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Irish Medicines Database · HPRA register

Austedo 48 mg prolonged-release tablets

Authorisation EU/1/25/1956/010-011 · TEVA GmbH

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Austedo 48 mg prolonged-release tablets
Licence EU/1/25/1956/010-011 · Unknown
Licence holder
TEVA GmbH (all products →)
Active substance
Deutetrabenazine
Dosage form
Prolonged-release tablet
Route of administration
Oral use
ATC code
N07XX16
First authorised
08/01/2026
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Known active substance (Article 8(3) of Directive No 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.