RIVAROXABAN ACCORD
As listed in the register: RIVAROXABAN ACCORD 15 mg, comprimé pelliculé
15,0 mg · comprimé pelliculé
- Prescription only
- Active substance
- Rivaroxaban
- Made by
- ACCORD HEALTHCARE (ESPAGNE)
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (rivaroxaban). It describes the substance, not this Bulgarian product — its uses and doses can differ.
XARELTO is a selective inhibitor of FXa.
It does not require a cofactor (such as Anti-thrombin III) for activity.
Unchanged drug is excreted into urine, mainly via active tubular secretion and to a lesser extent via glomerular filtration (approximate 5:1 ratio).
For the 2.5 mg and 10 mg dose, it is estimated to be 80% to 100% and is not affected by food.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-09-10
Safety of the active substance
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (rivaroxaban). It describes the substance, not this Bulgarian product — its uses and doses can differ.
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA A.
- XARELTO is contraindicated in patients with: active pathological bleeding [see Warnings and Precautions (5.2) ] severe hypersensitivity reaction to XARELTO (e.g., anaphylactic reactions) [see Adverse Reactions (6.2) ] Active pathological bleeding ( 4 ) Severe hypersensitivity reaction to XARELTO ( 4 )
The most common adverse reactions with XARELTO were bleeding complications [see Warnings and Precautions (5.2) ].
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
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
United StatesNo exact match for this strength and form
BulgariaNo exact match for this strength and form
European UnionNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | ACCORD HEALTHCARE (ESPAGNE) |
|---|---|
| Active substance | Rivaroxaban |
| Strength | 15,0 mg |
| Form | comprimé pelliculé |
| Route | orale |
| Dispensing (as stated by the register) | liste I |
| Marketed | Yes, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/20/1488 |
| Name in the register | RIVAROXABAN ACCORD 15 mg, comprimé pelliculé |
| Packs | plaquette(s) PVC aluminium de 28 comprimé(s) |
| CIS | 68216702 |
| CIP13 | 3400930278352 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).
Other strengths and forms
3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.