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💊 Medicine EU 11 marzo 2025

Quetiapine

📷 Wikipedia: Quetiapine · Fonte
Quetiapine
📷 Wikipedia: Quetiapine · Fonte
Quetiapina Forme
compressa a rilascio prolungato
Forze
50 mg; 150 mg; 200 mg; 300 mg; 400 mg
Area
Schizofrenia; Disturbo bipolare; Disturbo depressivo
Alternative
⚠️
Shortage ongoing
è attualmente carente in EU.
📈 Cronologia
13 giorni attivo finora
16 maggio 2026 28 maggio 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.

🤖 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
04/05/2026
Prima pubblicazione
11/03/2025
Farmaci interessati
Quetiapine
Punti di forza interessati
50 mg150 mg200 mg300 mg400 mg
Risoluzione prevista
Within the second quarter of 2027
Stato di carenza di fornitura
Ongoing
Area terapeutica (MeSH)
SchizophreniaBipolar DisorderDepressive Disorder
Inizio della carenza di fornitura
11/03/2025
Disponibilità di alternative
Yes
Forme farmaceutiche interessate
Extended-release tablet

Contenuti della pagina

Informazioni sulla carenza

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. 

Motivo della carenza

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.

Stati membri interessati

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.

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 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.

Raccomandazioni per gli operatori sanitari

  • 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.

Raccomandazioni per pazienti e caregiver

  • 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. 

Fatti principali

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

Date chiave

Start of supply shortage
Expected resolution
Within the second quarter of 2027
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
Marca(e) / nome(i) del prodotto
Dettaglio pubblicato dall'ente

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

Prima pubblicazione
11 marzo 2025
Ultimo aggiornamento da noi
8 ore fa
Gravità (classificata)
Alto
Fonte ufficiale
https://www.ema.europa.eu/en/medicines/human/shortages/quetiapine

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?
Quetiapine. Quetiapina Forme: compressa a rilascio prolungato · Forze: 50 mg; 150 mg; 200 mg; 300 mg; 400 mg · Area: Schizofrenia; Disturbo bipolare; Disturbo depressivo · Alternative: Sì
Quando è stata emessa questa allerta?
Questo avviso è stato emesso il 11 marzo 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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