RISPERDAL 1 mg/ml oral solution

Authorisation PPA2306/007/001 · Originalis B.V.

Source: Health Products Regulatory Authority (HPRA), open dataset, CC BY 4.0. Published 07 Oct 2026

Maintained by Sreepriya Prasannan

MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist

Compiled from HPRA's official open dataset · Last verified 8 Oct 2026 · Editorial standards

Licence holder: Originalis B.V. (all products →)
Active substance: Risperidone
Clinical trials: 8 clinical trials →
Dosage form: Oral solution
Route of administration: Oral use
ATC code: N05AX08
First authorised: 21/12/2018
Prescription status: Product subject to prescription which may not be renewed (A)
Supply: Supply through pharmacies only
Legal basis: Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC

Risperidone: supply and approvals

40 authorised products on the HPRA list contain Risperidone. Shortage records below are for the substance in the EU, US and German markets and may not affect this Irish product; for Irish supply, check with the HPRA or a pharmacist.

EU shortage (EMA): Risperidone: Shortage ongoing, first published 19 Nov 2025
US shortage (FDA): No entry in the FDA drug shortage list (checked 7 Oct 2026)
Germany (BfArM): 13 supply notices, e.g. Risperidon AL 6 mg Filmtabletten (18 Jun 2026 to 26 Nov 2026)

Registers: EU shortages · US shortages · German shortages · EMA approvals

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.

How this page is built

The facts on this page are pulled directly from the HPRA's (Health Products Regulatory Authority) official open dataset — they are not written from memory, and nothing here is summarised or edited. Each field below names the dataset it came from, so you can check it yourself.

HPRA Authorised Medicines List (open data) ↗ Licence number, holder, active substance(s), dosage form, route, ATC code(s), authorisation date and prescription status for this product

This page is built automatically: a daily sync job downloads HPRA's published XML export and copies the licence number, holder, active substance(s), dosage form, route, ATC code(s), authorisation date and prescription status directly into this page — no AI drafting and no per-product editorial pass. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The HPRA data on this page was last retrieved on 8 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.