In other countries
The same active substances on other registers, the same brand first.
- Xtandi 40 MG Comprimidos Recubiertos con PeliculaSpain · 40 mg · comprimido recubierto con película · Astellas Pharma Europe B.V.Same form
- Enzalutamida Sandoz 40 MG Comprimidos Recubiertos con Pelicula EfgSpain · 40 mg · comprimido recubierto con película · Sandoz Farmaceutica S.A.Same form
- Enzalutamida Sandoz 80 MG Comprimidos Recubiertos con Pelicula EfgSpain · 80 mg · comprimido recubierto con película · Sandoz Farmaceutica S.A.Same form
- Enzalutamide AccordpharmaItaly · Compressa rivestita con film · Accord Healthcare, S.L.U.Same form
- Enzalutamide EgItaly · Compressa rivestita con film · Eg S.P.A.Same form
- Enzalutamide SandozItaly · Compressa rivestita con film · Sandoz S.P.A.Same form
- Enzalutamide 1A Pharma 160 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · 1A Pharma GmbHSame form
- Enzalutamide 1A Pharma 40 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · 1A Pharma GmbHSame form
- Enzalutamide 1A Pharma 80 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · 1A Pharma GmbHSame form
- Enzalutamid STADASerbia · 40mg · film tableta · Hemofarm Ad VRŠAcSame form
- Enzalutamid STADASerbia · 80mg · film tableta · Hemofarm Ad VRŠAcSame form
- Enzalutamid STADASerbia · 40mg · film tableta · Hemofarm Ad VRŠAcSame form
- Xtandi™ Film-Coated Tablets 40MGSingapore · 40mg · tablet, film coated · Astellas Pharma Singapore Pte. LTD.Same form
- Xtandi™ Film-Coated Tablets 80MGSingapore · 80mg · tablet, film coated · Astellas Pharma Singapore Pte. LTD.Same form
- XtandiUnited States · 40MG, 80MG · tablet · AstellasSame form
- EnzalutamideUnited States · 40MG, 80MG · tablet · Zydus Pharms USA INCSame form
- EnzalutamideUnited States · 40MG, 80MG · tablet · Hikma Pharmaceuticals USA INCSame form
- EnlutozaBrazil · DR. Reddys Farmacêutica do Brasil LtdaSame substance
- enzalutamidaBrazil · Accord Farmacêutica LtdaSame substance
- NindevBrazil · Accord Farmacêutica LtdaSame substance
- Apo-EnzalutamideCanada · 40 MG · Capsule · Apotex INCSame substance
- Auro-EnzalutamideCanada · 40 MG · Capsule · Auro Pharma INCSame substance
- Jamp EnzalutamideCanada · 40 MG · Capsule · Jamp Pharma CorporationSame substance
- Enzalutamide AccordpharmaEuropean Union · Accord HealthcareSame substance
- Enzalutamide ViatrisEuropean Union · Viatris LimitedSame substance
- XtandiEuropean Union · Astellas Pharma Europe B.V.Same substance
- XTANDI 40mgRomania · 40mg · caps. moi · Astellas Pharma Europe BVSame substance
- EnzastikSaudi Arabia · Eugia Pharma Specialties LimitedSame substance
- XTANDI 40 mg capsuleSaudi Arabia · Catalent Pharma SolutionsSame substance
- ALLUTAMIDE SOFT CAPSULES 40mgSingapore · 40 mg · capsule, liquid filled · Lotus International Pte. LTD.Same substance
- Inamide Soft Capsule 40MGTaiwan · 軟膠囊劑 · 美時化學製藥股份有限公司Same substance
Packs
| Pack | Code | Status |
|---|---|---|
| 112 tableta u blisteru, u kutiji | HR-H-701660007-01 | 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
- Enzalutamide
- Dosage form
- Filmom obložena tableta
- Register
- Croatia (HALMED)
- Status
- Not marketed
- Status in the register
- nije stavljeno u promet
- Authorised
- 5 Nov 2025
- Registration
- HR-H-701660007
- Marketing authorisation holder
- Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka
- Manufacturer
- Actavis International Ltd., Luqa, Malta Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska
- ATC code
- L02BB04
- Procedure
- National, MRP or DCP
- Supply
- na recept; u ljekarni