Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

boehringer ingelheim (malaysia) sdn. bhd. - afatinib dimaleate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

boehringer ingelheim (malaysia) sdn. bhd. - afatinib dimaleate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

boehringer ingelheim (malaysia) sdn. bhd. - afatinib dimaleate -

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

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - afatinib as dimaleate - film coated tablets - afatinib as dimaleate 20 mg - afatinib - giotrif as monotherapy is indicated for the treatment of: • egfr tki-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutation(s);• locally advanced or metastatic nsclc of squamous histology progressing on or after platinum-based chemotherapy.

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - afatinib as dimaleate - film coated tablets - afatinib as dimaleate 30 mg - afatinib - giotrif as monotherapy is indicated for the treatment of: • egfr tki-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutation(s);• locally advanced or metastatic nsclc of squamous histology progressing on or after platinum-based chemotherapy.

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - afatinib as dimaleate - film coated tablets - afatinib as dimaleate 40 mg - afatinib - giotrif as monotherapy is indicated for the treatment of: • egfr tki-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutation(s);• locally advanced or metastatic nsclc of squamous histology progressing on or after platinum-based chemotherapy.

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - afatinib as dimaleate - film coated tablets - afatinib as dimaleate 50 mg - afatinib - giotrif as monotherapy is indicated for the treatment of: • egfr tki-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutation(s);• locally advanced or metastatic nsclc of squamous histology progressing on or after platinum-based chemotherapy.

Kenya - English - Pharmacy and Poisons Board

beacon medicare limited 9/b/2, toyenbee circular road, motijheel, - afatinib - tablet - afatinib 40mg - afatinib

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - afatinib - carcinoma, non-small-cell lung - antineoplastic agents - giotrif as monotherapy is indicated for the treatment ofepidermal growth factor receptor (egfr) tki-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutation(s);locally advanced or metastatic nsclc of squamous histology progressing on or after platinum-based chemotherapy.