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💊 Medicine EU 19. listopadu 2025

Risperidone

Risperidon Mezinárodní nechráněný název
risperidon
Formy
Prodloužená suspenze pro injekci
Oblast použití
Schizofrenie
Alternativy
Ano
⚠️
Shortage ongoing
risperidone je v současnosti nedostatek v EU.
📈 Časová osa
12 dny aktivní doposud
16. května 2026 27. května 2026

What is this? Risperidone is a medicine used to treat schizophrenia. It comes as a shot that lasts for weeks.

What's happening? There is not enough of this shot right now in the EU. Other forms of risperidone are still available.

Does this affect me? If you take this shot for schizophrenia, you may be affected. Check with your doctor.

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

🤖 Tento souhrn v jednoduchém jazyce byl automaticky vytvořen z oficiálního oznámení agentury pomocí AI. Slouží pouze pro obecné informace — nikoli jako lékařská rada. Při rozhodování o svém zdraví se vždy poraďte s lékárníkem či lékařem a přečtěte si oficiální zdroj uvedený níže.

📋 Z oficiálního oznámení orgánu

Aktualizováno před 1 týdnem
První publikováno
19/11/2025
Zasažené léky
Risperidone
Očekávané řešení
Risperdal Consta - by the end of 2025 Risperidone Teva and Sperizak - to continue until the end of 2026 or beginning of 2027
Stav nedostatku
Ongoing
Terapeutická oblast (MeSH)
Schizophrenia
Dostupnost alternativ
Yes
Léčivé formy postižené
Prolonged-release suspension for injection
Mezinárodní nechráněný název (INN) nebo obecný název
risperidone

Obsah stránky

Nedostatek informací

There are shortages of several risperidone prolonged-release suspension for injection products (Risperidone Teva, Risperdal Consta and Sperizak) in several EU Member States.

These medicines are used to treat schizophrenia in adults and are given as an injection into the muscle.

The companies producing Risperidone Teva, Risperdal Consta and Sperizak are experiencing manufacturing problems, which have led to shortages of these medicines.

The shortage of Risperdal Consta is expected to be resolved by the end of 2025. Those of Risperidone Teva and Sperizak are expected to continue until the end of 2026 or beginning of 2027.

The shortages are not related to a quality defect of the product or a safety issue.

The shortages affect several Member States where the products are marketed.

As the shortage situation is changing quickly, 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 impacted marketing authorisation holders and alternative marketing authorisation holders to reduce the impact of the supply shortage and ensure a fair distribution of stock among the Member States.

The SPOC Working Party Supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.

  • There is a shortage of Risperidone Teva, Risperdal Consta and Sperizak prolonged-release suspension for injection in several EU Member States.
  • The shortage of Risperdal Consta is expected to be resolved by the end of 2025. Those of Risperidone Teva and Sperizak are expected to continue until the end of 2026 or beginning of 2027.
  • Before initiating treatment with these medicines, you should check with your national competent authority in case they have issued national recommendations.
  • There may be alternative prolonged-release risperidone medicines authorised in your country which can be used instead. If there is no alternative prolonged-release risperidone medicine, you should consider switching patients to an alternative treatment.
  • For additional information, consult your country’s shortage register or contact your national competent authority.
  • You may also contact relevant healthcare professional organisations for further information. A list of European not-for-profit organisations EMA engages with can be found on the EMA website.

  • There is a shortage of Risperidone Teva, Risperdal Consta and Sperizak prolonged-release suspension for injection in several EU Member States.
  • The shortage of Risperdal Consta is expected to be resolved by the end of 2025. Those of Risperidone Teva and Sperizak are expected to continue until the end of 2026 or beginning of 2027.
  • There may be alternative prolonged-release risperidone medicines authorised in your country which can be used instead. If there is no alternative prolonged-release risperidone medicine, your doctor will discuss treatment alternatives 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.

Důvod nedostatku

The companies producing Risperidone Teva, Risperdal Consta and Sperizak are experiencing manufacturing problems, which have led to shortages of these medicines.

