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Irish Medicines Database · HPRA register

Mysimba 8 mg/90 mg prolonged-release tablets

Authorisation EU/1/14/988/001-002 · Orexigen Therapeutics Ireland Limited

← All medicines
Mysimba 8 mg/90 mg prolonged-release tablets
Licence EU/1/14/988/001-002 · Unknown
Licence holder
Orexigen Therapeutics Ireland Limited (all products →)
Active substances
Naltrexone hydrochloride, Bupropion hydrochloride
Dosage form
Prolonged-release tablet
Route of administration
Oral use
ATC codes
A08AA, A08AA62
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Fixed combination application (Article 10b 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.