GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Sofosbuvir & Velpatasvir Tablets 400mg+100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a. Sofosbuvir & Velpatasvir Tablets 400mg+100mg
Each film-coated tablet contains:
Sofosbuvir ………….400mg
Velpatasvir………….100mg
Excipients…….…. q. s
Color: Red Oxide of Iron & Titanium Dioxide USP
Each film-coated tablet contains:
Sofosbuvir ………….400mg
Velpatasvir………….100mg
Excipients…….…. q. s
Color: Red Oxide of Iron & Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Sofosbuvir and velpatasvir combination is used with or without ribavirin to treat chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 infections (including with or without cirrhosis).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Do not use if seal over bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Keep store in tightly closed container.
Dispense in original container.
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.
Read enclosed leaflet before use.
Do not use if seal over bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Keep store in tightly closed container.
Dispense in original container.
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 a temperature not exceeding 30°C.
Protect from light & Moisture.
DOSAGE: As directed by the HEPATOLOGIST.
Attach dispensing label as per end country.
Protect from light & Moisture.
DOSAGE: As directed by the HEPATOLOGIST.
Attach dispensing label as per end country.
Sofosbuvir & Velpatasvir Tablets (400mg+100mg) Technical Specification:
| Product Name: | Sofosbuvir & Velpatasvir Tablets |
| Brand Name: | Generic |
| Strength: | 400mg+100mg |
| 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: | HEPATITIS C TREATMENT |
| Indication: | Sofosbuvir and velpatasvir combination is used with or without ribavirin to treat chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 infections (including with or without cirrhosis). |
| Storage: | Store at a temperature not exceeding 30°C. Protect from light & Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Sofosbuvir & Velpatasvir Tablets 400mg+100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Sofosbuvir & Velpatasvir Tablets 400mg+100mg
Each film-coated tablet contains:
Sofosbuvir ………….400mg
Velpatasvir………….100mg
Excipients…….…. q. s
Color: Red Oxide of Iron & Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Sofosbuvir and velpatasvir combination is used with or without ribavirin to treat chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 infections (including with or without cirrhosis).
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Do not use it if the seal over the bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Keep stored in a tightly closed container.
Dispense in original container.
Keep the 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 a temperature not exceeding 30°C.
Protect from light & Moisture.
DOSAGE:
As directed by the HEPATOLOGIST.
Attach dispensing label as per end country.
