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

roche products pty ltd - pralsetinib, quantity: 100 mg - capsule, hard - excipient ingredients: sodium bicarbonate; microcrystalline cellulose; magnesium stearate; citric acid; pregelatinised starch; hypromellose; titanium dioxide; brilliant blue fcf; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - non-small cell lung cancer (nsclc),gavreto has provisional approval in australia for the treatment of adult patients with locally advanced or metastatic rearranged during transfection (ret) fusion-positive non-small cell lung cancer (nsclc). the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor) in single-arm trials. continued approval of this indication depends on verification and description of benefit in confirmatory trials. ret-fusion positive thyroid cancer,gavreto has provisional approval in australia for the treatment of adult patients with advanced or metastatic ret-fusion positive thyroid cancer that is refractory to (or unsuitable for) radioactive iodine and who have progressed on or are unable to tolerate lenvatinib or sorafenib. the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor). continued approval of this indication depends on verification and description of benefit in confirmatory trials.

Israel - englanti - Ministry of Health

roche pharmaceuticals (israel) ltd - pralsetinib - hard capsule - pralsetinib 100 mg - pralsetinib - - gavreto is indicated for the treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer (nsclc).- gavreto is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (mtc) who require systemic therapy.- gavreto is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Yhdysvallat - englanti - NLM (National Library of Medicine)

blueprint medicines corporation - pralsetinib (unii: 1wpe73o1wv) (pralsetinib - unii:1wpe73o1wv) - gavreto is indicated for the treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer (nsclc) as detected by an fda approved test. this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). gavreto is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret -mutant medullary thyroid cancer (mtc) who require systemic therapy. this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies (14.2)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). gavreto is indicated for the treatment of adult and pediatric patients 12 years of age and older wit

Yhdysvallat - englanti - NLM (National Library of Medicine)

genentech, inc. - pralsetinib (unii: 1wpe73o1wv) (pralsetinib - unii:1wpe73o1wv) - gavreto is indicated for the treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer (nsclc) as detected by an fda approved test. gavreto is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies (14.2)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. risk summary based on findings from animal studies and its mechanism of action, gavreto can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. there are no available data on gavreto use in pregnant women to inform drug-associated risk. oral administration of

Euroopan unioni - englanti - EMA (European Medicines Agency)

roche registration gmbh  - pralsetinib - carcinoma, non-small-cell lung - antineoplastic agents - gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (ret) fusion-positive advanced non-small cell lung cancer (nsclc) not previously treated with a ret inhibitor.

Kanada - englanti - Health Canada

hoffmann-la roche limited - pralsetinib - capsule - 100mg - pralsetinib 100mg - antineoplastic agents

Singapore - englanti - HSA (Health Sciences Authority)

roche singapore pte. ltd. - pralsetinib - capsule - pralsetinib 100.0mg

Filippiinit - englanti - FDA (Food And Drug Administration)

f. hoffmann - la roche ltd.; importer: roche (philippines), inc.; distributor: roche (philippines), inc. - pralsetinib - capsule - 100 mg

Etelä-Afrikka - englanti - South African Health Products Regulatory Authority (SAHPRA)

roche products (pty) ltd - capsules - 100,0 mg - each capsule contains prasetinib 100,0 mg

Israel - englanti - Ministry of Health

taro international ltd, israel - erlotinib as hydrochloride - film coated tablets - erlotinib as hydrochloride 100 mg - erlotinib - non-small cell lung cancer (nsclc): erlotinib taro is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations. erlotinib taro is indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations and stable disease after first-line chemotherapy. erlotinib taro is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.pancreatic cancer: erlotinib taro is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.