Euroopa Liit - inglise - EMA (European Medicines Agency)

amgen europe bv - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastic agents - metastatic breast cancerkanjinti is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. hormone-receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive mbc, not previously treated with trastuzumab.early breast cancerkanjinti is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc):following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.in combination with neoadjuvant chemotherapy followed by adjuvant kanjinti therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.kanjinti should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.metastatic gastric cancerkanjinti in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.kanjinti should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc 2+ and a confirmatory sish or fish result, or by an ihc 3+ result. accurate and validated assay methods should be used.

Euroopa Liit - inglise - EMA (European Medicines Agency)

pfizer europe ma eeig - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastic agents - breast cancermetastatic breast cancertrazimera is indicated for the treatment of adult patients with her2 positive metastatic breast cancer: (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive mbc, not previously treated with trastuzumab.early breast cancertrazimera is indicated for the treatment of adult patients with her2 positive early breast cancer. (ebc).following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.in combination with neoadjuvant chemotherapy followed by adjuvant trazimera therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.trazimera should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.metastatic gastric cancertrazimera in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.trazimera should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. accurate and validated assay methods should be used.

Malta - inglise - Malta Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - sugammadex - solution for injection - sugammadex 200 mg - all other therapeutic products

Malta - inglise - Malta Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - sugammadex - solution for injection - sugammadex 500 mg - all other therapeutic products

Iisrael - inglise - Ministry of Health

dexcel ltd, israel - trastuzumab - powder and solvent for concentrate for solution for infusion - trastuzumab 420 mg/vial - trastuzumab - ogivri is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: 1. as a single agent for the treatment of those patients who have received one or more chemotherapy regiments for their metastatic disease. 2. in combination with paclitaxel or docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. 3. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer. early breast cancer (ebc) :ogivri is indicated to treat patients with her2-positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding anthracyclines. ogivri should only be used in patients whose tumors have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.her2 metastatic gastric cancer (mgc).ogivri in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.ogivri should only be used in patients with metastatic gastric cancer whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory fish+ result, or ihc 3+, as determined by an accurate and validated assay.

Euroopa Liit - inglise - EMA (European Medicines Agency)

accord healthcare s.l.u. - trastuzumab - breast neoplasms; stomach neoplasms - antineoplastic agents - breast cancermetastatic breast cancer zercepac is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.                     in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive mbc, not previously treated with trastuzumab.early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc).following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.in combination with neoadjuvant chemotherapy followed by adjuvant zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.metastatic gastric cancer zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.zercepac should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. accurate and validated assay methods should be used.

Iisrael - inglise - 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.

Euroopa Liit - inglise - EMA (European Medicines Agency)

intervet international b.v. - bluetongue virus vaccine, serotype 8 (inactivated) - immunologicals for ovidae - cattle; sheep - sheepfor the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.cattlefor the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8.*(cycling value (ct) ≥ 36 by a validated rt-pcr method, indicating no presence of viral genome)

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - olaparib, quantity: 150 mg - tablet, film coated - excipient ingredients: copovidone; colloidal anhydrous silica; mannitol; sodium stearylfumarate; hypromellose; macrogol 400; titanium dioxide; iron oxide yellow; iron oxide black - ovarian cancer,lynparza is indicated as monotherapy for the:,? maintenance treatment of adult patients who have advanced, high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer with a deleterious or suspected deleterious, breast cancer susceptibility gene (brca) mutation (germline or somatic), which is in response (complete or partial) to first-line platinum-based chemotherapy.,? maintenance treatment of adult patients who have platinum-sensitive relapsed, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer which is in response (complete or partial) after platinum-based chemotherapy. prior treatment must have included at least 2 courses of platinum-based regimens.,lynparza in combination with bevacizumab is indicated for the:,? maintenance treatment of adult patients who have advanced, epithelial ovarian, fallopian tube or primary peritoneal cancer which is in response (complete or partial) to first-line platinumbased chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd)-positive status defined by either:,- a deleterious or suspected deleterious brca mutation (germline or somatic), and/or,- genomic instability breast cancer,lynparza is indicated as monotherapy for the:,? treatment of adult patients with germline brca-mutated her2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. germline brca mutation (gbrcam) status should be determined by an experienced laboratory using a validated test method.,lynparza is indicated as monotherapy for the:,? adjuvant treatment of adult patients with brca-mutated her2-negative high risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 -dose and method of administration and 5.1 -pharmacodynamic properties). prostate cancer,lynparza is indicated as monotherapy for the:,? treatment of adult patients who have metastatic castration-resistant prostate cancer (mcrpc) with a deleterious or suspected deleterious brca mutation (germline or somatic), which has progressed following prior therapy that included a new hormonal agent.,lynparza in combination with abiraterone and either prednisone or prednisolone is indicated for the:,? treatment of adult patients who have mcrpc with a deleterious or suspected deleterious brca mutation (germline or somatic). adenocarcinoma of the pancreas,lynparza is indicated as monotherapy for the:,? maintenance treatment of adult patients who have metastatic pancreatic adenocarcinoma with a deleterious or suspected deleterious gbrcam, which has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - olaparib, quantity: 100 mg - tablet, film coated - excipient ingredients: copovidone; colloidal anhydrous silica; mannitol; sodium stearylfumarate; hypromellose; macrogol 400; titanium dioxide; iron oxide yellow - ovarian cancer,lynparza is indicated as monotherapy for the:,? maintenance treatment of adult patients with advanced breast cancer susceptibility gene (brca) mutated (germline or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. brca mutation status should be determined by an experienced laboratory using a validated test method.,? maintenance treatment of adult patients with platinum-sensitive relapsed high grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) after platinum-based chemotherapy. prior treatment must have included at least 2 courses of platinum-based regimens.,lynparza in combination with bevacizumab is indicated for the:,? maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd)-positive status defined by either: a deleterious or suspected deleterious brca mutation (germline or somatic), and/or; genomic instability,hrd status should be determined by an experienced laboratory using a validated test method. ovarian cancer,lynparza is indicated as monotherapy for the:,? maintenance treatment of adult patients who have advanced, high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer with a deleterious or suspected deleterious, breast cancer susceptibility gene (brca) mutation (germline or somatic), which is in response (complete or partial) to first-line platinum-based chemotherapy.,? maintenance treatment of adult patients who have platinum-sensitive relapsed, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer which is in response (complete or partial) after platinum-based chemotherapy. prior treatment must have included at least 2 courses of platinum-based regimens.,lynparza in combination with bevacizumab is indicated for the:,? maintenance treatment of adult patients who have advanced, epithelial ovarian, fallopian tube or primary peritoneal cancer which is in response (complete or partial) to first-line platinumbased chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd)-positive status defined by either:,- a deleterious or suspected deleterious brca mutation (germline or somatic), and/or,- genomic instability adenocarcinoma of the pancreas,lynparza is indicated as monotherapy for the:,? maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. germline brca mutation (gbrcam) status should be determined by an experienced laboratory using a validated test method. prostate cancer,lynparza is indicated as monotherapy for the:,? treatment of adult patients with brca-mutated (germline and/or somatic) metastatic castration-resistant prostate cancer who have progressed following prior therapy that included a new hormonal agent. brca mutation status should be determined by an experienced laboratory using a validated test method. breast cancer,lynparza is indicated as monotherapy for the:,? adjuvant treatment of adult patients who have her2-negative, high-risk early breast cancer with a deleterious or suspected deleterious germline brca mutation (gbrcam), for which they have previously been treated with neoadjuvant or adjuvant chemotherapy.,? treatment of adult patients who have her2-negative metastatic breast cancer with a deleterious or suspected deleterious gbrcam, for which they have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. prostate cancer,lynparza is indicated as monotherapy for the:,? treatment of adult patients who have metastatic castration-resistant prostate cancer (mcrpc) with a deleterious or suspected deleterious brca mutation (germline or somatic), which has progressed following prior therapy that included a new hormonal agent.,lynparza in combination with abiraterone and either prednisone or prednisolone is indicated for the:,? treatment of adult patients who have mcrpc with a deleterious or suspected deleterious brca mutation (germline or somatic). adenocarcinoma of the pancreas,lynparza is indicated as monotherapy for the:,? maintenance treatment of adult patients who have metastatic pancreatic adenocarcinoma with a deleterious or suspected deleterious gbrcam, which has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.