GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Daclatasvir and Sofosbuvir Tablets 60mg/400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Daclatasvir and Sofosbuvir Tablets 60mg/400mg
Each film-coated tablet contains:
Daclatasvir Dihydrochloride
Eq. to Daclatasvir …………………….60mg
Sofosbuvir ……………………………….400mg
Colour: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Daclatasvir is used along with another medication (sofosbuvir [Solvadi]) to treat a certain type of chronic hepatitis C (an ongoing viral infection that damages the liver). Daclatasvir is in a class of antiviral medications called hepatitis C virus (HCV) NS5A inhibitors.

CAUTION & WARNING:

CAUTION: 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.
DO NOT BREAK OR CRUSH TABLET
WARNING: To be sold by retail on the prescription of a “Gastroenterologists/Hepatologist Only”

STORAGE & DOSAGE:

Storage: Store protected from light and moisture & temperature not exceeding 30°C.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: As directed by the Physician.

Daclatasvir and Sofosbuvir Tablets 60mg/400mg Technical Specification

Product Name:Daclatasvir and Sofosbuvir Tablets
Brand Name:Generic
Strength:60mg/400mg
Dosage Form:Film-coated Oral Tablets
Route of Administration:Via Oral Route
Packing:28s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Treatment of Chronic hepatitis C
Indication: Daclatasvir is used along with another medication (sofosbuvir [Solvadi]) to treat a certain type of chronic hepatitis C (an ongoing viral infection that damages the liver). Daclatasvir is in a class of antiviral medications called hepatitis C virus (HCV) NS5A inhibitors
Storage:Store protected from light and moisture & temperature not exceeding 30°C.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Daclatasvir and Sofosbuvir Tablets 60mg/400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Daclatasvir and Sofosbuvir Tablets 60mg/400mg
    Each film-coated tablet contains:

    Daclatasvir Dihydrochloride
    Eq. to Daclatasvir …………………….60mg
    Sofosbuvir ……………………………….400mg
    Colour: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Daclatasvir is used along with another medication (sofosbuvir [Solvadi]) to treat a certain type of chronic hepatitis C (an ongoing viral infection that damages the liver). Daclatasvir is in a class of antiviral medications called hepatitis C virus (HCV) NS5A inhibitors.

CAUTION & WARNING:

CAUTION:  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.
DO NOT BREAK OR CRUSH TABLET
Warning: To be sold by retail on the prescription of a “Gastroenterologists/Hepatologist Only”

STORAGE & DOSAGE:

Storage: Store protected from light and moisture & temperature not exceeding 30°C.
Read enclosed leaflet before use.
Keep medicine out of reach of children.
Dosage: As directed by the Physician.