Uniunea Europeană - română - EMA (European Medicines Agency)

pinnacle biologics b.v.  - porfimer sodic - esofag barrett - agenți antineoplazici - terapia fotodinamică (tfd) cu photobarr este indicat pentru: ablatie displaziei de grad înalt (hgd) la pacienții cu esofag barrett (eb).

Uniunea Europeană - română - EMA (European Medicines Agency)

biofrontera bioscience gmbh - clorhidrat de acid 5-aminolevulinic - keratosis, actinic; carcinoma, basal cell - agenți antineoplazici - tratamentul keratozei actinice de severitate ușoară până la moderată, pe fata si scalp (olsen clasa a 1 a 2; a se vedea secțiunea 5. 1) și de câmp cancerization la adulți. tratamentul superficial și/sau carcinom bazocelular nodular nepotrivite pentru tratamentul chirurgical datorită posibil legate de tratament morbiditate și/sau săraci rezultatul cosmetic la adulți.

Uniunea Europeană - română - EMA (European Medicines Agency)

biolitec pharma ltd - temoporfină - head and neck neoplasms; carcinoma, squamous cell - agenți antineoplazici - foscan este indicat pentru tratamentul pacienţilor cu avansate capului si gatului cu celule scuamoase în lipsa prealabilă terapii paliative şi improprii de radioterapie, chirurgia sau chimioterapia sistemică.

Uniunea Europeană - română - EMA (European Medicines Agency)

photonamic gmbh & co. kg - clorhidrat de acid 5-aminolevulinic - gliom - agenți antineoplazici - gliolan este indicat la pacienţii adulţi pentru vizualizare de tesut malign in timpul interventiei chirurgicale pentru gliom malign (organizaţia mondială a sănătăţii grad iii si iv).

Uniunea Europeană - română - EMA (European Medicines Agency)

eli lilly nederland b.v. - olaratumab - sarcom - agenți antineoplazici - lartruvo este indicat în asociere cu doxorubicină pentru tratamentul pacienţilor adulţi cu sarcom avansate ţesuturilor moi care nu au cedat la tratamentul curativ cu interventii chirurgicale sau radioterapie şi care nu au fost tratate anterior cu doxorubicina (a se vedea sectiunea 5.

Uniunea Europeană - română - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - carcinom, pulmonar non-celulă mică - antineoplazice si imunomodulatoare, anticorpi monoclonali - nivolumab bms este indicat pentru tratamentul cancerului pulmonar cu celule mici nemetalopatii (nsclc) avansat la nivel local sau metastatic, dupa chimioterapia anterioara la adulti.

Uniunea Europeană - română - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - agenți antineoplazici - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. 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 (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq cum este indicat în monoterapie pentru tratamentul pacienților adulți cu nsclc local avansat sau metastatic după chimioterapie anterioară. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq cum este indicat în monoterapie pentru tratamentul pacienților adulți cu nsclc local avansat sau metastatic după chimioterapie anterioară. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Uniunea Europeană - română - EMA (European Medicines Agency)

steba biotech s.a - padeliporfin di-potasiu - prostate neoplasme - agenți antineoplazici - tookad este indicat ca monoterapie pentru pacienți adulți netratați anterior, unilaterală, cu risc scăzut, adenocarcinom de prostata cu o durata de viata minimum 10 ani și de:stadiul clinic t1c sau t2a;scor gleason ≤ 6, bazat pe înaltă rezoluție biopsie strategii;psa ≤ 10 ng/ml;3 pozitiv de cancer de nuclee cu o maximă de cancer de bază lungime de 5 mm în orice bază sau 1-2 pozitiv de cancer de nuclee cu ≥ 50 % de cancer de implicare în nici o bază sau un psa densitate ≥ 0. 15 ng/ml/cm3.

Uniunea Europeană - română - EMA (European Medicines Agency)

astrazeneca ab - durvalumab - carcinom, pulmonar non-celulă mică - agenți antineoplazici - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Uniunea Europeană - română - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - mogamulizumab - sezary syndrome; mycosis fungoides - agenți antineoplazici - poteligeo este indicat pentru tratamentul pacienților adulți cu mycosis fungoides (mf) sau sindromul sézary (ss) care au primit anterior cel puțin un tratament sistemic.