Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - nintedanib esylate - capsule, soft - nintedanib

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - nintedanib esylate - capsule, soft - nintedanib

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

boehringer ingelheim pty ltd - nintedanib esilate, quantity: 180.6 mg (equivalent: nintedanib, qty 150 mg) - capsule, soft - excipient ingredients: iron oxide red; titanium dioxide; hard fat; lecithin; gelatin; glycerol; iron oxide yellow; medium chain triglycerides; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - ofev is indicated in combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer (nsclc) of adenocarcinoma tumour histology after failure of first line chemotherapy.,ofev is indicated for the treatment of idiopathic pulmonary fibrosis (ipf).,ofev is also indicated for the treatment of other chronic fibrosing interstitial lung diseases (ilds) with a progressive phenotype.,ofev is indicated for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (ssc-ild).

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

boehringer ingelheim pty ltd - nintedanib esilate, quantity: 120.4 mg (equivalent: nintedanib, qty 100 mg) - capsule, soft - excipient ingredients: hard fat; lecithin; glycerol; iron oxide red; gelatin; medium chain triglycerides; titanium dioxide; iron oxide yellow; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - ofev is indicated in combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer (nsclc) of adenocarcinoma tumour histology after failure of first line chemotherapy.,ofev is indicated for the treatment of idiopathic pulmonary fibrosis (ipf).,ofev is also indicated for the treatment of other chronic fibrosing interstitial lung diseases (ilds) with a progressive phenotype.,ofev is indicated for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (ssc-ild).

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

boehringer ingelheim pharmaceuticals, inc. - nintedanib esylate (unii: 42f62rtz4g) (nintedanib - unii:g6hrd2p839) - nintedanib 150 mg - ofev is indicated for the treatment of adults with idiopathic pulmonary fibrosis (ipf). ofev is indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ilds) with a progressive phenotype [see clinical studies (14.2)] . ofev is indicated to slow the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (ssc-ild). none risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , ofev can cause fetal harm when administered to a pregnant woman. there are no data on the use of ofev during pregnancy. in animal studies of pregnant rats and rabbits treated during organogenesis, nintedanib caused embryo-fetal deaths and structural abnormalities at less than (rats) and approximately 5 times (rabbits) the maximum recommended human dose [see data] . advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage

Malta - English - Medicines Authority

clonmel healthcare limited waterford road, clonmel, co. tipperary e91 d768, ireland - soft capsule - nintedanib 100 mg - antineoplastic agents

Malta - English - Medicines Authority

clonmel healthcare limited waterford road, clonmel, co. tipperary e91 d768, ireland - soft capsule - nintedanib 150 mg - antineoplastic agents

Malta - English - Medicines Authority

lotus pharma bulgaria eood 102d, cherni vrah blvd., fl. 6, sofia, 1470, , bulgaria - soft capsule - nintedanib 100 mg - antineoplastic agents

Malta - English - Medicines Authority

lotus pharma bulgaria eood 102d, cherni vrah blvd., fl. 6, sofia, 1470, , bulgaria - soft capsule - nintedanib 150 mg - antineoplastic agents

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

boehringer ingelheim pty ltd - nintedanib esilate, quantity: 120.4 mg (equivalent: nintedanib, qty 100 mg) - capsule, soft - excipient ingredients: lecithin; titanium dioxide; gelatin; iron oxide yellow; hard fat; medium chain triglycerides; iron oxide red; glycerol; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - vargatef is indicated in combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer (nsclc) of adenocarcinoma tumour histology after failure of first line chemotherapy.,vargatef is indicated for the treatment of idiopathic pulmonary fibrosis (ipf).,vargatef is also indicated for the treatment of other chronic fibrosing interstitial lung diseases (ilds) with a progressive phenotype.,vargatef is indicated for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (ssc-ild).