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Medicines
Netherlands
Edoxaban

CBG-MEB 2017

Edoxaban

Roteas 15 mg, filmomhulde tablet

Filmomhulde tabletNetherlandsAuthorisedAuthorised 20 Apr 2017

Product informationAsk Osler about it

On this page

In other countries
Documents
Sources and licences

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.

RoteasEuropean UnionAuthorised

RoteasBrazil · Daiichi Sankyo Brasil Farmacêutica LtdaSame brand
RoteasEuropean Union · Berlin-Chemie AGSame brand
RoteasCroatiaSame brand
ROTEAS 15 mgRomania · 15 mg · compr. film. · Berlin-Chemie AGSame brand
ROTEAS 30 mgRomania · 30 mg · compr. film. · Berlin-Chemie AGSame brand
ROTEAS 60 mgRomania · 60 mg · compr. film. · Berlin-Chemie AGSame brand

More with the same substance on this register

Edoxaban Cipla 15 mg, filmomhulde tablettenEdoxaban · Filmomhulde tabletNetherlands
Edoxaban Cipla 30 mg, filmomhulde tablettenEdoxaban · Filmomhulde tabletNetherlands

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Roteas®Serbia · 30mg · film tableta · Berlin-Chemie A. Menarini Distribution D.O.O.

Same brand

🇷🇸Roteas®Serbia · 15mg · film tableta · Berlin-Chemie A. Menarini Distribution D.O.O.Same brand

🇷🇸Roteas®Serbia · 60mg · film tableta · Berlin-Chemie A. Menarini Distribution D.O.O.Same brand

🇨🇦Jamp EdoxabanCanada · 60 MG · Tablet · Jamp Pharma CorporationSame form

🇨🇦Jamp EdoxabanCanada · 30 MG · Tablet · Jamp Pharma CorporationSame form

🇨🇦Pro-EdoxabanCanada · 30 MG · Tablet · Pro Doc LimiteeSame form

🇪🇸Lixiana 15 MG Comprimidos Recubiertos con PeliculaSpain · 20,205 mg · comprimido recubierto con película · Daiichi Sankyo Europe GmbhSame form

🇪🇸Lixiana 30 MG Comprimidos Recubiertos con PeliculaSpain · 40,410 mg · comprimido recubierto con película · Daiichi Sankyo Europe GmbhSame form

🇪🇸Lixiana 30 MG Comprimidos Recubiertos con PeliculaSpain · 40,410 mg · comprimido recubierto con película · Daiichi Sankyo Europe GmbhSame form

🇭🇷Cagluen 30 mg filmom obložene tableteCroatia · Filmom obložena tableta · Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, IrskaSame form

🇭🇷Cagluen 60 mg filmom obložene tableteCroatia · Filmom obložena tableta · Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, IrskaSame form

🇮🇹Edoxaban DR. Reddy'SItaly · Compressa rivestita con film · DR. Reddy'S S.R.L.Same form

🇮🇹Edoxaban HCSItaly · Compressa rivestita con film · HCS BVSame form

🇮🇹Edoxaban SandozItaly · Compressa rivestita con film · Sandoz S.P.A.Same form

🇸🇦LIXIANA 15 mg film coted tabletSaudi Arabia · Daiichi Sankyo Europe GmbHSame form

🇸🇦LIXIANA 30 mg film coted tabletSaudi Arabia · Daiichi Sankyo Europe GmbHSame form

🇸🇦LIXIANA 60 mg film coted tabletSaudi Arabia · Daiichi Sankyo Europe GmbHSame form

🇸🇬Lixiana Film-Coated Tablet 15 MGSingapore · 15 mg · tablet, film coated · A. Menarini Singapore Pte. LTD.Same form

🇸🇬Lixiana Film-Coated Tablet 30 MGSingapore · 30 mg · tablet, film coated · A. Menarini Singapore Pte. LTD.Same form

🇸🇬Lixiana Film-Coated Tablet 60 MGSingapore · 60 mg · tablet, film coated · A. Menarini Singapore Pte. LTD.Same form

🇺🇸SavaysaUnited States · 15MG BASE, 30MG BASE, 60MG BASE · tablet · Daiichi Sankyo INCSame form

🇺🇸EdoxabanUnited States · 15MG, 30MG, 60MG · tablet · Zydus Pharms USA INCSame form

🇧🇷Lixiana®Brazil · Daiichi Sankyo Brasil Farmacêutica LtdaSame substance

🇧🇷tosilato de edoxabanaBrazil · Eurofarma Laboratorios S.A.Same substance

🇪🇺LixianaEuropean Union · Daiichi Sankyo Europe GmbHSame substance

Documents

The official texts, at the regulator.

Summary of product characteristicsCBG-MEB
Register entryCBG-MEB

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

College ter Beoordeling van Geneesmiddelen

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: Edoxaban
Dosage form: Filmomhulde tablet
Route: Oraal gebruik
Register: Netherlands (CBG-MEB)
Status: Authorised
Status in the register: Ingeschreven
Authorised: 20 Apr 2017
Registration: EU/1/16/1152
Marketing authorisation holder: Berlin-Chemie AG, site Adlershof
ATC code: B01AF03
Group: Blood and blood-forming organs
Procedure: EU centralised
Supply: Uitsluitend recept
EMA product number: EMEA/H/C/004339
EU number: EU/1/16/1152

CBG-MEBEdoxaban Cipla 60 mg, filmomhulde tablettenEdoxaban · Filmomhulde tablet🇳🇱Netherlands

CBG-MEBEdoxaban G.L. Pharma 15 mg, filmomhulde tablettenEdoxaban · Filmomhulde tablet🇳🇱Netherlands

CBG-MEBEdoxaban G.L. Pharma 30 mg, filmomhulde tablettenEdoxaban · Filmomhulde tablet🇳🇱Netherlands

CBG-MEBEdoxaban G.L. Pharma 60 mg, filmomhulde tablettenEdoxaban · Filmomhulde tablet🇳🇱Netherlands

CBG-MEBEdoxaban HCS 15 mg filmomhulde tablettenEdoxaban · Filmomhulde tablet🇳🇱Netherlands

CBG-MEBEdoxaban HCS 30 mg filmomhulde tablettenEdoxaban · Filmomhulde tablet🇳🇱Netherlands

CBG-MEBEdoxaban HCS 60 mg filmomhulde tablettenEdoxaban · Filmomhulde tablet🇳🇱Netherlands

CBG-MEBEdoxaban Holsten 15 mg, filmomhulde tablettenEdoxaban · Filmomhulde tablet🇳🇱Netherlands

CBG-MEBEdoxaban Holsten 30 mg, filmomhulde tablettenEdoxaban · Filmomhulde tablet🇳🇱Netherlands

CBG-MEBEdoxaban Holsten 60 mg, filmomhulde tablettenEdoxaban · Filmomhulde tablet🇳🇱Netherlands