Singapūra - angļu - HSA (Health Sciences Authority)

roche singapore pte. ltd. - erlotinib hydrochloride eqv. erlotinib - tablet, film coated - 100mg - erlotinib hydrochloride eqv. erlotinib 100mg

Singapūra - angļu - HSA (Health Sciences Authority)

roche singapore pte. ltd. - erlotinib hydrochloride 163.93 mg eqv erlotinib - tablet, film coated - 150 mg - erlotinib hydrochloride 163.93 mg eqv erlotinib 150 mg

Singapūra - angļu - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - gefitinib - tablet, film coated - 250 mg - gefitinib 250 mg

Singapūra - angļu - HSA (Health Sciences Authority)

pfizer private limited - dacomitinib monohydrate eqv dacomitinib - tablet, film coated - dacomitinib monohydrate eqv dacomitinib 15 mg

Singapūra - angļu - HSA (Health Sciences Authority)

pfizer private limited - dacomitinib monohydrate eqv dacomitinib - tablet, film coated - dacomitinib monohydrate eqv dacomitinib 30 mg

Singapūra - angļu - HSA (Health Sciences Authority)

pfizer private limited - dacomitinib monohydrate eqv dacomitinib - tablet, film coated - dacomitinib monohydrate eqv dacomitinib 45 mg

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - pembrolizumab, quantity: 100 mg - injection, concentrated - excipient ingredients: histidine; sucrose; water for injections; polysorbate 80; histidine hydrochloride monohydrate - melanoma,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of unresectable or metastatic melanoma in adults.,keytruda? (pembrolizumab) is indicated for the adjuvant treatment of adult and adolescent (12 years and older) patients with stage iib, iic, or iii melanoma who have undergone complete resection.,non-small cell lung cancer (nsclc),,keytruda? (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic non-squamous nsclc, with no egfr or alk genomic tumour aberrations.,keytruda? (pembrolizumab), in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of patients with metastatic squamous nsclc.,keytruda? (pembrolizumab) is indicated as monotherapy for the first-line treatment of patients with nsclc expressing pd-l1 [tumour proportion score (tps) greater than or equal 1%] as determined by a validated test, with no egfr or alk genomic tumour aberrations, and is,,? stage iii where patients are not candidates for surgical resection or definitive chemoradiation, or,,? metastatic.,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of patients with advanced nsclc whose tumours express pd-l1 with a greater than or equal 1% tps as determined by a validated test and who have received platinum-containing chemotherapy. patients with egfr or alk genomic tumour aberrations should have received prior therapy for these aberrations prior to receiving keytruda.,keytruda? (pembrolizumab) is indicated as monotherapy for the adjuvant treatment of patients with stage ib (t2a greater than or equal 4 cm), ii, or iiia nsclc who have undergone complete resection and platinum-based chemotherapy.,head and neck squamous cell cancer (hnscc),,keytruda? (pembrolizumab), as monotherapy or in combination with platinum and 5-fluorouracil (5-fu) chemotherapy, is indicated for the first-line treatment of patients with metastatic or unresectable recurrent hnscc, and whose tumours express pd-l1 [combined positive score (cps) greater than or equal 1] as determined by a validated test.,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of patients with metastatic or unresectable recurrent hnscc with disease progression on or after platinum-containing chemotherapy and whose tumours express pd-l1 [combined positive score (cps) greater than or equal 1] as determined by a validated test.,classical hodgkin lymphoma (chl),keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of adult and paediatric patients with relapsed or refractory classical hodgkin lymphoma (chl):,1. following autologous stem cell transplant (asct) or,,2. following at least two prior therapies when asct or multi-agent chemotherapy is not a treatment option.,the approval of this indication in paediatric patients is on the basis of objective response rate from patients aged 11 years and older from single arm trial data and extrapolation from adult data (see section 5.1 pharmacodynamic properties, clinical trials).,primary mediastinal b-cell lymphoma (pmbcl),,keytruda? (pembrolizumab) is indicated for the treatment of adult and paediatric patients with refractory primary mediastinal b-cell lymphoma (pmbcl), or who have relapsed after 2 or more prior lines of therapy. the approval of this indication is on the basis of objective response rate (orr) and duration of response from non-randomised studies. see section 5.1 pharmacodynamic properties, clinical trials.,urothelial carcinoma,,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy. this indication is approved based on overall response rate and duration of response in a single-arm study. improvements in overall survival, progression-free survival, or health-related quality of life have not been established.,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have received platinum-containing chemotherapy.,endometrial carcinoma,,keytruda? (pembrolizumab), in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is not msi-h or dmmr, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.,cervical cancer,keytruda? (pembrolizumab) in combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express pd-l1 [combined positive score (cps) greater than or equal 1] as determined by a validated test.,renal cell carcinoma (rcc),keytruda? (pembrolizumab), in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (rcc).,keytruda? in combination with lenvima? (lenvatinib) is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).,keytruda? (pembrolizumab), as monotherapy, is indicated for the adjuvant treatment of patients with rcc with a clear cell component who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (see section 5.1, clinical trials: renal cell carcinoma).,oesophageal cancer,keytruda? (pembrolizumab), in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with locally advanced or metastatic carcinoma of the oesophagus or her2 negative gastroesophageal junction adenocarcinoma (tumour centre 1 to 5 centimetres above the gastroesophageal junction) that is not amenable to surgical resection or definitive chemoradiation.,triple-negative breast cancer,keytruda? (pembrolizumab) is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (tnbc) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.,keytruda? (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic tnbc whose tumours express pd-l1 (cps greater than or equal 10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease. urothelial carcinoma,keytruda? (pembrolizumab) is indicated for the treatment of patients with bacillus calmette-guerin (bcg)-unresponsive, high-risk, non-muscle invasive bladder cancer (nmibc) with carcinoma in-situ (cis) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.,this indication was approved via the provisional approval pathway based on complete response rate and duration of response. continued approval of this indication depends on verification and description of benefit in confirmatory trials.,cutaneous squamous cell carcinoma,,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cscc) or locally advanced cscc that is not curable by surgery or radiation.,this indication was approved via the provisional approval pathway based on objective response rate and duration of response from a single-arm study. improvements in overall survival, progression-free survival, or healthrelated quality of life have not been established. full registration for this indication depends on submission of further clinical data to confirm the clinical benefit of the medicine.,tumour mutational burden-high (tmb-h) cancer,keytruda? (pembrolizumab) is indicated for the treatment of adult and paediatric patients with unresectable or metastatic tumour mutational burden-high (tmb-h) [greater than or equal 10 mutations/megabase (mut/mb)] solid tumours, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.,this indication was approved via the provisional approval pathway, based on the pooling of data on objective response rate and response duration across multiple different tissue types in a single-arm trial. the assumption that tmb-h status is predictive of the treatment effect of keytruda for every tissue type has not been verified. full registration for this indication depends on verification and description of clinical benefit in confirmatory trials. microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) cancer,keytruda? (pembrolizumab) is indicated for the treatment of adult and paediatric patients with unresectable or metastatic solid tumours that are msi-h or dmmr, as determined by a validated test, that have progressed following prior treatment and when there are no satisfactory alternative treatment options.,microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) colorectal cancer,keytruda? (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic colorectal cancer (crc) that is msi-h or dmmr as determined by a validated test.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - atezolizumab, quantity: 840 mg - injection, concentrated - excipient ingredients: histidine; glacial acetic acid; polysorbate 20; sucrose; water for injections - early-stage non-small cell lung cancer,tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with stage ii to iiia (as per 7th edition of the uicc/ajcc staging system) nsclc whose tumours have pd-l1 expression on greater than or equal to 50% of tumour cells.,metastatic non-small cell lung cancer,tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.,tecentriq, in combination with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and carboplatin, is indicated for first-line treatment of patients with metastatic non-squamous nsclc who do not have tumour egfr or alk genomic aberrations.,tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic nsclc after prior chemotherapy. patients with egfr mutant or alk-positive nsclc should also have received targeted therapies before receiving tecentriq.,small cell lung cancer,tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (es-sclc).,urothelial carcinoma,tecentriq is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who,? are considered cisplatin ineligible and whose tumours express pd-l1 (pd-l1 stained tumour-infiltrating immune cells [ic] covering greater than or equal to 5% of the tumour area), as determined by a validated test, or,? are considered ineligible for any other platinum-containing chemotherapy regardless of the level of tumour pd-l1 expression.,this indication is approved based on overall response rate and duration of response in a single-arm study. improvements in overall survival, progression-free survival, or health-related quality of life have not been established.,hepatocellular carcinoma,tecentriq, in combination with bevacizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (hcc) who have not received prior systemic therapy.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

