Medicine guide

Roteas

·

  • Prescription status not stated
  • Blood, clotting and anaemia
Active substance
Edoxaban
Made by
Berlin-Chemie AG

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

  • Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

EMA’s data export replaced some characters it could not represent (for example “≥”) with “?”. The text is shown exactly as exported; the wording on the EMA page is authoritative.

From the official label · 2026-09-30 · European Medicines Agency

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

BulgariaNo exact match for this strength and form

SpainNo exact match for this strength and form

CanadaNo exact match for this strength and form

NetherlandsNo exact match for this strength and form

SwitzerlandNo exact match for this strength and form

Details

Made byBerlin-Chemie AG
Active substanceEdoxaban
Used inBlood, clotting and anaemia
ClassificationB01AF03 · Blood, clotting and anaemia
Authorised on2017-04-19
Last updated by the regulator2026-04-20
EMA product numberEMEA/H/C/004339

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.