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

astrazeneca pty ltd - osimertinib mesilate, quantity: 47.7 mg (equivalent: osimertinib, qty 40 mg) - tablet, film coated - excipient ingredients: purified talc; polyvinyl alcohol; hyprolose; iron oxide black; mannitol; titanium dioxide; macrogol 3350; sodium stearylfumarate; iron oxide red; iron oxide yellow; microcrystalline cellulose; purified water - tagrisso is indicated:,? as adjuvant therapy after tumour resection in patients with non-small cell lung cancer (nsclc) whose tumours have activating epidermal growth factor receptor (egfr) mutations, as detected by a validated test.,? for the first-line treatment of patients with locally advanced or metastatic nsclc whose tumours have activating egfr mutations, as detected by a validated test.,? for the treatment of patients with locally advanced or metastatic nsclc that is egfr t790m mutation-positive, as detected by a validated test.

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

astrazeneca pty ltd - osimertinib mesilate, quantity: 95.4 mg (equivalent: osimertinib, qty 80 mg) - tablet, film coated - excipient ingredients: iron oxide black; sodium stearylfumarate; polyvinyl alcohol; purified talc; titanium dioxide; iron oxide red; macrogol 3350; mannitol; hyprolose; iron oxide yellow; microcrystalline cellulose - tagrisso is indicated:,? as adjuvant therapy after tumour resection in patients with non-small cell lung cancer (nsclc) whose tumours have activating epidermal growth factor receptor (egfr) mutations, as detected by a validated test.,? for the first-line treatment of patients with locally advanced or metastatic nsclc whose tumours have activating egfr mutations, as detected by a validated test.,? for the treatment of patients with locally advanced or metastatic nsclc that is egfr t790m mutation-positive, as detected by a validated test.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - osimertinib mesilate 47.7mg equivalent to osimertinib 40mg;   - film coated tablet - 40 mg - active: osimertinib mesilate 47.7mg equivalent to osimertinib 40mg   excipient: hyprolose iron oxide black iron oxide red iron oxide yellow macrogol 3350 mannitol microcrystalline cellulose polyvinyl alcohol purified talc sodium stearyl fumarate titanium dioxide - tagrisso (osimertinib) as monotherapy is indicated for: - the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive non-small cell lung cancer. - the adjuvant treatment after tumour resection in adult patients with non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) mutations. tagrisso (osimertinib) is indicated in combination with: - pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic nsclc whose tumours have egfr mutations

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - osimertinib mesilate 95.4mg equivalent to osimertinib 80 mg;   - film coated tablet - 80 mg - active: osimertinib mesilate 95.4mg equivalent to osimertinib 80 mg   excipient: hyprolose iron oxide black iron oxide red iron oxide yellow macrogol 3350 mannitol microcrystalline cellulose polyvinyl alcohol purified talc sodium stearyl fumarate titanium dioxide - tagrisso (osimertinib) as monotherapy is indicated for: - the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive non-small cell lung cancer. - the adjuvant treatment after tumour resection in adult patients with non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) mutations. tagrisso (osimertinib) is indicated in combination with: - pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic nsclc whose tumours have egfr mutations

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - carcinoma, non-small-cell lung - other antineoplastic agents, protein kinase inhibitors - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations.- the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations.- the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations.- the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

