ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

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.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

teva b.v. - xinafoate сальметерол, flutikazon propionat - pulmonary disease, chronic obstructive; asthma - lijekovi za opstruktivne plućne bolesti dišnih putova, - spiromax aerivio indiciran za primjenu kod odraslih u dobi od 18 godina i stariji, samo. asthmaaerivio spiromax indiciran za redovito liječenje bolesnika s teškim oblikom astme, gdje je upotreba kombinacije proizvoda (inhalacijskim kortikosteroidima i trajno djeluju β2-agonista) odgovara:pacijentima nije dovoljno kontrolirani na manju snagu kortikosteroidne kombinirani lijek orpatients već prati na visoke doze inhalacijskim kortikosteroidima i trajno djeluju β2-agonista. kronične opstruktivne plućne bolesti (kopb)spiromax aerivio indiciran za simptomatsko liječenje bolesnika s kopb s ОФВ1.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - ciclesonide - dišnog sustava ostali lijekovi za opstruktivne plućne bolesti dišnih putova, inhalanata - konji - za smanjenje kliničkih znakova teškog vozilima do konja astma (ranije poznat kao рецидивирующая opstrukcija dišnih putova – (rao), ljetno pašnjak vezane relaps opstrukcija dišnih putova – (spa-rao)).

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptin - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - za odrasle pacijente s tip-2 dijabetesa, ristaben pokazala da poboljšanje glikemijski kontrole:kao monoterapija:kod pacijenata, neadekvatno kontroliranim s prehrane i vježbe sam i za koje metformin je nepraktično zbog kontraindikacija ili netrpeljivosti;kao dvostruki oralnu terapiju u kombinaciji sa:metforminom, kada dijeta i vježbe plus metformin sami ne pružaju adekvatnu glikemijski kontrole;sulfonilureje, kada dijeta i vježbe plus maksimalna podnosi doza sulfonilureje sami ne pružaju adekvatnu glikemijski kontrole, i kada metformin je nepraktično zbog kontraindikacija ili netrpeljivosti;u пролифераторами пероксисом-aktivirani receptor gama (ppary) agonist (ja. тиазолидиндионом), kada je upotreba agonista ppary je prikladno i kada dijeta i vježbe plus agonist ppary sami ne pružaju adekvatnu glikemijski kontrole;kao trostruka пероральная terapija u kombinaciji sa sulfonilurejom i metforminom, kada dijeta i vježbe plus dva terapija ovi lijekovi ne pružaju adekvatnu glikemijski kontrole;agonist ppary i metforminom kada se koristi agonista ppary je prikladno i kada dijeta i vježbe plus dva terapija ovi lijekovi ne pružaju adekvatnu glikemijski kontrole. ristaben također navodi kao dodatak na inzulin (sa ili bez метформина), kada dijeta i vježbe plus stabilne doze inzulina ne pružaju adekvatnu glikemijski kontrole.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - lijekovi za opstruktivne plućne bolesti dišnih putova, - asthma biresp spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β₂ adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β₂ adrenoceptor agonists. orin patients already adequately controlled on both inhaled corticosteroids and long-acting β₂ adrenoceptor agonists. copdbiresp spiromax is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev₁).

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - lijekovi za opstruktivne plućne bolesti dišnih putova, - asthma duoresp spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β₂ adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β₂ adrenoceptor agonists. orin patients already adequately controlled on both inhaled corticosteroids and long-acting β₂ adrenoceptor agonists. copdduoresp spiromax is indicated in adults, aged 18 years and older for the symptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev₁).

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

hospira uk limited - docetaxel trihidrat - stomach neoplasms; prostatic neoplasms; breast neoplasms; head and neck neoplasms; carcinoma, non-small-cell lung - antineoplastična sredstva - cancertaxespira dojke u kombinaciji s doksorubicin i ciklofosfamid je indiciran za adjuvantne terapije pacijenata s:aktivni čvor-pozitivan rak dojke;aktivni čvor-negativnim rakom dojke . za pacijente s операбельным čvor-negativnim rakom dojke, adjuvantne terapije trebalo bi biti ograničeno pravo bolesnika na primanje kemoterapije po međunarodnim kriterijima na primarne terapije ranog raka dojke . taxespira u kombinaciji s doksorubicin je namijenjen za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke, prethodno liječenih цитотоксической terapija za ovo stanje. taxespira monoterapija namijenjen je za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke neučinkovitosti terapije цитотоксической. prethodne kemoterapije moraju uključivati антрациклиновый ili алкилирующий agent. taxespira kombinaciji s трастузумабом namijenjen je za liječenje bolesnika s metastatskih tumora dojke, tumora koje express her2 i koji ranije nisu primali kemoterapiju o popularnog bolesti. taxespira u kombinaciji s капецитабином namijenjen je za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke neučinkovitosti цитотоксической kemoterapije. prethodna terapija mora sadržavati антрациклиновый. Немелкоклеточный rak pluća taxespira indiciran za liječenje bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным od raka pluća nakon neefikasnosti prethodne kemoterapije. taxespira u kombinaciji s цисплатином namijenjen je za liječenje bolesnika s нерезектабельным, lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća kod pacijenata koji nisu prethodno tretirani i kemoterapiju za ove uvjete. taxespira raka prostate u kombinaciji s преднизоном ili преднизолоном indiciran za liječenje bolesnika s hormonski uporan метастатического raka prostate . Аденокарцинома želuca taxespira u kombinaciji s цисплатином i 5-фторурацилом namijenjen je za liječenje bolesnika s метастатической аденокарциномой želuca, uključujući i gušterače adenokarcinom пищеводно-želučani tranzicije, koji nisu primili ranije kemoterapije za метастатической bolesti. rak glave i vrata taxespira u kombinaciji s цисплатином i 5-фторурацилом dizajniran za indukcijska terapija bolesnika s lokalno-najčešći плоскоклеточным raka glave i vrata.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

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.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

biopartners gmbh - somatropin - rast - pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists - somatropin biopartners je indiciran za zamjensku terapiju endogenog hormona rasta kod odraslih osoba s nedostatkom hormona rasta (ghd) kod djece ili odraslih,. odrasloj dobi: bolestan od ghd u odrasloj dobi definirana kao bolesnika s poznatom гипоталамо-hipofiza bolestima i najmanje jedan dodatni poznati nedostatak određenog hormona hipofize, osim пролактина. ovi bolesnici moraju proći jedan dinamički test kako bi se dijagnosticirati ili isključiti ДГР. djetinjasto dijabetesom: u bolesnika s dječjim dijabetesom izdvojeni ДГР (nema dokaza гипоталамо-гипофизарным bolest ili zračenje mozga), dva dinamička ispitivanja treba izvršiti nakon završetka rasta, uz izuzetak onih koji imaju niska razina inzulina kao faktora rasta-i (ИРФ-i) u koncentracijama (< -2 standardne devijacije rezultat (ИКБ)), koji se može smatrati za jednog testa. točku clipping, dinamičkog testa mora biti stroga.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

acorda therapeutics ireland limited - l-dopa - parkinsonova bolest - antiparkinsonski lijekovi - inbrija drugačije prekidima tijekom liječenja epizodne vibracija motora (video) kod odraslih pacijenata s parkinsonovom bolešću (pb) tretman s леводопы/dopa su-декарбоксилазы inhibitor.