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💊 Medicine EU 19 novembre 2025

Risperidone

📷 Wikipedia: Risperidone · Source
Risperidone
📷 Wikipedia: Risperidone · Source
Rispéridone DCI
rispéridone
Formes
suspension à libération prolongée pour injection
Domaine
schizophrénie
Alternatives
oui
⚠️
Shortage ongoing
risperidone est actuellement en pénurie dans EU.
📈 Chronologie
12 jours actif jusqu'à présent
16 mai 2026 27 mai 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.

🤖 Ce résumé en langage clair est généré automatiquement à partir de l'avis officiel de l'agence à l'aide de l'IA. Il est fourni à titre d'information générale uniquement — il ne s'agit pas de conseils médicaux. Pour toute décision concernant votre santé, consultez toujours un pharmacien ou un médecin et lisez la source officielle liée ci-dessous.

📋 De l'avis officiel de l'agence

Mis à jour il y a 1 semaine
Première publication
19/11/2025
Médicaments concernés
Risperidone
Résolution attendue
Risperdal Consta - by the end of 2025 Risperidone Teva and Sperizak - to continue until the end of 2026 or beginning of 2027
Statut de pénurie
Ongoing
Zone thérapeutique (MeSH)
Schizophrenia
Disponibilité des alternatives
Yes
Formes pharmaceutiques concernées
Prolonged-release suspension for injection
Dénomination commune internationale (DCI) ou nom commun
risperidone

Contenu de la page

Information sur la pénurie

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.

Raison de la pénurie

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.

États membres concernés

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.

Surveillance des pénuries

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.

Recommandations pour les professionnels de santé

  • 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.

Recommandations pour les patients et les aidants

  • 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.

Points clés

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

Dates clés

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

Informations médicales connexes

Le contenu ci-dessus est reproduit à partir de la page officielle de l'agence (lien ci-dessous). Nous ne le modifions pas, ne l'interprétons pas et n'y ajoutons rien.
🔬 Détails médicaux / techniques (pour les professionnels)
Substance(s) active(s)
Marque(s) / nom(s) de produit
Détail publié par l'agence

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

Première publication
19 novembre 2025
Dernière actualisation par nos soins
il y a 14 heures
Gravité (classée)
Élevé
Source officielle
https://www.ema.europa.eu/en/medicines/human/shortages/risperidone

Toutes les informations de cette page proviennent de l'avis officiel de l'agence. Nous les traduisons et les résumons ; nous n'ajoutons ni ne modifions les faits.

Alertes associées

❓ Questions fréquentes

De quel type d'alerte s'agit-il ?
Risperidone. Rispéridone DCI : rispéridone · Formes : suspension à libération prolongée pour injection · Domaine : schizophrénie · Alternatives : oui
Quand cet avertissement a-t-il été émis ?
Cette alerte a été émise le 19 novembre 2025 par EMA (European Medicines Agency).
Quels pays sont concernés ?
L'alerte s'applique à l'ensemble de l'UE.
À quel point cette alerte est-elle sérieuse ?
:sévérité. A serious risk means the product or medicine can cause significant harm. Treat the alert as urgent.
Que faire ?
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.
Où puis-je trouver l'avis officiel ?
L'avis officiel complet est publié sur www.ema.europa.eu.

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