
insulin aspart

Contenido de la página

Información de escasez

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 de escasez

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 miembros afectados

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.

Seguimiento de escasez

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.

Recomendaciones para profesionales de la salud

  • 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.

Recomendaciones para pacientes y 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. 

Datos clave

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

Fechas clave

Start of supply shortage
First published
Last updated

Información relacionada sobre salud

El contenido anterior se reproduce de la página oficial de la agencia (enlace a continuación). No lo editamos, interpretamos ni añadimos información.
🔬 Detalles médicos/técnicos Para profesionales
Sustancia(s) activa(s)
Marca(s) / nombre(s) de producto
Detalle publicado por la agencia

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

Primera publicación
8 de mayo de 2025
Última actualización por nosotros
hace 15 horas
Gravedad (según clasificación)
Alto
Fuente oficial
https://www.ema.europa.eu/en/medicines/human/shortages/fiasp-pumpcart-insulin-aspart

Toda la información de esta página proviene del aviso oficial de la agencia. Nosotros la traducimos y resumimos; no añadimos ni editamos datos.

❓ Preguntas frecuentes

¿De qué se trata esta alerta de medicine shortage?
Fiasp PumpCart (insulin aspart). Fiasp PumpCart (insulina aspart) DCI: insulina aspart · Formas: solución inyectable en cartucho · Concentración: 100 unidades/mL · Alternativas: sí
¿Cuándo se emitió esta alerta?
Esta alerta se emitió el 8 de mayo de 2025 por EMA (European Medicines Agency).
¿Qué países se ven afectados?
La alerta aplica a el conjunto de la UE.
¿Qué tan grave es esta alerta?
:severidad. A serious risk means the product or medicine can cause significant harm. Treat the alert as urgent.
¿Qué debo hacer?
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.
¿Dónde puedo encontrar el aviso oficial?
La notificación oficial completa se publica en www.ema.europa.eu.

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