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

astrazeneca pharmaceuticals lp - osimertinib (unii: 3c06jj0z2o) (osimertinib - unii:3c06jj0z2o) - osimertinib 40 - tagrisso is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (nsclc) whose tumors have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 l858r mutations, as detected by an fda-approved test [see dosage and administration (2.2) ] . tagrisso is indicated for the first-line treatment of adult patients with metastatic nsclc whose tumors have egfr exon 19 deletions or exon 21 l858r mutations, as detected by an fda-approved test [see dosage and administration (2.2) ] . tagrisso in combination with pemetrexed and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with locally advanced or metastatic nsclc whose tumors have egfr exon 19 deletions or exon 21 l858r mutations, as detected by an fda-approved test [see dosage and administration (2.2)]. tagrisso is indicated for the treatment of adult patients with metastatic egfr t790m mutation-positive nsclc, as detected by an fda-approved test, whose disease has progressed on or after egfr tyrosine kinase inhibitor (tki) therapy [see dosage and administration (2.2) ] . none. risk summary based on data from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , tagrisso can cause fetal harm when administered to a pregnant woman. there are no available data on tagrisso use in pregnant women. administration of osimertinib to pregnant rats was associated with embryolethality and reduced fetal growth at plasma exposures 1.5 times the exposure at the recommended clinical dose (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data when administered to pregnant rats prior to embryonic implantation through the end of organogenesis (gestation days 2-20) at a dose of 20 mg/kg/day, which produced plasma exposures of approximately 1.5 times the clinical exposure, osimertinib caused post-implantation loss and early embryonic death. when administered to pregnant rats from implantation through the closure of the hard palate (gestation days 6 to 16) at doses of 1 mg/kg/day and above (0.1 times the auc observed at the recommended clinical dose of 80 mg once daily), an equivocal increase in the rate of fetal malformations and variations was observed in treated litters relative to those of concurrent controls. when administered to pregnant dams at doses of 30 mg/kg/day during organogenesis through lactation day 6, osimertinib caused an increase in total litter loss and postnatal death. at a dose of 20 mg/kg/day, osimertinib administration during the same period resulted in increased postnatal death as well as a slight reduction in mean pup weight at birth that increased in magnitude between lactation days 4 and 6. risk summary there are no data on the presence of osimertinib or its active metabolites in human milk, the effects of osimertinib on the breastfed infant or on milk production. administration to rats during gestation and early lactation was associated with adverse effects, including reduced growth rates and neonatal death [see use in specific populations (8.1)] . because of the potential for serious adverse reactions in breastfed infants from osimertinib, advise women not to breastfeed during treatment with tagrisso and for 2 weeks after the final dose. based on animal data, tagrisso can cause malformations, embryo lethality, and postnatal death at doses resulting in exposures 1.5 times or less the human exposure at the clinical dose of 80 mg daily [see use in specific populations (8.1)]. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating tagrisso. contraception females advise females of reproductive potential to use effective contraception during treatment with tagrisso and for 6 weeks after the final dose [see use in specific populations (8.1)] . males advise male patients with female partners of reproductive potential to use effective contraception during and for 4 months following the final dose of tagrisso [see nonclinical toxicology (13.1)] . infertility based on animal studies, tagrisso may impair fertility in females and males of reproductive potential. the effects on female fertility showed a trend toward reversibility. it is not known whether the effects on male fertility are reversible [see nonclinical toxicology (13.1)] . the safety and effectiveness of tagrisso in pediatric patients have not been established. monotherapy of the 1813 patients with egfr exon 19 deletion or exon 21 l858r mutation-positive nsclc who were treated with tagrisso monotherapy, 770 patients were ≥65 years and 207 patients were ≥75 years of age [see adverse reactions (6.1)] . exploratory analysis suggests a higher incidence of grade 3 or higher adverse reactions (43% vs 33%) and more frequent dosage modifications for adverse reactions (34% vs 23%) in patients 65 years or older as compared to those younger than 65 years. no overall differences in safety or effectiveness were observed between patients 65 years or older and younger patients. tagrisso in combination with pemetrexed and platinum-based chemotherapy of the 276 patients with egfr exon 19 deletion or exon 21 l858r mutation-positive, locally advanced or metastatic nsclc treated with tagrisso in combination with pemetrexed and platinum-based chemotherapy, 104 patients were ≥65 years and 23 patients were ≥75 years of age [see adverse reactions (6.1)] . exploratory analysis suggests a higher incidence of grade 3 or higher adverse reactions (68% vs 61%) and more frequent dosage modifications for adverse reactions (55% vs 43%) in patients 65 years or older as compared to those younger than 65 years. clinical studies of tagrisso in combination with pemetrexed and platinum-based chemotherapy did not include sufficient numbers of patients age 65 and over to determine whether they respond differently from younger patients. no dose adjustment is recommended in patients with creatinine clearance (clcr) 15 - 89 ml/min, as estimated by cockcroft-gault. there is no recommended dose of tagrisso for patients with end-stage renal disease (clcr <15 ml/min) [see clinical pharmacology (12.3)]. no dose adjustment is recommended in patients with mild to moderate hepatic impairment (child-pugh a and b or total bilirubin ≤ uln and ast > uln or total bilirubin 1 to 3 times uln and any ast). there is no recommended dose for tagrisso for patients with severe hepatic impairment (total bilirubin between 3 to 10 times uln and any ast) [see clinical pharmacology (12.3)] .

Israel - English - Ministry of Health

astrazeneca (israel) ltd - osimertinib as mesylate - tablets - osimertinib as mesylate 40 mg - osimertinib - tagrisso as monotherapy is indicated for: • the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) mutations. • the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (nsclc) whose tumors have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 l858r mutations.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - osimertinib as mesylate - tablets - osimertinib as mesylate 80 mg - osimertinib - tagrisso as monotherapy is indicated for: • the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) mutations. • the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclctagrisso is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (nsclc) whose tumors have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 l858r mutations.

Kenya - English - Pharmacy and Poisons Board

osimertinib mesylate inn equivalent to osimertinib - tablet - each film coated tablet contains: osimertinib… - osimertinib

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

astrazeneca, sweden - osimertinib mesilate - film-coated tablet - 40 mg