Quetiapine - supply shortage
Ongoing
ShortageHuman
Shortage information
There is a shortage of extended-release tablets of quetiapine in some EU 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, and;
- 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 last until the end of June 2025.
The shortage affects the following Member States where the product is marketed:Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Norway, Portugal, Romania, Slovenia, Slovakia, Sweden, and Spain.
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 shortage and this is expected to last until June 2025.
- 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 Member State.
- 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 shortage and this is expected to last until June 2025.
- If the brand you use is unavailable, there may be alternative extended-release quetiapine products authorised in your Member State, 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.
Key facts
- 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
- 300 mg
- 400 mg
- Availability of alternatives
- Yes
Key dates
- Start of supply shortage
- Expected resolution
- End of June 2025
- First published