Erlotinib Tablets BP 150mg Technical Specification:

Product Name:Erlotinib Tablets BP 150mg
Brand Name:Generics
Strength:25mg, 100mg, 150mg
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: Erlotinib is a type of targeted cancer drug. It is a treatment for non-small cell lung cancer (NSCLC) that has spread and for advanced pancreatic cancer
Storage:Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Erlotinib Tablets BP 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Erlotinib Tablets BP 150mg
    Each film-coated tablet contains:
    Erlotinib Hydrochloride BP Equivalent to
    Erlotinib.………………………………….150mg
    Excipients………………………………… q.s.
    Colours: Iron Oxide Yellow

THERAPEUTIC INDICATIONS:

Erlotinib is a type of targeted cancer drug. It is a treatment for non-small cell lung cancer (NSCLC) that has spread and for advanced pancreatic cancer

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.

Dispense in a tight, light resistant containers as defined in the USP.

Keep out of reach and sight of children.

Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Erlotinib Tablets BP 25mg
b) Erlotinib Tablets BP 100mg
c) Erlotinib Tablets BP 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Erlotinib Tablets BP 25mg
Each film-coated tablet contains:
Erlotinib Hydrochloride BP Equivalent to
Erlotinib.………………………………….25mg
Excipients………………………………… q.s.
Colours: Titanium Dioxide BP

b) Erlotinib Tablets BP 100mg
Each film-coated tablet contains:
Erlotinib Hydrochloride BP Equivalent to
Erlotinib.………………………………….100mg
Excipients………………………………… q.s.
Colours: Iron Oxide Red

c) Erlotinib Tablets BP 150mg
Each film-coated tablet contains:
Erlotinib Hydrochloride BP Equivalent to
Erlotinib.………………………………….150mg
Excipients………………………………… q.s.
Colours: Iron Oxide Yellow


THERAPEUTIC INDICATIONS:

Erlotinib is a type of targeted cancer drug. It is a treatment for non-small cell lung cancer (NSCLC) that has spread and for advanced pancreatic cancer

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.
Dispense in a tight, light resistant containers as defined in the USP.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.