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Suboxone 4 mg/1 mg Sublingual film
Licence EU/1/06/359/010-012 · Unknown
- Licence holder
- Indivior Europe Limited (all products →)
- Active substances
- Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate
- Dosage form
- Sublingual film
- Routes of administration
- Buccal use, Sublingual use
- ATC code
- N07BC51
- First authorised
- 03/07/2020
- 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.