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Rivaroxaban

CAS No.

366789-02-8

Reference product

XARELTO/BAYER

Polymorphic form

Modification I

Rivaroxaban

Therapeutic Area

Blood & blood forming organs

Status

pipeline

EU DMF readiness

US DMF readiness

027661

Other documentation

Chinese DMF
Korean DMF

Drug description:

Rivaroxaban belongs to the class of antithrombotic agents. Rivaroxaban reduces a risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack. It is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
It is formulated as film-coated tablet and tablet for oral administration.

Mechanism of action:

Rivaroxaban is a factor Xa inhibitor. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombus. By blocking factor Xa, the level of thrombin decreases, which reduces the risk of blood clots forming in the veins and arteries, and also treats existing clots.

DISCLAIMER
The above product is presented solely for informational purposes and does not constitute an offer in any sense. Products with PIPELINE & EARLY DEVELOPMENT STATUS under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.

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