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Irish Medicines Database · HPRA register

Seroquel XR 400 mg prolonged-release tablets

Authorisation PPA0465/438/007 · PCO Manufacturing Ltd.

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Seroquel XR 400 mg prolonged-release tablets
Licence PPA0465/438/007 · Unknown
Licence holder
PCO Manufacturing Ltd. (all products →)
Active substance
Quetiapine
Dosage form
Prolonged-release tablet
Route of administration
Oral use
ATC code
N05AH04
First authorised
17/07/2026
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

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 16 Sep 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.