GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Rivaroxaban Tablets (2.5mg)
B. Rivaroxaban Tablets (10mg)
C. Rivaroxaban Tablets (15mg)
D. Rivaroxaban Tablets (20mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Rivaroxaban Tablets (2.5mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………2.5mg
Excipients…………………………………. q.s.
Colours: Titanium Dioxide USP


B. Rivaroxaban Tablets (10mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………10mg
Excipients…………………………………. q.s.
Colours: Ferric Oxide Red USP-NF

C. Rivaroxaban Tablets (15mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………15mg
Excipients…………………………………. q.s.
Colours: Iron Oxide Yellow

D. Rivaroxaban Tablets (20mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………20mg
Excipients…………………………………. q.s.
Colours: Iron Oxide Black

THERAPEUTIC INDICATIONS:

Rivaroxaban Tablet is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge.

CAUTION & WARNING:

CAUTION: Do not throw away consumer package insert.
Swallow whole do not chew or crush.
PHARMACIST: Please dispense with medication guide provided separately.
WARNING: To be sold by retail on the prescription of a psychiatrist only.
Medicinal product subject to medical prescription.
Prescription medicines once daily.
Keep out of the reach and sight of children.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 25°C.
Dosage: As directed by the Physician.

Rivaroxaban Tablets 2.5mg Technical Specification:

Product Name:Rivaroxaban Tablet 2.5mg
Brand Name:Ravetaj
Strength:2.5mg, 10mg, 15mg, 20mg
Dosage Form:Film-coated tablets
Packing:5s Blisters, 7s Blisters, 10s Blisters, 14s Blisters, 28s Blisters, 98s Blisters
Route of Administration:For Oral Use Only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anticoagulants, Cardiovascular
Indication: Rivaroxaban Tablet is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge.
Storage:Store protected from moisture at a temperature not exceeding 25°C.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Rivaroxaban Tablets (2.5mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Rivaroxaban Tablets (2.5mg)
    Composition:
    Each film-coated tablet contains:
    Rivaroxaban ………………………………2.5mg
    Excipients…………………………………. q.s.
    Colours: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Rivaroxaban Tablet is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge.

CAUTION & WARNING:

CAUTION: Do not throw away consumer package insert.

Swallow whole do not chew or crush.

PHARMACIST: Please dispense with medication guide provided separately.

WARNING: To be sold by retail on the prescription of a psychiatrist only.

Medicinal product subject to medical prescription.
Prescription medicines once daily.

Keep out of the reach and sight of children.

STORAGE & DOSAGE:

Storage:  Store protected from moisture at a temperature not exceeding 25°C.

Dosage: As directed by the Physician.