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💊 Medicine EU 11. marts 2025

Quetiapine

Quetiapine
Quetiapin Former: Depot-tablet Styrker: 50 mg; 150 mg; 200 mg; 300 mg; 400 mg Anvendelse: Skizofreni; bipolar lidelse; depressiv lidelse Andre muligheder: Ja
⚠️
Shortage ongoing
er i øjeblikket i begrænset udbud i EU.
📈 Tidslinje
13 dage aktiv indtil videre
16. maj 2026 28. maj 2026

What is this? Quetiapine is a medicine used to treat mental health problems like schizophrenia and bipolar disorder.

What's happening? There is a shortage of quetiapine tablets in some EU countries.

Does this affect me? If you take quetiapine, you may be affected.

What should I do? Talk to your pharmacist or doctor before making any changes.

🤖 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
04/05/2026
Først udgivet
11/03/2025
Berørte lægemidler
Quetiapine
Berørte styrker
50 mg150 mg200 mg300 mg400 mg
Forventet opløsning
Within the second quarter of 2027
Lagerstatus
Ongoing
Terapirigt område (MESH)
SchizophreniaBipolar DisorderDepressive Disorder
Start på forsyningsmangel
11/03/2025
Tilgængelighed af alternativer
Yes
Berørte lægemiddelformer
Extended-release tablet

Sideindhold

Mangel på lager

There is a shortage of extended-release tablets of quetiapine in some EU/EEA (European Union/European Economic Area) Member States.

Quetiapine-containing medicines are used to treat psychiatric disorders including:

  • schizophrenia, a mental illness with symptoms such as disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs);
  • bipolar disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood, as well as episodes of depression;
  • certain types of depression.

Quetiapine-containing medicines are available as tablets that are taken by mouth, in either an immediate-release or extended-release formulation. Extended release means that the active substance in the medicine is released slowly over time.

Several Member States are experiencing an increase in demand for medicines containing extended-release quetiapine. In addition, the manufacturer that supplies this formulation to several companies in the EU has faced a production issue. These events combined have led to a shortage of this medicine in the EU/EEA.

The shortage is expected to continue through the second quarter of 2027.

The shortage affects the following countries where the product is marketed:Austria, Belgium, Bulgaria, Croatia, Czechia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.

This information may change. 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 are engaging with impacted marketing authorisation holders, as well as alternative marketing authorisation holders to mitigate the impact of the supply shortage. This includes assistance from EMA’s solidarity mechanism whereby affected Member States can request help from other Member States in obtaining medicine stocks.

  • Extended-release tablets of quetiapine are in short supply; this is expected to continue through the second quarter of 2027.
  • Before initiating treatment with extended-release tablets of quetiapine, you should check with your national competent authority in case they have issued national recommendations.
  • If the brand that you prescribe or dispense is not available, other extended-release quetiapine products may be available. If not, you should consider switching patients to an alternative treatment. Immediate-release quetiapine products may also be available, depending on the country.
  • For additional information consult your country’s shortage register or contact your national competent authority. Your national competent authority may have issued further national recommendations.

  • Extended-release tablets of quetiapine are in short supply; this is expected to continue through the second quarter of 2027.
  • If the brand you use is unavailable, there may be alternative extended-release quetiapine products authorised in your country, immediate-release quetiapine products or other treatment alternatives. Your doctor will discuss suitable options 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. 

Årsag til mangel

Several Member States are experiencing an increase in demand for medicines containing extended-release quetiapine. In addition, the manufacturer that supplies this formulation to several companies in the EU has faced a production issue. These events combined have led to a shortage of this medicine in the EU/EEA.

The shortage is expected to continue through the second quarter of 2027.

Berørte medlemsstater

The shortage affects the following countries where the product is marketed:Austria, Belgium, Bulgaria, Croatia, Czechia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.

This information may change. 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 are engaging with impacted marketing authorisation holders, as well as alternative marketing authorisation holders to mitigate the impact of the supply shortage. This includes assistance from EMA’s solidarity mechanism whereby affected Member States can request help from other Member States in obtaining medicine stocks.

Anbefalinger til sundhedspersonale

  • Extended-release tablets of quetiapine are in short supply; this is expected to continue through the second quarter of 2027.
  • Before initiating treatment with extended-release tablets of quetiapine, you should check with your national competent authority in case they have issued national recommendations.
  • If the brand that you prescribe or dispense is not available, other extended-release quetiapine products may be available. If not, you should consider switching patients to an alternative treatment. Immediate-release quetiapine products may also be available, depending on the country.
  • For additional information consult your country’s shortage register or contact your national competent authority. Your national competent authority may have issued further national recommendations.

Anbefalinger til patienter og pårørende

  • Extended-release tablets of quetiapine are in short supply; this is expected to continue through the second quarter of 2027.
  • If the brand you use is unavailable, there may be alternative extended-release quetiapine products authorised in your country, immediate-release quetiapine products or other treatment alternatives. Your doctor will discuss suitable options 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. 

Nøgleoplysninger

Medicines affected
Quetiapine
Supply shortage status
Ongoing
Therapeutic area (MESH)
  • Schizophrenia
  • Bipolar Disorder
  • Depressive Disorder
Pharmaceutical forms affected
Extended-release tablet
Strengths affected
  • 50 mg
  • 150 mg
  • 200 mg
  • 300 mg
  • 400 mg
Availability of alternatives
Yes

Nøgledatoer

Start of supply shortage
Expected resolution
Within the second quarter of 2027
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
Mærke(r) / produktnavn(e)
Agenturpubliceret detalje

Forms: Extended-release tablet · Strengths: 50 mg;150 mg;200 mg;300 mg;400 mg · Area: Schizophrenia;Bipolar Disorder;Depressive Disorder · Alternatives: Yes

Først udgivet
11. marts 2025
Sidst opdateret af os
for 8 timer siden
Alvorlighed (klassificeret)
Høj
Officiel kilde
https://www.ema.europa.eu/en/medicines/human/shortages/quetiapine

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?
Quetiapine. Quetiapin Former: Depot-tablet Styrker: 50 mg; 150 mg; 200 mg; 300 mg; 400 mg Anvendelse: Skizofreni; bipolar lidelse; depressiv lidelse Andre muligheder: Ja
Hvornår blev denne advarsel udstedt?
Denne meddelelse blev udsendt den 11. marts 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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