pierre fabre australia pty ltd - encorafenib, quantity: 75 mg - capsule, hard - excipient ingredients: magnesium stearate; copovidone; iron oxide black; gelatin; iron oxide red; iron oxide yellow; poloxamer; titanium dioxide; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; succinic acid - melanoma,encorafenib, in combination with binimetinib, is indicated for the treatment of adult patients who have unresectable or metastatic melanoma with a braf v600e or v600k mutation, as detected by a validated test.,colorectal cancer,encorafenib, in combination with cetuximab, is indicated for the treatment of adult patients who have metastatic colorectal cancer (mcrc) with a braf v600e mutation as detected by a validated test, and who have received prior systemic therapy.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

pierre fabre australia pty ltd - encorafenib, quantity: 50 mg - capsule, hard - excipient ingredients: magnesium stearate; copovidone; iron oxide black; gelatin; iron oxide red; iron oxide yellow; poloxamer; titanium dioxide; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; succinic acid - melanoma,encorafenib, in combination with binimetinib, is indicated for the treatment of adult patients who have unresectable or metastatic melanoma with a braf v600e or v600k mutation, as detected by a validated test.,colorectal cancer,encorafenib, in combination with cetuximab, is indicated for the treatment of adult patients who have metastatic colorectal cancer (mcrc) with a braf v600e mutation as detected by a validated test, and who have received prior systemic therapy.