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💊 Medicine EU 8 maggio 2025

Fiasp PumpCart (insulin aspart)

📷 PubChem CID 16132418 · Fonte
Fiasp PumpCart (insulin aspart)
📷 PubChem CID 16132418 · Fonte

Fiasp PumpCart (insulina aspart) Denominazione comune internazionale: insulina aspart

Forme
soluzione iniettabile in cartuccia
Concentrazione
100 unità/mL
Alternative
🗄
Archived (older alert)
Questa segnalazione è stata segnalata 385 giorni fa ed è stata spostata dal nostro feed attivo all'archivio. Le informazioni sulla sicurezza originali rimangono valide — Non abbiamo ancora conferma dall'ente emittente che il prodotto sia sicuro. Consultare l'avviso ufficiale per lo stato attuale.
📈 Cronologia
12 giorni in totale
16 maggio 2026 28 maggio 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.

🤖 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
Ultimo aggiornamento
18/12/2025
Prima pubblicazione
12/05/2025
Farmaci interessati
Fiasp PumpCart (insulin aspart)
Punti di forza interessati
100 units/mL
Stato di carenza di fornitura
Ongoing
Inizio della carenza di fornitura
08/05/2025
Disponibilità di alternative
Yes
Forme farmaceutiche interessate
Solution for injection in a cartridge
Nome internazionale non brevettato (INN) o nome comune
insulin aspart

Contenuti della pagina

Informazioni sulla carenza

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 della carenza

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.

Stati membri interessati

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.

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

Raccomandazioni per gli operatori sanitari

  • 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.

Raccomandazioni per pazienti e caregiver

  • 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. 

Fatti principali

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

Date chiave

Start of supply shortage
First published
Last updated

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

Prima pubblicazione
8 maggio 2025
Ultimo aggiornamento da noi
45 minuti fa
Gravità (classificata)
Alto
Fonte ufficiale
https://www.ema.europa.eu/en/medicines/human/shortages/fiasp-pumpcart-insulin-aspart

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

❓ Domande frequenti

Di che tipo di avviso si tratta?
Fiasp PumpCart (insulin aspart). Fiasp PumpCart (insulina aspart) Denominazione comune internazionale: insulina aspart · Forme: soluzione iniettabile in cartuccia · Concentrazione: 100 unità/mL · Alternative: sì
Quando è stata emessa questa allerta?
Questo avviso è stato emesso il 8 maggio 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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