Kanada - enska - Health Canada

boehringer ingelheim (canada) ltd ltee - afatinib (afatinib dimaleate) - tablet - 40mg - afatinib (afatinib dimaleate) 40mg - antineoplastic agents

Bandaríkin - enska - 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

Singapúr - enska - 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

Singapúr - enska - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - afatinib dimaleate 44.3400mg eqv afatinib - tablet, film coated - 30.0000mg - afatinib dimaleate 44.3400mg eqv afatinib 30.0000mg

Singapúr - enska - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - afatinib dimaleate 59.1200mg eqv afatinib - tablet, film coated - 40.0000mg - afatinib dimaleate 59.1200mg eqv afatinib 40.0000mg

Singapúr - enska - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - afatinib dimaleate 73.9000mg eqv afatinib - tablet, film coated - 50.0000mg - afatinib dimaleate 73.9000mg eqv afatinib 50.0000mg

Bretland - enska - MHRA (Medicines & Healthcare Products Regulatory Agency)

boehringer ingelheim ltd - afatinib dimaleate - tablet - 20mg

Bretland - enska - MHRA (Medicines & Healthcare Products Regulatory Agency)

boehringer ingelheim ltd - afatinib dimaleate - tablet - 30mg

Bretland - enska - MHRA (Medicines & Healthcare Products Regulatory Agency)

boehringer ingelheim ltd - afatinib dimaleate - tablet - 40mg

Bretland - enska - MHRA (Medicines & Healthcare Products Regulatory Agency)

boehringer ingelheim ltd - afatinib dimaleate - tablet - 50mg