In other countries
The same active substances on other registers, the same brand first.
Authorised centrally in the EU
This national listing belongs to a medicine the European Commission authorised for the whole EU.
- 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 + 20 MG + 10 MG · Tablet · Auro Pharma INCSame form
- Auro-ApremilastCanada · 30 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 Belupo 10 mg, 20 mg i 30 mg filmom obložene tableteCroatia · Filmom obložena tableta · Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, HrvatskaSame form
- Apremilast Belupo 30 mg filmom obložene tableteCroatia · Filmom obložena tableta · Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, HrvatskaSame form
- Apremilast Sandoz 10 mg, 20 mg i 30 mg filmom obložene tableteCroatia · Filmom obložena tableta · Sandoz d.o.o., Maksimirska 120, Zagreb, HrvatskaSame 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
- 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 · Amgen Biotecnologia do Brasil Ltda.Same substance
- OtezlaBrazil · Celgene Brasil Produtos Farmacêuticos 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. · Celgene Europe B.V.Same substance
- OtezlaRomania · 30mg · compr. film. · Amgen Europe BVSame substance
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.
College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.
Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim · 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
- Filmomhulde tablet
- Route
- Oraal gebruik
- Register
- Netherlands (CBG-MEB)
- Status
- Authorised
- Status in the register
- Ingeschreven
- Authorised
- 19 Apr 2024
- Registration
- EU/1/24/1796
- Marketing authorisation holder
- Accord Healthcare S.L.U.
- ATC code
- L04AA32
- Procedure
- EU centralised
- Supply
- Uitsluitend recept
- EMA product number
- EMEA/H/C/006208
- EU number
- EU/1/24/1796