In other countries
The same active substances on other registers, the same brand first.
- Nucynta Extended-ReleaseCanada · 150 MG · Tablet (Extended-Release) · Knight Therapeutics INC.Same form
- Nucynta Extended-ReleaseCanada · 200 MG · Tablet (Extended-Release) · Knight Therapeutics INC.Same form
- Nucynta Extended-ReleaseCanada · 250 MG · Tablet (Extended-Release) · Knight Therapeutics INC.Same form
- PALEXIA 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULASpain · 116,48 mg · comprimido recubierto con película · Grünenthal Pharma S.A.Same form
- PALEXIA 50 mg COMPRIMIDOS RECUBIERTOS CON PELICULASpain · 58,24 mg · comprimido recubierto con película · Grünenthal Pharma S.A.Same form
- PALEXIA 75 mg COMPRIMIDOS RECUBIERTOS CON PELICULASpain · 87,36 mg · comprimido recubierto con película · Grünenthal Pharma S.A.Same form
- PalexiaItaly · Compressa a rilascio prolungato · Grunenthal Italia S.R.L.Same form
- PalexiaItaly · Compressa a rilascio prolungato · Grunenthal Italia S.R.L.Same form
- PalexiaItaly · Compressa a rilascio prolungato · Grunenthal Italia S.R.L.Same form
- Dolten 100 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Medochemie LimitedSame form
- Dolten 50 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Medochemie LimitedSame form
- Dolten 75 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Medochemie LimitedSame form
- Apeneta®Serbia · 50mg · tableta sa produženim oslobađanjem · Krka-Farma D.O.O. BeogradSame form
- Apeneta®Serbia · 150mg · tableta sa produženim oslobađanjem · Krka-Farma D.O.O. BeogradSame form
- Apeneta®Serbia · 100mg · tableta sa produženim oslobađanjem · Krka-Farma D.O.O. BeogradSame 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 |
|---|---|---|
| 20 tableta u blisteru s jediničnom dozom, u kutiji | HR-H-936529113-01 | nije stavljeno u promet |
| 24 tablete u blisteru s jediničnom dozom, u kutiji | HR-H-936529113-02 | nije stavljeno u promet |
| 30 tableta u blisteru s jediničnom dozom, u kutiji | HR-H-936529113-03 | nije stavljeno u promet |
| 50 tableta u blisteru s jediničnom dozom, u kutiji | HR-H-936529113-04 | nije stavljeno u promet |
| 54 tablete u blisteru s jediničnom dozom, u kutiji | HR-H-936529113-05 | nije stavljeno u promet |
| 60 tableta u blisteru s jediničnom dozom, u kutiji | HR-H-936529113-06 | stavljeno u promet |
| 100 tableta u blisteru s jediničnom dozom, u kutiji | HR-H-936529113-07 | nije stavljeno u promet |
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
HALMED — Agencija za lijekove i medicinske proizvode RH
HALMED, Baza lijekova, source export 08.10.2026., acquired 2026-10-08; factual structured adaptation; Otvorena dozvola RH, NN 67/2017.
Licence: Otvorena dozvola RH NN 67/2017 · Added 8 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
- Tableta s produljenim oslobađanjem
- Register
- Croatia (HALMED)
- Status
- Marketed
- Status in the register
- stavljeno u promet; nema nestašice
- Authorised
- 17 Oct 2022
- Registration
- HR-H-936529113
- Marketing authorisation holder
- Stada d.o.o., Hercegovačka 14, Zagreb, Hrvatska
- Manufacturer
- Develco Pharma GmbH, Schopfheim, Njemačka<br/>STADA Arzneimittel AG, Bad Vilbel, Njemačka
- ATC code
- N02AX06
- Group
- Nervous system
- Procedure
- National, MRP or DCP
- Supply
- na recept; u ljekarni