Rivaroxaban Tablets 2.5mg
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Rivaroxaban Tablets 2.5mg Technical Specification:

Product Name: Rivaroxaban Tablets 2.5mg
Brand Name: Generic
Strength: (2.5mg),  (10mg), (15mg), (20mg)
Dosage Form: Tablets (Film-coated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Anticoagulant
Indication: Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery; prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; treatment of deep vein thrombosis (DVT) and pulmonary.
Storage: Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Rivaroxaban Tablets 2.5mg
    Each Film-coated tablet contains:
    Rivaroxaban………2.5mg
    Excipients…………..q.s
    Colour: Ferric Oxide yellow USP-NF, Titanium Dioxide IP
  • Rivaroxaban Tablets 10mg
    Each Film-coated tablet contains:
    Rivaroxaban………10mg
    Excipients…………..q.s
    Colour: Red oxide of iron & Titanium Dioxide IP
  • Rivaroxaban Tablets 15mg
    Each Film-coated tablet contains:
    Rivaroxaban………15mg
    Excipients…………..q.s
    Colour: Red oxide of iron & Titanium Dioxide IP
  • Rivaroxaban Tablets 20mg
    Each Film-coated tablet contains:
    Rivaroxaban………20mg
    Excipients…………..q.s
    Colour: Ferric Oxide RED USP-NF, Titanium Dioxide IP 

THERAPEUTIC INDICATIONS:

Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery; prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; treatment of deep vein thrombosis (DVT) and pulmonary.

CAUTION & WARNING:

CAUTION:

Read enclosed leaflet before use.

Keep medicine out of reach of children.

SWALLOW WHOLE DO NOT CHEW OR CRUSH.

WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F)

Store in dry place protected from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

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
Each Film-coated tablet contains:
Rivaroxaban………2.5mg
Excipients…………..q.s
Colour: Ferric Oxide yellow USP-NF, Titanium Dioxide IP

B. Rivaroxaban Tablets 10mg
Each Film-coated tablet contains:
Rivaroxaban………10mg
Excipients…………..q.s
Colour: Red oxide of iron & Titanium Dioxide IP

C. Rivaroxaban Tablets 15mg
Each Film-coated tablet contains:
Rivaroxaban………15mg
Excipients…………..q.s
Colour: Red oxide of iron & Titanium Dioxide IP

D. Rivaroxaban Tablets 20mg
Each Film-coated tablet contains:
Rivaroxaban………20mg
Excipients…………..q.s
Colour: Ferric Oxide RED USP-NF, Titanium Dioxide IP

THERAPEUTIC INDICATIONS:

Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery; prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; treatment of deep vein thrombosis (DVT) and pulmonary..

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician
Attach dispensing label as per end country.