Euroopa Liit - eesti - EMA (European Medicines Agency)

"anpharm" przedsiębiorstwo farmaceutyczne s.a. - ivabradiin - angina pectoris; heart failure - muud kardiaalsed preparaadid - sümptomaatiline ravi kroonilise stabiilse stenokardia pectorisivabradine on näidustatud sümptomaatiline ravi kroonilise stabiilse stenokardia puhul südame isheemiatõbi täiskasvanud normaalse siinus rütm ja pulss on ≥ 70 l / min. ivabradine on näidustatud:täiskasvanud suuda taluda või contra-tähise kasutamise beeta-blockersor kombinatsioonis beeta-blokaatorite patsientidel, ebapiisavalt kontrollitud optimaalne annus betablocker. ravi kroonilise südame failureivabradine on näidustatud kroonilise südamepuudulikkuse nyha ii-iv klassi süstoolne düsfunktsioon, patsientidel, siinus rütm ning kelle südame löögisagedus on ≥ 75 l / min, koos standard ravi, sh beeta-blokaatorid ravi või kui beeta-blokaatorid ravi on vastunäidustatud või ei ole talutav.

Euroopa Liit - eesti - EMA (European Medicines Agency)

jensonr+ limited - ivabradiinvesinikkloriid - angina pectoris; heart failure - südame teraapia - kroonilise stabiilse stenokardia sümptomaatiline ravi koronaararterite haiguse täiskasvanutel normaalse sinusurma ja südame löögisagedusega ≥ 70 löögi minutis. ivabradiin on näidustatud: - täiskasvanutel ei talu või kellel beetablokaatorite - või koos beetablokaatoritega patsientidel, optimaalne beetablokaatoriga annuse kasutamise vastunäidustuse. ravi kroonilise südamepuudulikkuse ivabradiin on näidustatud kroonilise südamepuudulikkuse nyha ii – iv klassi, patsientidel siinusrütm ja kelle pulsisagedus on üle 75 löögi minutis, sealhulgas beetablokaatoriga ravi koos või kuna beetablokaatoriga ravi on vastunäidustatud või mittetalutav.

Euroopa Liit - eesti - EMA (European Medicines Agency)

zentiva, k.s. - ivabradiinvesinikkloriid - angina pectoris; heart failure - südame teraapia - sümptomaatiline ravi kroonilise stabiilse stenokardia ivabradiin on näidustatud täiskasvanutel pärgarteri haigus normaalse siinusrütmiga südame löögisagedus minutis on ≥ 70 kroonilise stabiilse stenokardia sümptomaatiliseks raviks. ivabradine on näidustatud:täiskasvanud suuda taluda või contra-tähise kasutamise beeta-blockersorin koos beeta-blokaatorid patsientidel, ebapiisavalt kontrollitud optimaalne beeta-blokaatorid annus. ravi kroonilise südamepuudulikkuse ivabradiin on näidustatud kroonilise südamepuudulikkuse nyha ii – iv klassi, patsientidel siinusrütm ja kelle pulsisagedus on üle 75 löögi minutis, sealhulgas beetablokaatoriga ravi koos või kuna beetablokaatoriga ravi on vastunäidustatud või mittetalutav.

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis europharm limited - ruxolitiniib (fosfaadina) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastilised ained - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. polycythaemia vera (pv)jakavi on näidustatud ravi täiskasvanud patsientidel, kellel polycythaemia vera, kes on resistentsed või sallimatu hydroxyurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Euroopa Liit - eesti - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - palifermiin - mukosiit - kõik muud ravitoimingud - kepivance on näidustatud vähenenud esinemissageduse, kestuse ja raskusastme esinemissageduse täiskasvanud patsientidel, kes saavad müeloablatiivset radiochemotherapy seotud koosnevaid raske mukosiit ja nõuavad autoloogne---vereloome tugi.

Euroopa Liit - eesti - EMA (European Medicines Agency)

hra pharma rare diseases - ketokonasool - cushingi sündroom - antimükoosid süsteemseks kasutamiseks - ketoconazole hra on näidustatud täiskasvanutel ja noorukitel alates 12 aasta vanusest endogeense cushingi sündroomiga.

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - 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 - antineoplastilised ained - 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. patsiendid, kellel on egfr-või kristallimise positiivne kasvaja mutatsioonid peaks ka saanud suunatud ravi enne saanud keytruda. 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

eli lilly nederland b.v. - olaratumab - sarkoom - antineoplastilised ained - lartruvo on näidustatud täiskasvanud patsientidel kaugelearenenud pehmete kudede sarkoom, kes ei ole sobivad, tervendavat operatsiooni või kiiritusravi ravi ja kes ei ole varem töödeldud ravi doksorubitsiiniga doksorubitsiiniga (vt lõik 5.

Euroopa Liit - eesti - EMA (European Medicines Agency)

immunomedics gmbh - sulesomab - osteomyelitis; radionuclide imaging - diagnostilised ained - see ravim on mõeldud ainult diagnostiliseks kasutamiseks. leukoscan on näidustatud diagnostiliste määramise asukoht ja ulatus nakkus/põletik luu patsientidel, kellel kahtlustatakse osteomüeliit, sealhulgas patsientidel, kellel on diabeetiline suu haavandid. leukoscan ei ole hõivatud, et diagnoosida osteomüeliit patsientidel, kellel on sirprakuline aneemia.

Euroopa Liit - eesti - EMA (European Medicines Agency)

astrazeneca ab - roflumilast - kopsuhaigus, krooniline obstruktiivne - ravimid hingamisteede obstruktiivsete haiguste, - libertek on näidustatud säilitusraviks raske krooniline obstruktiivne kopsuhaigus (kok) (fev1 pärast bronhodilataatori vähem kui 50% ennustatud) täiskasvanud patsientidel, kellel on esinenud sagedased ägenemised täiendava ravimina kroonilise bronhiidiga seotud et kasutamiseks bronhe.