The shortage of Risperdal Consta is expected to be resolved by the end of 2025. Those of Risperidone Teva and Sperizak are expected to continue until the end of 2026 or beginning of 2027.

The shortages are not related to a quality defect of the product or a safety issue.

Dotčené členské státy

The shortages affect several Member States where the products are marketed.

As the shortage situation is changing quickly, 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.

Sledování nedostatku

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 impacted marketing authorisation holders and alternative marketing authorisation holders to reduce the impact of the supply shortage and ensure a fair distribution of stock among the Member States.

The SPOC Working Party Supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.

Doporučení pro zdravotnické pracovníky

  • There is a shortage of Risperidone Teva, Risperdal Consta and Sperizak prolonged-release suspension for injection in several EU Member States.
  • The shortage of Risperdal Consta is expected to be resolved by the end of 2025. Those of Risperidone Teva and Sperizak are expected to continue until the end of 2026 or beginning of 2027.
  • Before initiating treatment with these medicines, you should check with your national competent authority in case they have issued national recommendations.
  • There may be alternative prolonged-release risperidone medicines authorised in your country which can be used instead. If there is no alternative prolonged-release risperidone medicine, you should consider switching patients to an alternative treatment.
  • For additional information, consult your country’s shortage register or contact your national competent authority.
  • You may also contact relevant healthcare professional organisations for further information. A list of European not-for-profit organisations EMA engages with can be found on the EMA website.

Doporučení pro pacienty a pečující

  • There is a shortage of Risperidone Teva, Risperdal Consta and Sperizak prolonged-release suspension for injection in several EU Member States.
  • The shortage of Risperdal Consta is expected to be resolved by the end of 2025. Those of Risperidone Teva and Sperizak are expected to continue until the end of 2026 or beginning of 2027.
  • There may be alternative prolonged-release risperidone medicines authorised in your country which can be used instead. If there is no alternative prolonged-release risperidone medicine, your doctor will discuss treatment alternatives 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.

Klíčové údaje

Medicines affected
Risperidone
Supply shortage status
Ongoing
International non-proprietary name (INN) or common name
risperidone
Therapeutic area (MESH)
Schizophrenia
Pharmaceutical forms affected
Prolonged-release suspension for injection
Availability of alternatives
Yes

Klíčová data

Expected resolution
Risperdal Consta - by the end of 2025
Risperidone Teva and Sperizak - to continue until the end of 2026 or beginning of 2027
First published

Související zdravotnické informace

Obsah výše je převzat z oficiální stránky příslušného orgánu (odkaz níže). Neupravujeme, neinterpretujeme ani nepřidáváme žádné informace.
🔬 Lékařské / technické podrobnosti (pro profesionály)
Účinná látka(y)
Značky / názvy výrobků
Agenturně zveřejněný detail

INN: risperidone · Forms: Prolonged-release suspension for injection · Area: Schizophrenia · Alternatives: Yes

První publikováno
19. listopadu 2025
Posledně aktualizováno námi
před 16 hodinami
Závažnost (dle klasifikace)
Vysoký
Oficiální zdroj
https://www.ema.europa.eu/en/medicines/human/shortages/risperidone

Veškeré informace na této stránce pocházejí z oficiálního oznámení příslušného orgánu. Překládáme a shrnujeme je; nepřidáváme ani neměníme fakta.

Související upozornění

❓ Často kladené dotazy

O čem je tato upozornění medicine shortage?
Risperidone. Risperidon Mezinárodní nechráněný název: risperidon · Formy: Prodloužená suspenze pro injekci · Oblast použití: Schizofrenie · Alternativy: Ano
Kdy byla tato výstraha vydána?
Toto upozornění bylo vydáno dne 19. listopadu 2025 zdrojem EMA (European Medicines Agency).
Které země jsou postiženy?
Upozornění se vztahuje k celé EU.
Jak závažné je toto upozornění?
:závažnost. :vysvětlení
Co mám udělat?
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.
Kde najdu oficiální oznámení?
Úplné oficiální oznámení je zveřejněno na www.ema.europa.eu.

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