Favipiravir Tablets 200mg Technical Specification:

Product Name:Favipiravir Tablets 200mg
Brand Name:Fabitaj
Strength:200mg, 400mg, 800mg
Dosage Form:Film-coated Tablet
Packing:10s, 17s, 34s
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:Antiviral
Indication: Favipiravir is uses in the treatment of influenza, Ebola and other pathogenic viral infections. It is also being studied to treat a number of other viral infections, including SARS-CoV-2
Storage:Store at a temperature not exceeding 25°C. Protect from moisture

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Favipiravir Tablets 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Favipiravir Tablets 200mg
    Each film-coated tablet contains:
    Favipiravir……………………….200mg
    Excipients………………………. q.s.
    Colours: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Favipiravir is uses in the treatment of influenza, Ebola and other pathogenic viral infections. It is also being studied to treat a number of other viral infections, including SARS-CoV-2.

Favipiravir tablets used for the treatment of mild to moderate COVID-19 disease in adults under restricted emergency use.

CAUTION & WARNING:

CAUTION: Swallow complete tablet, do not crush or chew.

Read enclosed leaflet before use.

Keep medicine out of reach of children.

Warning: Do not administer the drug to women known or suspected to be pregnant

Warning: Male patient should use most effective contraceptive methods in sexual intercourse during and for 7 days after the end of treatment.

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

STORAGE & DOSAGE:

Storage:  Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Dosage:  As directed by the Physician.

Attach dispensing label as per end country.

NOTE: 14-day oral administration of favipiravir at a dose of 30 mg/kg/day.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Favipiravir Tablets 200mg
B. Favipiravir Tablets 400mg
C. Favipiravir Tablets 800mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Favipiravir Tablets 200mg
Each film-coated tablet contains:
Favipiravir………………...…….200mg
Excipients………………………. q.s.
Colours: Titanium Dioxide USP


B. Favipiravir Tablets 400mg
Each film-coated tablet contains:
Favipiravir……………….…….400mg
Excipients………………………. q.s.
Colours: Red oxide of Iron

C. Favipiravir Tablets 800mg
Each film-coated tablet contains:
Favipiravir……………….…….800mg
Excipients………………………. q.s.
Colours: Yellow oxide of Iron

THERAPEUTIC INDICATIONS:

Favipiravir is uses in the treatment of influenza, Ebola and other pathogenic viral infections. It is also being studied to treat a number of other viral infections, including SARS-CoV-2.
Favipiravir tablets used for the treatment of mild to moderate COVID-19 disease in adults under restricted emergency use.

CAUTION & WARNING:

CAUTION: Swallow complete tablet, do not crush or chew.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: Do not administer the drug to women known or suspected to be pregnant.
WARNING: Male patient should use most effective contraceptive methods in sexual intercourse during and for 7 days after the end of treatment.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
NOTE: 14-day oral administration of favipiravir at a dose of 30 mg/kg/day.