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Irish Medicines Database · HPRA register

RISPERDAL CONSTA 25 mg powder and solvent for prolonged-release suspension for injection

Authorisation PA22612/010/010 · Janssen Sciences Ireland Unlimited Company

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RISPERDAL CONSTA 25 mg powder and solvent for prolonged-release suspension for injection

Licence PA22612/010/010 · Marketed

Licence holder: Janssen Sciences Ireland Unlimited Company (all products →)
Active substance: Risperidone
Dosage form: Powder and solvent for prolonged-release suspension for injection
Route of administration: Intramuscular use
ATC code: N05AX08
First authorised: 17/12/2002
Prescription status: Product subject to prescription which may not be renewed (A)
Supply: Supply through pharmacies only
Legal basis: Full application (Article 8(3) of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.