In other countries
The same active substances on other registers, the same brand first.
- TemgesicBrazil · Hypera S.A.Same brand
- TemgesicBrazil · Mantecorp Indústria Química e Farmacêutica S.A.Same brand
- Temgesic 0,2 mg, tabletten voor sublinguaal gebruikNetherlands · Tablet voor sublinguaal gebruik · Medcor Pharmaceuticals B.V.Same brand
- Temgesic 0,2 mg tabletten voor sublinguaal gebruikNetherlands · Tablet voor sublinguaal gebruik · Eumedica Pharmaceuticals GmbHSame brand
- Temgesic 0,3 mg/ml oplossing voor injectieNetherlands · Oplossing voor injectie · Eumedica Pharmaceuticals GmbHSame brand
- BUPREX 0,2 mg COMPRIMIDOS SUBLINGUALESSpain · 0,216 mg · comprimido sublingual · Eumedica Pharmaceuticals GmbhSame form
- Buprenorfin Alkaloid 2 mg sublingvalne tableteCroatia · sublingvalna tableta · Alkaloid d.o.o., Slavonska avenija 6 A, Zagreb, HrvatskaSame form
- Buprenorfin Alkaloid 8 mg sublingvalne tableteCroatia · sublingvalna tableta · Alkaloid d.o.o., Slavonska avenija 6 A, Zagreb, HrvatskaSame form
- Buprenorfin Sandoz 2 mg sublingvalne tableteCroatia · sublingvalna tableta · Sandoz d.o.o., Maksimirska 120, Zagreb, HrvatskaSame form
- Buprenorfin Alkaloid®Serbia · 8mg · sublingvalna tableta · Alkaloid D.O.O. BeogradSame form
- Buprenorfin Alkaloid®Serbia · 8mg · sublingvalna tableta · Alkaloid D.O.O. BeogradSame form
- Buprenorfin Alkaloid®Serbia · 2mg · sublingvalna tableta · Alkaloid D.O.O. BeogradSame form
- Buprenorphine HydrochlorideUnited States · 2MG BASE, 8MG BASE · tablet · Rubicon ResearchSame form
- SubutexUnited States · 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet · IndiviorSame form
- buprenorfinaBrazil · Adium S.A.Same substance
- Butrans 10Canada · 10 MCG / HOUR · Patch · Purdue PharmaSame substance
- Butrans 15Canada · 15 MCG / HOUR · Patch · Purdue PharmaSame substance
- Butrans 20Canada · 20 MCG / HOUR · Patch · Purdue PharmaSame substance
- Buprenorfina Andromaco 35 Microgramos/Hora Parche Transdermico EfgSpain · 20 mg · parche transdérmico · Andromaco Pharma S.L.Same substance
- Buprenorfina Andromaco 52,5 Microgramos/Hora Parche Transdermico EfgSpain · 30 mg · parche transdérmico · Andromaco Pharma S.L.Same substance
- Buprenorphine NeuraxpharmEuropean Union · Neuraxpharm Pharmaceuticals S.L.Same substance
- BuvidalEuropean Union · Camurus ABSame substance
- SixmoEuropean Union · L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.Same substance
- BUTRANS 10 mcg/hour transdermal patchSaudi Arabia · LTS LOHMANN Therapie-SystemeSame substance
- BUTRANS 20 mcg/hour transdermal patchSaudi Arabia · LTS LOHMANN Therapie-SystemeSame substance
- BUTRANS 5 mcg/hour transdermal patchSaudi Arabia · LTS LOHMANN Therapie-SystemeSame substance
- Desud Sublingual Tablets 8mgTaiwan · 舌下錠 · 美時化學製藥股份有限公司Same substance
- Transtec 35ug/h, transdermal patchTaiwan · 穿皮貼片劑 · 台灣萌蒂藥品有限公司Same substance
- BelbucaUnited States · 0.075MG BASE, 0.15MG BASE, 0.3MG BASE … · film · BdsiSame substance
Packs
| Pack | Code | Status |
|---|---|---|
| 0,3MG/ML SOLUZIONE INIETTABILE- 5 FIALE | 025215017 | Autorizzata |
| 0,2MG COMPRESSE SUBLINGUALI- 10 COMPRESSE | 025215029 | Autorizzata |
| 0,2 MG COMPRESSE SUBLINGUALI- 10 COMPRESSE IN BLISTER NYLON/AL/PVC | 025215043 | Autorizzata |
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
Agenzia Italiana del Farmaco (AIFA); https://drive.aifa.gov.it/farmaci/confezioni_fornitura.csv; HTTP Last-Modified Mon, 12 Oct 2026 23:02:44 GMT; acquired 2026-10-13T17:21:16.224007+00:00; native fields retained, source identifier and role projections are adaptations.
Licence: CC BY 4.0; AIFA published open-data catalog · Added 13 Oct 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substance
- Buprenorphine
- Dosage form
- Compressa sublinguale
- Register
- Italy (AIFA)
- Status
- Authorised
- Status in the register
- Autorizzata
- Registration
- AIC 025215
- Marketing authorisation holder
- Eumedica Pharmaceuticals GMBH
- ATC code
- N02AE01
- Group
- Nervous system
- Procedure
- Procedura Nazionale
- Supply
- Medicinali soggetti a prescrizione medica speciale con Ricetta Ministeriale a Ricalco



