PRODUCT DETAIL

Rivaroxaban Richter 15 mg filmom obalené tablety, Rivaroxaban Richter 20 mg filmom obalené tablety

Code

9012D

MA number

16/0291/21-S

Product Form:

tbl flm 49(42x15mg+7x20mg) (blis.PVC/PVDC/Al)

MA Status:

R - Valid Marketing Authorisation

Type of procedure:

Decentralised

MAH, country:

Adalvo Limited, Malta

Therapeutic Class:

16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)

ATC:

B	BLOOD AND BLOOD FORMING ORGANS
B01	ANTITHROMBOTIC AGENTS
B01A	ANTITHROMBOTIC AGENTS
B01AF	Direct factor Xa inhibitors
B01AF01	Rivaroxaban

Shelf life:

Container:

blister PVC/PVDC/Al

Route of admin.:

Oral use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 10(1) generic application
MA issued:	02.12.2021
Validity:	02.12.2026
PIL:	PIL_Rivaroxaban Richter 15 mg filmom obalené tablety, Rivaroxaban Richter 20 mg filmom obalené tablety _11.2023.pdf
SPC:	SPC_Rivaroxaban Richter 15 mg filmom obalené tablety, Rivaroxaban Richter 20 mg filmom obalené tablety _11.2023.pdf
Safety feature	Yes
Data update:	10.12.2021