In other countries
The same active substances on other registers, the same brand first.
- FacemilArgentina · 10 MG - 20 MG - 30 MG, 30 MG · comprimido recubierto · Tuteur S.A.C.I.F.I.A.Same form
- Apo-ApremilastCanada · 30 MG · Tablet · Apotex INCSame form
- Auro-ApremilastCanada · 30 MG · Tablet · Auro Pharma INCSame form
- Auro-ApremilastCanada · 30 MG + 20 MG + 10 MG · Tablet · Auro Pharma INCSame form
- Apremilast Accord 10 MG + 20 MG + 30 MG Comprimidos Recubiertos con Pelicula EfgSpain · 10 mg + 20 mg + 30 mg · comprimido recubierto con película · Accord Healthcare S.L.U.Same form
- Apremilast Accord 30 MG Comprimidos Recubiertos con Pelicula EfgSpain · 30 mg · comprimido recubierto con película · Accord Healthcare S.L.U.Same form
- Apremilast DR. Reddys 10MG + 20MG + 30MG Comprimidos Recubiertos con Pelicula EfgSpain · 10 mg + 20 mg + 30 mg · comprimido recubierto con película · Reddy Pharma Iberia S.A.Same form
- Apremilast AccordItaly · Compressa rivestita con film · Accord Healthcare, S.L.U.Same form
- Apremilast Day ZeroItaly · Compressa rivestita con film · Day Zero EhfSame form
- Apremilast DR.Reddy?SItaly · Compressa rivestita con film · DR. Reddy'S S.R.L.Same form
- Apremilast Accord 10 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare S.L.U.Same form
- Apremilast Accord 20 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare S.L.U.Same form
- Apremilast Accord 30 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare S.L.U.Same form
- Apriva 10 mg 4 tablets + 20 mg 4 tablets + 30 mg 20 tabletsSaudi Arabia · Jazeera Pharmaceutical Industries (JPI)Same form
- OTEZLA 10 mg 4 tablets + 20 mg 4 tablets + 30 mg 19 tabletsSaudi Arabia · Patheon INCSame form
- Otezla 30MG F.C.TabSaudi Arabia · Patheon INCSame form
- Otezla Tablet 30 MGSingapore · 30 mg · tablet, film coated · Amgen Biotechnology Singapore Pte LTDSame form
- Otezla Tablet Starter PackSingapore · 30 mg + 20 mg + 10 mg · tablet, film coated · Amgen Biotechnology Singapore Pte LTDSame form
- ApremilastUnited States · 10MG, 20MG, 30MG · tablet · DR ReddysSame form
- OtezlaUnited States · 10MG, 20MG, 30MG · tablet · Celgene CorpSame form
- Otezla XRUnited States · 75MG · tablet, extended release · Amgen INCSame form
- EpitBrazil · Apsen Farmaceutica S/ASame substance
- OtezlaBrazil · Celgene Brasil Produtos Farmacêuticos Ltda.Same substance
- OtezlaBrazil · Amgen Biotecnologia do Brasil Ltda.Same substance
- Apremilast AccordEuropean Union · Accord Healthcare S.L.U.Same substance
- OtezlaEuropean Union · Amgen Europe B.V.Same substance
- Apremilast ViatrisEuropean Union · Viatris LimitedSame substance
- OtezlaRomania · 30mg · compr. film. · Amgen Europe BVSame substance
- OtezlaRomania · 30mg · compr. film. · Celgene Europe B.V.Same substance
Packs
| Pack | Code | Status |
|---|---|---|
| 56 tableta u blisteru, u kutiji | HR-H-355474839-01 | 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
- Apremilast
- Dosage form
- Filmom obložena tableta
- Register
- Croatia (HALMED)
- Status
- Not marketed
- Status in the register
- nije stavljeno u promet
- Authorised
- 31 Jan 2025
- Registration
- HR-H-355474839
- Marketing authorisation holder
- Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska
- Manufacturer
- Labormed - Pharma S.A., 3rd District, Bukurešt, Rumunjska
- ATC code
- L04AA32
- Procedure
- National, MRP or DCP
- Supply
- na recept; u ljekarni