Rivaroxaban

Rivaroxaban

• Innovative crystallization resulting in high-purity material
• No risk of nitrosamines presence
• Highly efficient process

Status	Commercial
Therapeutic cat.	Blood Forming
Polymorphic form	Modification I
CAS No.	366789-02-8
EU DMF readiness
CEP
CHINESE  DMF
KOREAN  DMF
BRAZILIAN DMF
CANADIAN  DMF
CADIFA
US DMF readiness

Drug description

Rivaroxaban is used to treat or prevent blood clots (venous thromboembolism, or VTE). Blood clots can occur in the legs (deep vein thrombosis, DVT) or the lungs (pulmonary embolism, PE).Rivaroxaban is sometimes used to lower your risk of a blood clot coming back after you have received treatment for blood clots for at least 6 months in adults, and at least 5 days in children from birth to less than 18 years of age.Rivaroxaban is also given together with aspirin to lower the risk of stroke, heart attack, or other serious heart and blood circulation problems in adults with coronary artery disease (clogged arteries) or peripheral artery disease (reduced blood flow to the legs), including adults who recently had a procedure to improve blood flow to the legs.Rivaroxaban can also be used to prevent blood clots in adults that are not able to move as normal during and after a hospital stay or after a hip or knee replacement surgery.Rivaroxaban can be used to prevent blood clots in children 2 years and older that have undergone surgery for a heart disease present at birth.

Disclaimer: Products protected by patents (SPC) in Poland are developed solely for the purpose of Regulatory Submissions or R&D purposes intended to support Regulatory Submissions. These products are not offered for sale or made available in countries where such products are subject to patent (SPC) protection and where the offer for sale or any related activity constitutes patent infringement. It is within the buyer’s responsibility and liability to check the patent situation of the product in the import market(s). Based on exemption under art. 5(2) of the Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products Apixaban, Dapagliflozin (amorphous), Linagliptin, Rivaroxaban and Ticagrelor, which are protected by SPCs in Poland, can be manufactured and offered only for the purpose of export to non-EU countries, provided all requirements of the Regulationare met.