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💊 Medicine EU 8. maj 2025

Fiasp PumpCart (insulin aspart)

Fiasp PumpCart (insulin aspart)

Fiasp PumpCart (insulin aspart) INN: insulin aspart

Former
Injektionsvæske i patron
Styrke
100 enheder/mL
Alternativer
Ja
🗄
Archived (older alert)
Denne advarsel blev rapporteret for 385 dage siden og er blevet flyttet fra vores aktive feed til arkivet. Den oprindelige sikkerhedsinformation gælder stadig — Vi har endnu ikke modtaget bekræftelse fra udstedelsesmyndigheden om, at produktet er sikkert igen. Se den officielle meddelelse for den aktuelle status.
📈 Tidslinje
12 dage i alt
16. maj 2026 28. maj 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.

🤖 Denne letforståelige oversigt er automatisk genereret ud fra den officielle meddelelse fra myndigheden ved hjælp af AI. Den er udelukkende til generel information — ikke medicinsk rådgivning. Vedrørende beslutninger om din sundhed, skal du altid konsultere en farmaceut eller læge og læse den officielle kilde, der er linket nedenfor.

📋 Fra den officielle meddelelse fra myndigheden

Opdateret for 1 uge siden
Senest opdateret
18/12/2025
Først udgivet
12/05/2025
Berørte lægemidler
Fiasp PumpCart (insulin aspart)
Berørte styrker
100 units/mL
Lagerstatus
Ongoing
Start på forsyningsmangel
08/05/2025
Tilgængelighed af alternativer
Yes
Berørte lægemiddelformer
Solution for injection in a cartridge
Internationalt ikke-ejendomsretligt navn (INN) eller fællesnavn
insulin aspart

Sideindhold

Mangel på lager

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. 

Årsag til mangel

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.

Berørte medlemsstater

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.

Overvågning af mangel

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.

Anbefalinger til sundhedspersonale

  • 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.

Anbefalinger til patienter og pårørende

  • 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. 

Nøgleoplysninger

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

Nøgledatoer

Start of supply shortage
First published
Last updated

Relateret medicinsk information

Indholdet ovenfor er gengivet fra den officielle myndighedsside (link nedenfor). Vi redigerer, fortolker eller tilføjer ikke til det.
🔬 Medicinske/tekniske detaljer Til fagfolk
Aktivt stof(fer)
Mærke(r) / produktnavn(e)
Agenturpubliceret detalje

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

Først udgivet
8. maj 2025
Sidst opdateret af os
for 46 minutter siden
Alvorlighed (klassificeret)
Høj
Officiel kilde
https://www.ema.europa.eu/en/medicines/human/shortages/fiasp-pumpcart-insulin-aspart

Alle oplysninger på denne side stammer fra den officielle meddelelse fra myndighederne. Vi oversætter og opsummerer den; vi tilføjer eller redigerer ikke fakta.

❓ Ofte stillede spørgsmål

Hvad drejer denne medicine shortage-alarm sig om?
Fiasp PumpCart (insulin aspart). Fiasp PumpCart (insulin aspart) INN: insulin aspart · Former: Injektionsvæske i patron · Styrke: 100 enheder/mL · Alternativer: Ja
Hvornår blev denne advarsel udstedt?
Denne meddelelse blev udsendt den 8. maj 2025 af EMA (European Medicines Agency).
Hvilke lande er berørt?
Alerten gælder for hele EU.
Hvor alvorlig er denne advarsel?
:alvorlighed. :forklaring
Hvad skal jeg gøre?
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.
Hvor kan jeg finde den officielle meddelelse?
Den fulde officielle meddelelse er offentliggjort på www.ema.europa.eu.

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