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💊 Medicine EU 11 maart 2025

Quetiapine

📷 Wikipedia: Quetiapine · Bron
Quetiapine
📷 Wikipedia: Quetiapine · Bron
Quetiapine Vorm
tablet met vertraagde afgifte
Sterktes
50 mg; 150 mg; 200 mg; 300 mg; 400 mg
Toepassing
schizofrenie; bipolaire stoornis; depressieve stoornis
Alternatieven
ja
🗄
Archived (older alert)
Deze melding is 443 dagen geleden gemeld en is verplaatst van onze actieve feed naar het archief. De oorspronkelijke veiligheidsinformatie blijft van toepassing — We hebben geen bevestiging van de uitgifte-instantie dat het product veilig is. Raadpleeg de officiële mededeling voor de actuele status.
📈 Tijdlijn
12 dagen in totaal
16 mei 2026 28 mei 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.

🤖 Deze begrijpelijke samenvatting wordt automatisch gegenereerd vanuit de officiële mededeling van de instantie met behulp van AI. Het is uitsluitend bedoeld voor algemene informatie — niet als medisch advies. Raadpleeg voor beslissingen over uw gezondheid altijd een apotheker of arts en lees de officiële bron hieronder.

📋 Van de officiële mededeling van de instantie

Bijgewerkt 1 week geleden
Laatst bijgewerkt
04/05/2026
Eerst gepubliceerd
11/03/2025
Geneesmiddelen die zijn getroffen
Quetiapine
Sterktes beïnvloed
50 mg150 mg200 mg300 mg400 mg
Verwachte oplossing
Within the second quarter of 2027
Tekortstatus
Ongoing
Therapeutisch gebied (MeSH)
SchizophreniaBipolar DisorderDepressive Disorder
Begin van tekort aan voorraad
11/03/2025
Beschikbaarheid van alternatieven
Yes
Farmaceutische vormen getroffen
Extended-release tablet

Inhoud van de pagina

Tekortinformatie

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. 

Reden voor tekort

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.

Lidstaten die getroffen zijn

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.

Monitoring van tekorten

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.

Aanbevelingen voor zorgprofessionals

  • 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.

Aanbevelingen voor patiënten en mantelzorgers

  • 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. 

Belangrijkste feiten

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

Belangrijke data

Start of supply shortage
Expected resolution
Within the second quarter of 2027
First published
Last updated

Medische informatie

De inhoud hierboven is overgenomen van de officiële pagina van de instantie (link hieronder). We bewerken, interpreteren of voegen er niets aan toe.
🔬 Medische / technische details voor professionals
Merk(en) / productnaam(s)
Agentschap-publicatie-detail

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

Eerst gepubliceerd
11 maart 2025
Voor het laatst ververst door ons
1 uur geleden
Ernst (zoals geclassificeerd)
Hoog
Officiële bron
https://www.ema.europa.eu/en/medicines/human/shortages/quetiapine

Alle informatie op deze pagina komt van de officiële mededeling van de instantie. Wij vertalen en vatten deze samen; wij voegen geen feiten toe of wijzigen deze.

❓ Veelgestelde vragen

Waar gaat deze medicine shortage-melding over?
Quetiapine. Quetiapine Vorm: tablet met vertraagde afgifte · Sterktes: 50 mg; 150 mg; 200 mg; 300 mg; 400 mg · Toepassing: schizofrenie; bipolaire stoornis; depressieve stoornis · Alternatieven: ja
Wanneer is deze melding uitgegeven?
Deze melding is uitgegeven op 11 maart 2025 door EMA (European Medicines Agency).
Welke landen zijn getroffen?
De melding is van toepassing op de gehele EU.
Hoe ernstig is deze melding?
:ernst. :uitleg
Wat moet ik doen?
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.
Waar kan ik de officiële mededeling vinden?
De volledige officiële mededeling is gepubliceerd op www.ema.europa.eu.

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