Euroopa Liit - eesti - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil vesinikkloriid - kolorektaalne kasvaja - antineoplastilised ained - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Euroopa Liit - eesti - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - bimatoprost - glaucoma, open-angle; ocular hypertension - prostaglandin analogues, ophthalmologicals - suurenenud silmasisese rõhu langus kroonilise avatud nurga glaukoomi ja silma hüpertensioonina (monoteraapiana või beeta-adrenoblokaatorite täiendava ravina).

Euroopa Liit - eesti - EMA (European Medicines Agency)

pharmathen s.a. - levetiratsetaam - epilepsia - antiepileptics, - matever on näidustatud monoteraapiaga kaasasündinud epilepsiahoogude ravis koos sekundaarse generaliseerumisega või ilma selleta 16-aastastel patsientidel äsja diagnoositud epilepsiaga. matever on näidustatud adjunctive ravi:ravi osalisel algusega krambid koos või ilma sekundaarse teha üldistusi täiskasvanutele, lastele ja imikutele alates ühe kuu vanuses epilepsia;ravi myoclonic krampide täiskasvanutele ja noorukitele alates 12 aasta vanusest juveniilse myoclonic epilepsia;ravi-primaarse generaliseerunud tonic-clonic krambid täiskasvanutel ja noorukitel alates 12-aastastel idiopaatilise generaliseerunud epilepsia.

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis europharm limited - trametiniib - melanoom - antineoplastilised ained - melanomatrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 ja 5. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy (see section 5. adjuvant treatment of melanomatrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection. mitteväikerakk-kopsuvähk (mitteväikerakk-kopsuvähi)trametinib koos dabrafenib on näidustatud ravi täiskasvanud patsientidel, kaugelearenenud mitteväikerakk-kopsuvähi, mille braf v600 mutatsioon.

Euroopa Liit - eesti - EMA (European Medicines Agency)

nordic group b.v. - metotreksaadi - arthritis, psoriatic; psoriasis; arthritis, juvenile rheumatoid; arthritis, rheumatoid - antineoplastilised ained - nordimet is indicated for the treatment of:active rheumatoid arthritis in adult patients,polyarthritic forms of severe, active juvenile idiopathic arthritis (jia), when the response to nonsteroidal anti-inflammatory drugs (nsaids) has been inadequate,moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients, induction of remission in moderate steroid-dependent crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.

Euroopa Liit - eesti - EMA (European Medicines Agency)

hospira uk limited - dotsetakseel trihüdraat - stomach neoplasms; prostatic neoplasms; breast neoplasms; head and neck neoplasms; carcinoma, non-small-cell lung - antineoplastilised ained - rindade cancertaxespira koos doxorubicin ja tsüklofosfamiidiga on näidustatud abiaine ravi patsientidel, kellel on:toimiv node-positiivne rinnanäärmevähk;toimiv node-negatiivne rinnanäärmevähk. patsientidel, kellel on toimiv node-negatiivne rinnanäärmevähk, abiainet ravi peaks olema piiratud, et patsientidel on õigus saada keemiaravi vastavalt rahvusvaheliselt kehtestatud kriteeriumid esmane ravi varajases rinnavähi. taxespira koos doxorubicin on näidustatud ravi patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise rinnavähi kes ei ole varem saanud tsütotoksilist ravi selle tingimuse. taxespira monotherapy on näidustatud ravi patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise rinnavähi pärast rikke tsütotoksiline ravi. eelmine keemiaravi peaks sisaldama antratsükliini või alküülivat ainet. taxespira koos trastuzumab on näidustatud ravi metastaatilise rinnavähi, kelle kasvajad üle express her2 ja kes eelnevalt ei ole saanud keemiaravi jaoks metastaatilise haiguse. taxespira koos capecitabine on näidustatud ravi patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise rinnavähi pärast rikke tsütotoksilist keemiaravi. eelnev ravi peaks sisaldama antratsükliini. non-small cell lung cancer taxespira näidustatud ravi patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise mitteväikerakk-kopsuvähi pärast rikke enne keemiaravi. taxespira koos cisplatin on näidustatud patsientide raviks unresectable, lokaalselt kaugelearenenud või metastaatilise mitteväikerakk-kopsuvähi raviks patsientidel, kes ei ole varem saanud keemiaravi selle seisukord. eesnäärme vähk taxespira kombinatsioonis prednisooni või prednisolooni on näidustatud patsientide raviks hormoon tulekindlad metastaatilise eesnäärmevähiga. mao adenocarcinoma taxespira koos cisplatin ja 5-fluorouratsiili on näidustatud ravi metastaatilise mao adenocarcinoma, sealhulgas adenocarcinoma kohta gastroesophageal ristmikul, kes ei ole eelnevalt saanud keemiaravi jaoks metastaatilise haiguse. pea ja kaelapiirkonna vähk taxespira koos cisplatin ja 5-fluorouratsiili on näidustatud induktsiooni ravi patsientidel, kellel on lokaalselt kaugelearenenud soomusrakuline kartsinoom pea ja kael.

Euroopa Liit - eesti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - abatacept - arthritis, psoriatic; arthritis, juvenile rheumatoid; arthritis, rheumatoid - immunosupressandid - reumatoidartriidi arthritisorencia, koos metotreksaadi, on näidustatud:ravi mõõduka kuni raske aktiivse reumatoidartriidi (ra) täiskasvanud patsientidel, kes vastas valesti, et eelmise ravi ühe või mitme haigust moduleeriva anti-reumaatilised drugs (dmards), sealhulgas metotreksaadi (mtx) või tuumori nekroosi faktori (tnf)-alfa inhibiitori. ravi väga aktiivse ja progresseeruva haigusega täiskasvanud reumatoidartriidiga patsientidel ei olnud varem ravitud metotreksaadi. vähendamine progresseerumise liigeskahjustusi ja parandamine, füüsilise funktsiooni on tõendatud jooksul kombineeritud ravi abatacept ja metotreksaadi. psoriaatilise arthritisorencia, üksi või koos metotreksaadi (mtx), on näidustatud ravi aktiivne psoriaatiline artriit (psa) täiskasvanud patsientidel, kui vastus eelmisele dmard ravi, sh mtx on olnud ebapiisavad, ja kelle jaoks täiendav süsteemse ravi psoriaatilise naha kahjustused ei ole vajalik. polüartikulaarse juveniilse idiopaatilise arthritisorencia koos metotreksaadi on näidustatud ravi mõõduka kuni raske aktiivse juveniilse idiopaatilise artriidi (pjia) pediaatrilised patsiendid 2-aastased ja vanemad, kes on ebaadekvaatne reaktsioon eelmise dmard ravi. orencia on võimalik antud monotherapy juhul, talu metotreksaati või kui ravi metotreksaadi on kohatu.

Euroopa Liit - eesti - EMA (European Medicines Agency)

advanz pharma limited - obeticholic happega - maksatsirroos, sapiteet - vere ja maksa ravi - ocaliva on näidustatud esmase sapiteede kolangiit (ka esmane maksatsirroos) koos ursodeoxycholic hape (udca) täiskasvanutel ja kes ei udca või monoteraapiana täiskasvanud ei talu udca.

Euroopa Liit - eesti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastilised ained - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4. 4 ja 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.

Euroopa Liit - eesti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastilised ained - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.