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

bristol-myers squibb australia pty ltd - ipilimumab, quantity: 213 mg - injection, concentrated - excipient ingredients: trometamol hydrochloride; sodium chloride; mannitol; pentetic acid; polysorbate 80; sodium hydroxide; hydrochloric acid; water for injections - melanoma,yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,yervoy, in combination with nivolumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. the approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. all analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,renal cell carcinoma (rcc),yervoy, in combination with nivolumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,non-small cell lung cancer (nsclc),yervoy, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (nsclc) with no egfr or alk genomic tumour aberrations.,malignant pleural mesothelioma (mpm),yervoy, in combination with nivolumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,oesophageal squamous cell carcinoma (oscc),yervoy in combination with nivolumab is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression greater than or equal to 1% as determined by a validated test.

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

bristol-myers squibb australia pty ltd - ipilimumab, quantity: 53.5 mg - injection, concentrated - excipient ingredients: trometamol hydrochloride; sodium chloride; mannitol; pentetic acid; polysorbate 80; sodium hydroxide; hydrochloric acid; water for injections - melanoma,yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,yervoy, in combination with nivolumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. the approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. all analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,renal cell carcinoma (rcc),yervoy, in combination with nivolumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,non-small cell lung cancer (nsclc),yervoy, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (nsclc) with no egfr or alk genomic tumour aberrations.,malignant pleural mesothelioma (mpm),yervoy, in combination with nivolumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,oesophageal squamous cell carcinoma (oscc),yervoy in combination with nivolumab is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression greater than or equal to 1% as determined by a validated test.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - pembrolizumab - concentrate for solution for infusion - pembrolizumab 25 mg/ml - pembrolizumab - melanoma• keytruda is indicated for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma.•keytruda is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage iib, iic, or iii melanoma following complete resection.non-small cell lung cancer• keytruda, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (nsclc) negative for egfr or alk genomic tumor aberrations.• keytruda, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound , is indicated for the first-line treatment of patients with metastatic squamous nsclc.• keytruda, as a single agent, is indicated for the treatment of patients with metastatic nsclc whose tumors express pd-l1 [tumor proportion score (tps) ≥50%)] as determined by a validated test. patients with egfr or alk genomic tumor aberrations should have disease progression on or after platinum-containing chemotherapy and an approved therapy for these aberrations prior to receiving keytruda .• keytruda, as a single agent, is indicated for the treatment of patients with advanced nsclc whose tumors express pd-l1 as determined by a validated test, with disease progression on or after platinum containing chemotherapy. patients with egfr or alk genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving keytruda .• keytruda , as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage ib (t2a ≥4 cm), ii, or iiia nsclc.head and neck cancer• keytruda, in combination with platinum and fluorouracil (fu), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (hnscc).• keytruda, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent hnscc whose tumors express pd-l1 [combined positive score (cps) ≥1] as determined by a validated test .• keytruda, as a single agent, is indicated for the treatment of patients with recurrent or metastatic hnscc with disease progression on or after platinum-containing chemotherapy..classical hodgkin lymphoma• keytruda is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma (chl).• keytruda is indicated for the treatment of pediatric patients with refractory chl, or chl that has relapsed after 2 or more lines of therapyprimary mediastinal large b-cell lymphoma keytruda is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large b-cell lymphoma (pmbcl), or who have relapsed after 2 or more prior lines of therapy.limitation of use: keytruda is not recommended for treatment of patients with pmbcl who require urgent cytoreductive therapy.urothelial carcinoma• keytruda is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express pd-l1 [combined positive score (cps ≥10) ] as determined by a validated test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of pd-l1 status. • keytruda is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.microsatellite instability-high cancerkeytruda is indicated for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (msi h) or mismatch repair deficient (dmmr). • solid tumors that have progressed following prior systemic treatment and who have no satisfactory alternative treatment options,or• colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.limitation of use: the safety and effectiveness of keytruda in pediatric patients with msi h central nervous system cancers have not been established. gastric cancer• keytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction (gej) adenocarcinoma in adults whose tumors express pd-l1 with a cps ≥ 1.• keytruda ,as a single agent, is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gej whose tumors express pd-l1 [combined positive score (cps) ≥1] as determined by a validated test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, her2/neu targeted therapy.cervical cancer• keytruda, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express pd-l1 (cps ≥1) as determined by a validated test. • keytruda, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express pd-l1 (cps ≥1) as determined by a validated test.biliary tract carcinomakeytruda, in combination with chemotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract carcinoma (btc).merkel cell carcinomakeytruda is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic merkel cell carcinoma (mcc).renal cell carcinoma• keytruda, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).• keytruda, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced rcc.• keytruda is indicated for the adjuvant treatment of patients with rcc at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.non-muscle invasive bladder cancer (nmibc)keytruda 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 tumors who are ineligible for or have elected not to undergo cystectomy.esophageal cancer• keytruda is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (gej) (siewert type i) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.• keytruda is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express pd-l1 (cps ≥10) as determined by a validated test, with disease progression after one or more prior lines of systemic therapy.cutaneous squamous cell carcinomakeytruda is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cscc) or locally advanced cscc that is not curable by surgery or radiationmicrosatellite instability-high or mismatch repair deficient colorectal cancer (crc)keytruda is indicated for the first-line treatment of patients with unresectable or metastatic msi-h or dmmr colorectal cancer (crc).tumor mutational burden-high cancerkeytruda is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (tmb-h) [≥10 mutations/megabase (mut/mb)] solid tumors, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.limitations of use: the safety and effectiveness of keytruda in pediatric patients with tmb-h central nervous system cancers have not been established.triple negative breast cancer• keytruda, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (tnbc) whose tumors express pd-l1 (cps ≥10) as determined by a validated test• keytruda 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 a single agent as adjuvant treatment after surgery.endometrial carcinomakeytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy and who are not candidates for curative surgery or radiation.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

