a) Favipiravir Tablets 200mg
b) Favipiravir Tablets 400mg
c) Favipiravir Tablets 800mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Favipiravir Tablets 200mg
Each film-coated tablet contains:
Favipiravir………………..……..200mg
Excipients………………………..q.s.
Colours: Titanium Dioxide
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
Each film-coated tablet contains:
Favipiravir………………..……..200mg
Excipients………………………..q.s.
Colours: Titanium Dioxide
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 Tablets is used 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 (Coronavirus).
DIRECTION OF USE:
As directed by the Physician
CAUTION & WARNING:
Warning: To be sold by retail on the prescription of Medical Specialist.
Warning: Do not administer the drug to women known or suspected to be pregnant
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
Warning: Do not administer the drug to women known or suspected to be pregnant
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 25°C. Protect from moisture.
Dosage: As directed by the Physician.
For Oral use. Read the package insert before use.
Dosage: As directed by the Physician.
For Oral use. Read the package insert before use.
Favipiravir Tablets Technical Specifications:
| Product Name: | Favipiravir Tablets |
| 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, COVID-19 |
| Indication: | Favipiravir is used 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 (Coronavirus). |
| Storage: | Store at a temperature not exceeding 25°C. Protect from moisture |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Favipiravir Tablets 200mg
- Favipiravir Tablets 400mg
- Favipiravir Tablets 800mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Favipiravir Tablets 200mg
Each film-coated tablet contains:
Favipiravir………………..……..200mg
Excipients………………………..q.s.
Colours: Titanium Dioxide
2. Favipiravir Tablets 400mg
Each film-coated tablet contains:
Favipiravir………………..……..400mg
Excipients………………………..q.s.
Colours: Red oxide of Iron
3. Favipiravir Tablets 800mg
Each film-coated tablet contains:
Favipiravir………………..……..800mg
Excipients………………………..q.s.
Colours: Yellow oxide of Iron
THERAPEUTIC INDICATIONS:
Favipiravir is used 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 (Coronavirus).
CAUTION & WARNING:
Warning: To be sold by retail on the prescription of Medical Specialist. 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.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 25°C. Protect from moisture.
Dosage: As directed by the Physician.
For Oral use. Read the package insert before use.
