GENERIC NAME OF THE MEDICINAL PRODUCT:

Gefitinib Tablets 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Gefitinib Tablets 250mg
Each film-coated tablet contains:
Gefitinib…………………………250 mg
Excipients……………………….q.s.
Colours: Titanium Dioxide USP, Red Oxide of Iron, Yellow Oxide of Iron.

THERAPEUTIC INDICATIONS:

Gefitinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have certain types of abnormal epidermal growth factor (EGFR) genes.

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a cancer specialist only.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59° to 86° F).
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.

Gefitinib Tablets 250mg Technical Specification:

Product Name:Gefitinib Tablets 250mg
Brand Name:Gefitinib
Strength:250mg
Dosage Form:Film-coated Tablet
Packing:10s, 30s
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:Anti-Cancer
Indication: Gefitinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have certain types of abnormal epidermal growth factor (EGFR) genes.
Storage:Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Gefitinib Tablets 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Gefitinib Tablets 250mg
    Each film-coated tablet contains:
    Gefitinib…………………………250 mg
    Excipients……………………….q.s.
    Colours: Titanium Dioxide USP, Red Oxide of Iron, Yellow Oxide of Iron.

THERAPEUTIC INDICATIONS:

Gefitinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have certain types of abnormal epidermal growth factor (EGFR) genes.

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.

WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.

WARNING: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a cancer specialist only.

Keep out of reach and sight of children.

Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59° to 86° F).

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.