New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) limited - afatinib dimaleate 29.56mg equivalent to afatinib 20 mg - film coated tablet - 20 mg - active: afatinib dimaleate 29.56mg equivalent to afatinib 20 mg excipient: colloidal silicon dioxide crospovidone hypromellose lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose polysorbate 80 purified talc titanium dioxide - giotrif is indicated as monotherapy for the treatment of patients with: locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have epidermal growth factor receptor (egfr) mutations. locally advanced or metastatic non-small cell carcinoma of the lung of squamous histology progressing on or after platinum-based chemotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) limited - afatinib dimaleate 44.34mg equivalent to afatinib 30 mg - film coated tablet - 30 mg - active: afatinib dimaleate 44.34mg equivalent to afatinib 30 mg excipient: colloidal silicon dioxide crospovidone hypromellose indigo carmine aluminium lake lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose polysorbate 80 purified talc titanium dioxide - giotrif is indicated as monotherapy for the treatment of patients with: locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have epidermal growth factor receptor (egfr) mutations. locally advanced or metastatic non-small cell carcinoma of the lung of squamous histology progressing on or after platinum-based chemotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) limited - afatinib dimaleate 59.12mg equivalent to afatinib 40 mg - film coated tablet - 40 mg - active: afatinib dimaleate 59.12mg equivalent to afatinib 40 mg excipient: colloidal silicon dioxide crospovidone hypromellose indigo carmine aluminium lake lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose polysorbate 80 purified talc titanium dioxide - giotrif is indicated as monotherapy for the treatment of patients with: locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have epidermal growth factor receptor (egfr) mutations. locally advanced or metastatic non-small cell carcinoma of the lung of squamous histology progressing on or after platinum-based chemotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) limited - afatinib dimaleate 73.9mg equivalent to afatinib 50 mg - film coated tablet - 50 mg - active: afatinib dimaleate 73.9mg equivalent to afatinib 50 mg excipient: colloidal silicon dioxide crospovidone hypromellose indigo carmine aluminium lake lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose polysorbate 80 purified talc titanium dioxide - giotrif is indicated as monotherapy for the treatment of patients with: locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have epidermal growth factor receptor (egfr) mutations. locally advanced or metastatic non-small cell carcinoma of the lung of squamous histology progressing on or after platinum-based chemotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - afatinib dimaleate, quantity: 73.9 mg - tablet, film coated - excipient ingredients: purified talc; polysorbate 80; indigo carmine aluminium lake; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; macrogol 400; hypromellose; microcrystalline cellulose; titanium dioxide; crospovidone - giotrif is indicated as monotherapy for the treatment of adult patients with:,? locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have activating epidermal growth factor receptor (egfr) mutations.,? locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - afatinib dimaleate, quantity: 44.34 mg - tablet, film coated - excipient ingredients: crospovidone; titanium dioxide; polysorbate 80; lactose monohydrate; macrogol 400; colloidal anhydrous silica; microcrystalline cellulose; hypromellose; magnesium stearate; purified talc; indigo carmine aluminium lake - giotrif is indicated as monotherapy for the treatment of adult patients with:,? locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have activating epidermal growth factor receptor (egfr) mutations.,? locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - afatinib dimaleate, quantity: 59.12 mg - tablet, film coated - excipient ingredients: titanium dioxide; macrogol 400; purified talc; crospovidone; lactose monohydrate; hypromellose; microcrystalline cellulose; indigo carmine aluminium lake; colloidal anhydrous silica; polysorbate 80; magnesium stearate - giotrif is indicated as monotherapy for the treatment of adult patients with:,? locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have activating epidermal growth factor receptor (egfr) mutations.,? locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - afatinib dimaleate, quantity: 29.56 mg - tablet, film coated - excipient ingredients: lactose monohydrate; polysorbate 80; magnesium stearate; macrogol 400; titanium dioxide; crospovidone; microcrystalline cellulose; colloidal anhydrous silica; hypromellose; purified talc - giotrif is indicated as monotherapy for the treatment of adult patients with:,? locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have activating epidermal growth factor receptor (egfr) mutations.,? locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

United States - English - NLM (National Library of Medicine)

boehringer ingelheim pharmaceuticals, inc. - afatinib (unii: 41ud74l59m) (afatinib - unii:41ud74l59m) - afatinib 20 mg - gilotrif is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors have non-resistant epidermal growth factor receptor (egfr) mutations as detected by an fda-approved test [see dosage and administration (2.1), clinical pharmacology (12.1), clinical studies (14.1)]. limitations of use : the safety and efficacy of gilotrif have not been established in patients whose tumors have resistant egfr mutations [see clinical studies (14.1)]. gilotrif is indicated for the treatment of patients with metastatic squamous nsclc progressing after platinum-based chemotherapy. none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , gilotrif can cause fetal harm when administered to a pregnant woman. there are no available data on the use of gilotrif in pregnant women. administration of afatinib to pregnant rabbits during organogenesis at exposures approximately 0.2 times the exposure in humans at the rec

Singapore - English - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - afatinib dimaleate 29.5600mg eqv afatinib - tablet, film coated - 20.0000mg - afatinib dimaleate 29.5600mg eqv afatinib 20.0000mg