In other countries
The same active substances on other registers, the same brand first.
- PALEXIA 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULASpain · 116,48 mg · comprimido recubierto con película · Grünenthal Pharma S.A.Same brand
- PALEXIA 50 mg COMPRIMIDOS RECUBIERTOS CON PELICULASpain · 58,24 mg · comprimido recubierto con película · Grünenthal Pharma S.A.Same brand
- PALEXIA 75 mg COMPRIMIDOS RECUBIERTOS CON PELICULASpain · 87,36 mg · comprimido recubierto con película · Grünenthal Pharma S.A.Same brand
- Palexia 100 mg filmom obložene tableteCroatia · filmom obložena tableta · Grünenthal GmbH, Zieglerstraße 6, Aachen, NjemačkaSame brand
- Palexia 50 mg filmom obložene tableteCroatia · filmom obložena tableta · Grünenthal GmbH, Zieglerstraße 6, Aachen, NjemačkaSame brand
- Palexia 75 mg filmom obložene tableteCroatia · filmom obložena tableta · Grünenthal GmbH, Zieglerstraße 6, Aachen, NjemačkaSame brand
- Palexia 100 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Grünenthal B.V.Same brand
- Palexia 50 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Grünenthal B.V.Same brand
- Palexia 75 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Grünenthal B.V.Same brand
- Palexia®Serbia · 75mg · film tableta · Hemofarm Ad VRŠAcSame brand
- Palexia®Serbia · 50mg · film tableta · Hemofarm Ad VRŠAcSame brand
- Palexia®Serbia · 100mg · film tableta · Hemofarm Ad VRŠAcSame brand
- Nucynta Extended-ReleaseCanada · 200 MG · Tablet (Extended-Release) · Knight Therapeutics INC.Same form
- Nucynta Extended-ReleaseCanada · 50 MG · Tablet (Extended-Release) · Knight Therapeutics INC.Same form
- Nucynta Extended-ReleaseCanada · 100 MG · Tablet (Extended-Release) · Knight Therapeutics INC.Same form
- NucyntaUnited States · 100MG BASE, 50MG BASE, 75MG BASE · tablet · Collegium Pharm INCSame form
- Nucynta ERUnited States · 100MG BASE, 150MG BASE, 200MG BASE … · tablet, extended release · Collegium Pharm INCSame form
- Tapentadol HydrochlorideUnited States · 100MG, 100MG BASE, 50MG BASE … · tablet · Rhodes PharmsSame form
- PalexisBrazil · Grünenthal do Brasil Farmacêutica Ltda.Same substance
- Palexis® LPBrazil · Grünenthal do Brasil Farmacêutica Ltda.Same substance
- PalexisBrazil · Grünenthal do Brasil Farmacêutica Ltda.Same substance
Packs
| Pack | Code | Status |
|---|---|---|
| 50 MG COMPRESSE RIVESTITE CON FILM- 28 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423016 | Autorizzata |
| 50 MG COMPRESSE RIVESTITE CON FILM- 30 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423028 | Autorizzata |
| 50 MG COMPRESSE RIVESTITE CON FILM- 50 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423030 | Autorizzata |
| 50 MG COMPRESSE RIVESTITE CON FILM- 56 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423042 | Autorizzata |
| 50 MG COMPRESSE RIVESTITE CON FILM- 60 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423055 | Autorizzata |
| 50 MG COMPRESSE RIVESTITE CON FILM- 90 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423067 | Autorizzata |
| 50 MG COMPRESSE RIVESTITE CON FILM- 100 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423079 | Autorizzata |
| 75 MG COMPRESSE RIVESTITE CON FILM- 10 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423081 | Autorizzata |
| 75 MG COMPRESSE RIVESTITE CON FILM- 14 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423093 | Autorizzata |
| 75 MG COMPRESSE RIVESTITE CON FILM- 20 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423105 | Autorizzata |
| 75 MG COMPRESSE RIVESTITE CON FILM- 28 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423117 | Autorizzata |
| 75 MG COMPRESSE RIVESTITE CON FILM- 30 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423129 | Autorizzata |
| 75 MG COMPRESSE RIVESTITE CON FILM- 50 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423131 | Autorizzata |
| 75 MG COMPRESSE RIVESTITE CON FILM- 56 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423143 | Autorizzata |
| 75 MG COMPRESSE RIVESTITE CON FILM- 60 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423156 | Autorizzata |
| 75 MG COMPRESSE RIVESTITE CON FILM- 90 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423168 | Autorizzata |
| 75 MG COMPRESSE RIVESTITE CON FILM- 100 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423170 | Autorizzata |
| 100 MG COMPRESSE RIVESTITE CON FILM- 10 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423182 | Autorizzata |
| 100 MG COMPRESSE RIVESTITE CON FILM- 14 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423194 | Autorizzata |
| 100 MG COMPRESSE RIVESTITE CON FILM- 20 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423206 | Autorizzata |
| 100 MG COMPRESSE RIVESTITE CON FILM- 28 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423218 | Autorizzata |
| 100 MG COMPRESSE RIVESTITE CON FILM- 30 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423220 | Autorizzata |
| 100 MG COMPRESSE RIVESTITE CON FILM- 50 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423232 | Autorizzata |
| 100 MG COMPRESSE RIVESTITE CON FILM- 56 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423244 | Autorizzata |
| 100 MG COMPRESSE RIVESTITE CON FILM- 60 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423257 | Autorizzata |
| 100 MG COMPRESSE RIVESTITE CON FILM- 90 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423269 | Autorizzata |
| 100 MG COMPRESSE RIVESTITE CON FILM- 100 COMPRESSE IN BLISTER PVC/PVDC/AL MONODOSE | 040423271 | Autorizzata |
| 50 MG COMPRESSE A RILASCIO PROLUNGATO- 10 COMPRESSE IN BLISTER PVC/PVDC/AL/CARTA/PET MONODOSE | 040423283 | Autorizzata |
| 50 MG COMPRESSE A RILASCIO PROLUNGATO- 14 COMPRESSE IN BLISTER PVC/PVDC/AL/CARTA/PET MONODOSE | 040423295 | Autorizzata |
| 50 MG COMPRESSE A RILASCIO PROLUNGATO- 20 COMPRESSE IN BLISTER PVC/PVDC/AL/CARTA/PET MONODOSE | 040423307 | Autorizzata |
69 more packs are listed in the register.
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), Italy
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
- Tapentadol
- Dosage form
- Compressa a rilascio prolungato
- Register
- Italy (AIFA)
- Status
- Authorised
- Status in the register
- Autorizzata
- Registration
- AIC 040423
- Marketing authorisation holder
- Grunenthal Italia S.R.L.
- ATC code
- N02AX06
- Group
- Nervous system
- Procedure
- Procedura Mutuo riconoscimento o Decentrata
- Supply
- Medicinali soggetti a prescrizione medica da rinnovare volta per volta