Herceptin Europska Unija - hrvatski - EMA (European Medicines Agency)

herceptin

roche registration gmbh - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastična sredstva - grudi cancermetastatic grudi cancerherceptin indiciran za liječenje bolesnika s her2 pozitivnim metastaze raka dojke:u monoterapiji za liječenje pacijenata koji su primili najmanje dva načina kemoterapije za метастатической bolesti. prije kemoterapije moraju biti uključena barem антрациклина i таксана, ako pacijenti nisu prikladni za tih postupaka. hormon-receptor-pozitivnih bolesnika također mora biti hormonske terapije, ako pacijenti nisu prikladni za takav tretman, u kombinaciji s паклитакселом za liječenje onih pacijenata koji nisu primili kemoterapiju za метастатической bolesti i za koga антрациклиновый ne odgovara;u kombinaciju sa docetaxel za liječenje bolesnika koji nisu primali kemoterapiju za метастатической bolesti;u kombinaciji s inhibitor aromataze za liječenje pacijenata u postmenopauzi s hormon-receptor pozitivnim metastaze raka dojke, ne ranije liječenih трастузумаб. rano majčino cancerherceptin indiciran za liječenje bolesnika s her2 pozitivnim rani rak dojke:nakon operacije, kemoterapije (неоадъювантной ili adjuvantne) i radioterapije (ako je primjenjivo);nakon adjuvantne kemoterapije doksorubicin i ciklofosfamid, u kombinaciji s паклитакселом ili docetaxel, u kombinaciji s adjuvantne kemoterapije, koji se sastoji od доцетаксела i карбоплатина;u kombinaciji s неоадъювантной kemoterapije, nakon čega slijedi adjuvantne terapije Герцептин, za lokalno-popularnog (uključujući i upalne bolesti ili tumora >2 cm u promjeru. Герцептин treba koristiti samo u bolesnika s metastaze ili ranog raka dojke, tumora kojih je bilo her2 i гиперэкспрессии ili амплификации gena her2, kako se određuje točan i dokazani анализами. Метастатические cancerherceptin želuca u kombinaciji s Капецитабин ili 5-fluorouracil i cisplatine indiciran za liječenje bolesnika s her2 pozitivnog метастатического raka želuca ili пищеводно-želučani tranzicije, koji nisu primili do antitumorski lijek метастатической bolesti. Герцептин treba koristiti samo u bolesnika s metastaze raka želuca, bolesti koje imaju гиперэкспрессию her2 i kako se određuje ihc2+ i prateću СИШ ili rezultat ribom, ili ihc3+ rezultat. treba koristiti točne i dokazane metode analize .

Phesgo Europska Unija - hrvatski - EMA (European Medicines Agency)

phesgo

roche registration gmbh - pertuzumab, trastuzumab - neoplazme dojki - antineoplastična sredstva - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

PHESGO 600 mg/10 mL+ 600 mg/10 mL otopina za injekciju Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

phesgo 600 mg/10 ml+ 600 mg/10 ml otopina za injekciju

roche d.o.o.roche ltd. - pertuzumab, trastuzumab - otopina za injekciju - 600 mg/10 ml+ 600 mg/10 ml - 1 bočica sa 10 ml otopine za injekciju sadrži: 600 mg pertuzumaba 600 mg trastuzumaba

PHESGO 1200 mg/15 mL+ 600 mg/15 mL otopina za injekciju Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

phesgo 1200 mg/15 ml+ 600 mg/15 ml otopina za injekciju

roche d.o.o.roche ltd. - pertuzumab, trastuzumab - otopina za injekciju - 1200 mg/15 ml+ 600 mg/15 ml - 1 bočica sa 15 ml otopine za injekciju sadrži: 1200 mg pertuzumaba 600 mg trastuzumaba

Tukysa Europska Unija - hrvatski - EMA (European Medicines Agency)

tukysa

seagen b.v. - tucatinib - breast neoplasms; neoplasm metastasis - antineoplastična sredstva - tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with her2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑her2 treatment regimens.

Keytruda Europska Unija - hrvatski - EMA (European Medicines Agency)

keytruda

merck sharp & dohme b.v. - Пембролизумаб - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastična sredstva - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pacijenata sa egfr ili ala pozitivnih tumora mutacije također treba primili таргетную terapiju prije dobivanja Кейтруда. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, 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 in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, 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 adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Perjeta Europska Unija - hrvatski - EMA (European Medicines Agency)

perjeta

roche registration gmbh  - пертузумаб - neoplazme dojki - antineoplastic agents, monoclonal antibodies - Метастатический rak dojke:perjeta indiciran za primjenu u kombinaciji s трастузумабом i docetaxel u odraslih bolesnika s her2 pozitivnim metastaze ili lokalno-najčešći нерезектабельным raka dojke, koji nisu primili prethodne anti-her2 terapije ili kemoterapije za метастатической bolesti. Неоадъювантного liječenje raka dojke perjeta indiciran za primjenu u kombinaciji s трастузумабом i kemoterapije za неоадъювантного liječenje odraslih bolesnika s her2 pozitivnim, lokalno, upalne ili ranog raka dojke s visokim rizikom od recidiva.