melcann ltd - dicamba dimethylamine salt | mcpa dimethylamine salt - herbicide

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

melcann ltd - 2,2-dpa sodium salt | simazine | amitrole - herbicide

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

ac newco pty ltd - octocrylene, quantity: 85 mg/g; homosalate, quantity: 80 mg/g; bemotrizinol, quantity: 60 mg/g; butyl methoxydibenzoylmethane, quantity: 40 mg/g; titanium dioxide, quantity: 29.6 mg/g; methylene bis-benzotriazolyl tetramethylbutylphenol, quantity: 25 mg/g; polysilicone-15, quantity: 20 mg/g - cream - excipient ingredients: purified water; cyclomethicone; dibutyl adipate; ethanol; peg-30 dipolyhydroxystearate; styrene/acrylates copolymer; peg-12 dimeticone/ppg-20 crosspolymer; acrylates/acrylamide copolymer; bis-ethylhexyl hydroxydimethoxy benzylmalonate; phenoxyethanol; jojoba esters; iron oxide yellow; hexyl laurate; polyglyceryl-4 isostearate; sodium chloride; pvp/hexadecene copolymer; decyl glucoside; sunflower seed; disteardimonium hectorite; cetyl dimeticone; dimeticone 350; disodium edetate; ethylhexylglycerin; carnauba wax; polyglyceryl-3 diisostearate; hydrogenated lecithin; propylene glycol; xanthan gum; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; iron oxide red; iron oxide black; silicon dioxide; fragrance (perfume) - may assist in preventing some skin cancers (sunscreen) ; may reduce the risk of some skin cancers (sunscreen) ; spf 50 plus broad spectrum very high protection sunscreen ; can aid in the prevention of premature skin ageing (sunscreen) ; can aid in the prevention of solar keratosis (sunscreen) ; can aid in the prevention of sunspots (sunscreen)

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - azathioprine - film coated tablets - azathioprine 25 mg - azathioprine - azathioprine - immunosuppressive agent used in transplantation surgery for suppression of graft rejection. for special cases of rheumatoid arthritis- not responsive to other agents- and only by rheumatology experts in hospitals or rheumatic clinics.

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - azathioprine - film coated tablets - azathioprine 50 mg - azathioprine - azathioprine - immunosupressive agent used in transplantation surgery for suppression of graft rejection. for special cases of rheumatoid artritis, not responsive to other agents, and only by rheumatology experts in hospitals or rheumatic clinics.

Israel - English - Ministry of Health

novartis israel ltd - dabrafenib as mesilate - hard capsule - dabrafenib as mesilate 50 mg - dabrafenib - dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation.non-small cell lung cancer (nsclc) :dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.adjuvant treatment of melanoma :dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with braf v600 mutation, following complete resection.braf v600e mutation-positive locally advanced or metastatic anaplastic thyroid cancertafinlar is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment optionsbraf v600e mutation-positive unresectable or metastatic solid tumorstafinlar is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. limitations of use: dabrafenib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to braf inhibition. dabrafenib is indicated, in combination with trametinib, for the treatment of pediatric patients 6 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy

Israel - English - Ministry of Health

novartis israel ltd - dabrafenib as mesilate - hard capsule - dabrafenib as mesilate 50 mg - dabrafenib - dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation.non-small cell lung cancer (nsclc) :dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.adjuvant treatment of melanoma : dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with braf v600 mutation, following complete resection.braf v600e mutation-positive locally advanced or metastatic anaplastic thyroid cancertafinlar is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment options