Европейски съюз - немски - EMA (European Medicines Agency)

astrazeneca ab - olaparib - eierstock-neoplasmen - antineoplastische mittel - eierstock cancerlynparza ist angezeigt als monotherapie zur erhaltungstherapie von erwachsenen patienten mit fortgeschrittenem (figo-stadien iii und iv) brca1/2-mutierten (keimbahn und/oder somatisch) high-grade-epithelialen eierstockkrebs, eileiterkrebs oder primärem peritonealkarzinom, die in reaktion (vollständige oder teilweise) nach abschluss der first-line-chemotherapie auf platinbasis. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 und 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. sollten patienten, die zuvor behandelt wurden, mit einem anthrazyklin und einem taxan in der (neo)adjuvanten oder metastasierten setting, es sei denn, die patienten waren nicht geeignet für diese behandlung (siehe abschnitt 5. patienten mit hormon-rezeptor (hr)-positivem brustkrebs sollten auch fortgeschritten, die am oder nach vorheriger endokriner therapie, oder werden als ungeeignet für die endokrine therapie. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Европейски съюз - немски - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sonidegib-diphosphat - karzinom, basalzelle - antineoplastische mittel - odomzo ist zur behandlung von erwachsenen patienten mit lokal fortgeschrittenem basalzellkarzinom (bcc) indiziert, die keiner kurativen operation oder strahlentherapie zugänglich sind.

Европейски съюз - немски - EMA (European Medicines Agency)

medac gesellschaft fuer klinische spezialpraeparate mbh - asparaginase - vorläuferzelle lymphoblastische leukämie-lymphom - antineoplastische mittel - spectrila ist indiziert als ein bestandteil der antineoplastischen kombinationstherapie zur behandlung von akuter lymphoblastischer leukämie (all) bei pädiatrischen patienten von der geburt bis zum 18. lebensjahr und bei erwachsenen.

Швейцария - немски - Swissmedic (Swiss Agency for Therapeutic Products)

roche pharma (schweiz) ag - vismodegibum - kapseln - vismodegibum 150 mg, cellulosum microcristallinum, lactosum monohydricum 71.5 mg, natrii laurilsulfas, povidonum k 29-32, carboxymethylamylum natricum, talcum, magnesii stearas, kapselhülle: gelatina, e 171, e 172 (rubrum), e 172 (nigrum), drucktinte: lacca, e 172 (nigrum), excipiens pro capsula corresp. natrium 1.09 - 1.34 mg. - zytostatikum - synthetika

Швейцария - немски - Swissmedic (Swiss Agency for Therapeutic Products)

sun pharma switzerland ltd - sonidegibum - hartkapseln - sonidegibum 200 mg ut sonidegibi diphosphas, crospovidonum, lactosum monohydricum 38.60 mg, poloxamerum 188, natrii laurilsulfas corresp. natrium 0.605 mg, magnesii stearas, silica colloidalis anhydrica, kapselhülle: gelatina, e 171, e 172 (rubrum), drucktinte: lacca, e 172 (nigrum), propylenglycolum q.s., pro capsula. - basalzellkarzinom - synthetika

Швейцария - немски - Swissmedic (Swiss Agency for Therapeutic Products)

astrazeneca ag - olaparibum - kapseln - olaparibum 50 mg, macrogolglyceridorum laurates, kapselhülle: hypromellosum, e 171, gellani gummi, kalii acetas, drucktinte: lacca, e 172 (nigrum), pro capsula. - onkologikum - synthetika

Европейски съюз - немски - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastische mittel - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Швейцария - немски - Swissmedic (Swiss Agency for Therapeutic Products)

astrazeneca ag - olaparibum - filmtabletten - olaparibum 100 mg, copovidonum k 28, silica colloidalis anhydrica, mannitolum, natrii stearylis fumaras corresp. natrium 0.236 mg, Überzug: hypromellosum, macrogolum 400, e 171, e 172 (flavum), pro compresso obducto. - onkologikum - synthetika

Швейцария - немски - Swissmedic (Swiss Agency for Therapeutic Products)

astrazeneca ag - olaparibum - filmtabletten - olaparibum 150 mg, copovidonum k 28, silica colloidalis anhydrica, mannitolum, natrii stearylis fumaras corresp. natrium 0.354 mg, Überzug: hypromellosum, macrogolum 400, e 171, e 172 (flavum), e 172 (nigrum), pro compresso obducto. - onkologikum - synthetika

Европейски съюз - немски - EMA (European Medicines Agency)

pharmaand gmbh - rucaparib camsylate - eierstock-neoplasmen - antineoplastische mittel - rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. rubraca ist indiziert als monotherapie für die erhaltungstherapie von erwachsenen patientinnen mit platin-sensiblen rezidiv einer hochgradigen epithelialen eierstockkrebs, eileiterkrebs oder primärem peritonealkarzinom, die in reaktion (vollständige oder teilweise) auf platin-basierte chemotherapie.