Tecentriq Uniunea Europeană - letonă - EMA (European Medicines Agency)

tecentriq

roche registration gmbh - atezolizumabs - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastiski līdzekļi - 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 kā monotherapy ir norādīts ārstēšanai pieaugušiem pacientiem ar lokāli papildu vai metastātiska nsclc pēc iepriekšējas ķīmijterapijas. 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 kā monotherapy ir norādīts ārstēšanai pieaugušiem pacientiem ar lokāli papildu vai metastātiska nsclc pēc iepriekšējas ķīmijterapijas. 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.

Lynparza Uniunea Europeană - letonă - EMA (European Medicines Agency)

lynparza

astrazeneca ab - olaparibs - olnīcu jaunveidojumi - antineoplastiski līdzekļi - olnīcu cancerlynparza ir norādīts kā monotherapy par:apkope ārstēšanai pieaugušiem pacientiem ar progresējošu (figo posmos, iii un iv) brca1/2-mutācijas (dzimumšūnas līnijas un/vai somatisko) augstas kvalitātes epitēlija olnīcu, olvados, vai primāro peritoneālās vēzi, kas ir atbildes reakcija (pilnīgu vai daļēju) pēc pirmās līnijas platīna ķīmijterapiju. 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 un 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. pacientiem ir jābūt iepriekš apstrādāts ar anthracycline un taxane gadā (neo)palīgvielu vai metastātiska iestatījumu, ja vien pacientiem nebija piemēroti šiem apstrādes veidiem (skatīt 5. iedaļu. pacientiem ar hormonu receptoru (ap)-pozitīvs krūts vēzis ir arī ir bijuši par to, vai pēc iepriekšējas endokrīnās terapijas, vai būt nepiemērota par endokrīnās terapijas. 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.

Perjeta Uniunea Europeană - letonă - EMA (European Medicines Agency)

perjeta

roche registration gmbh  - pertuzumab - krūts audzējs - antineoplastic agents, monoclonal antibodies - metastātisku krūts vēzi:perjeta ir norādīts lietošanai kopā ar trastuzumab un docetaxel pieaugušo pacientiem ar her2 pozitīvu metastātisku vai lokāli recidivējošu unresectable krūts vēzi, kuri nav saņēmuši iepriekšējās anti-her2 terapiju vai ķīmijterapiju to metastātiska slimība. neoadjuvant attieksmi pret krūts vēzi:perjeta ir norādīts lietošanai kopā ar trastuzumab un ķīmijterapiju, lai neoadjuvant ārstēšanai pieaugušiem pacientiem ar her2 pozitīvu, lokāli uzlabotas, pretiekaisuma, vai agrīno stadiju krūts vēža augsts risks atkārtoties.

Phesgo Uniunea Europeană - letonă - EMA (European Medicines Agency)

phesgo

roche registration gmbh - pertuzumab, trastuzumab - krūts audzējs - antineoplastiski līdzekļi - 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.

Daklinza Uniunea Europeană - letonă - EMA (European Medicines Agency)

daklinza

bristol-myers squibb pharma eeig - daklatasvir dihidrohlorīds - c hepatīts, hronisks - pretvīrusu līdzekļi sistēmiskai lietošanai - daklinza indicēts kombinācijā ar citām zālēm pieaugušo hroniskā c hepatīta vīrusa (hcv) infekcijas ārstēšanai (skatīt apakšpunktus 4. 2, 4. 4 un 5. hcv genotipa konkrētu darbību, skatīt 4. 4 un 5.

Evista Uniunea Europeană - letonă - EMA (European Medicines Agency)

evista

substipharm - cenas hidrohlorīds - osteoporoze, pēcmenopauzes - dzimumhormoni un dzimumsistēmas modulatori dzimumorgānu sistēma, - evista ir indicēts osteoporozes ārstēšanai un profilaksei sievietēm pēc menopauzes. būtiski samazināt saslimstību vertebral, bet ne gūžas lūzumu pierādīts. when determining the choice of evista or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

Viraferon Uniunea Europeană - letonă - EMA (European Medicines Agency)

viraferon

schering-plough europe - interferon alfa-2b - hepatitis c, chronic; hepatitis b, chronic - imunitātes stimulatori, - hronisks b hepatīts: Ārstēšana pieaugušiem pacientiem ar hronisku b hepatītu, kas saistīti ar pierādījumu par b hepatīta vīrusu replikācijas (klātbūtne hbv-dns un hbeag), paaugstināts alanīna aminotransferase (alt) un histoloģiski pierādīta aktīvās aknu iekaisumu un/vai fibroze. hroniskais c hepatīts:pieaugušie pacienti:introna ir norādīts ārstēšanai pieaugušiem pacientiem ar hronisku c hepatītu, kam ir paaugstināts transaminases bez aknu decompensation un kas ir pozitīvi uz seruma hcv-rns vai anti-hcv (skatīt 4. iedaļu. labākais veids, kā izmantot introna šajā norāde ir kopā ar ribavirin. chidren un pusaudžiem:introna ir paredzēta lietošanai kombinācijā režīms ar ribavirin, ārstēšanai bērniem un pusaudžiem, 3 gadu vecumu un vecākiem, kuriem ir hronisks c hepatīts, kas agrāk nav ārstēti, bez aknu decompensation, un kas ir pozitīvi uz seruma hcv-rns. lēmumu, lai ārstētu būtu jāpieņem katrā gadījumā atsevišķi, ņemot vērā visus pierādījumus par slimības progresēšanu, piemēram, aknu iekaisumu un fibroze, kā arī zīlēšana faktori atbildi, hcv genotipa un vīrusu slodzes. paredzamo labumu no ārstēšanas, būtu jāizsver, drošības konstatējumiem, kas novērotas pediatrijas mācību priekšmetos klīniskos pētījumos (skatīt 4. 4, 4. 8 un 5.

Aclasta Uniunea Europeană - letonă - EMA (European Medicines Agency)

aclasta

sandoz pharmaceuticals d.d. - zoledronic acid - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - zāles kaulu slimību ārstēšanai - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture, including those with a recent low-trauma hip fracture. attieksmi pret osteoporozi, kas saistītas ar ilgtermiņa sistēmisko glikokortikoīdu terapija sievietēm pēc menopauzes un vīriešiem paaugstināts risks lūzums. Ārstēšana paget ir slimības ar kaulu.

Mesulid 100 mg tabletes Letonia - letonă - Zāļu valsts aģentūra

mesulid 100 mg tabletes

helsinn birex pharmaceutical ltd., ireland - nimesulīds - tablete - 100 mg

Elonva Uniunea Europeană - letonă - EMA (European Medicines Agency)

elonva

n.v. organon - corifollitropin alfa - reproductive techniques, assisted; ovulation induction; investigative techniques - dzimumhormoni un dzimumsistēmas modulatori dzimumorgānu sistēma, - controlled ovarian stimulation (cos) in combination with a gnrh antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (art) program. elonva is indicated for the treatment of adolescent males (14 to less than 18 years and older) with hypogonadotropic hypogonadism, in combination with human chorionic gonadotropin (hcg).