Euroopa Liit - eesti - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - ambrisentaan - hüpertensioon, kopsuvähk - antihypertensives, - volibris is indicated for treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment (see section 5.  efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease. volibris is indicated for treatment of pah in adolescents and children (aged 8 to less than 18 years) of who functional class (fc) ii to iii including use in combination treatment. efficacy has been shown in ipah, familial, corrected congenital and in pah associated with connective tissue disease (see section 5.

Euroopa Liit - eesti - EMA (European Medicines Agency)

astrazeneca ab - naatrium mangaan cyclosilicate - hüperkaleemia - kõik muud ravitoimingud - lokelma on näidustatud ravi hyperkalaemia täiskasvanud patsiendid.

Euroopa Liit - eesti - EMA (European Medicines Agency)

krka d.d. - pemetrexed dinaatrium - - carcinoma, non-small-cell lung; mesothelioma - antineoplastilised ained - pleura pahaloomulise mesotheliomapemetrexed krka koos cisplatin on näidustatud ravi keemiaravi naiivne patsientidel unresectable pleura pahaloomulise mesotelioomi. non-small cell lung cancerpemetrexed krka koos cisplatin on näidustatud esimese rea raviks patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise mitteväikerakk-kopsuvähi raviks, v.a peamiselt soomusrakuline rakkude histoloogia. pemetrexed krka on näidustatud monotherapy hooldus-ravi lokaalselt kaugelearenenud või metastaatilise mitteväikerakk-kopsuvähi raviks, v.a peamiselt soomusrakuline rakkude histoloogia patsientidel, kelle haigus ei ole jõudnud kohe pärast plaatina-põhinevat keemiaravi. pemetrexed krka on näidustatud monotherapy teise rea ravi patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise mitteväikerakk-kopsuvähi raviks, v.a peamiselt soomusrakuline rakkude histoloogia.

Euroopa Liit - eesti - EMA (European Medicines Agency)

recordati ireland ltd - silodosiin - eesnäärme hüperplaasia - urologicals, alfa-adrenoreceptor antagonistid - ravi nähud ja sümptomid eesnäärme healoomulise hüperplaasia (bph), täiskasvanud mehed.

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis europharm limited  - brolucizumab - märg macula degeneration - oftalmoloogilised vahendid - beovu on näidustatud täiskasvanute raviks neovascular (märg) vanusega seotud makuladegeneratsiooni (amd).

Euroopa Liit - eesti - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - seedetraktist esinevad stromaal-kasvajad - muud antineoplastilised ained, protein kinase inhibiitorid - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Euroopa Liit - eesti - EMA (European Medicines Agency)

amarin pharmaceuticals ireland limited - icosapent ethyl - düslipideemiad - lipiidi modifitseerivad ained - indicated to reduce cardiovascular risk as an adjunct to statin therapy.

Euroopa Liit - eesti - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastilised ained - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patsientidel, kellel on madal või väga madal risk kordumise ei tohiks saada abiaine ravi. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. välja arvatud äsja diagnoositud kroonilise faasi cml, ei ole kontrollitud uuringud, mis näitab kliiniline kasu või suurenenud ellujäämise eest need haigused.

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - kartsinoom, mitteväikerakk-kopsu - antineoplastilised ained - tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Euroopa Liit - eesti - EMA (European Medicines Agency)

roche registration gmbh - faricimab - wet macular degeneration; macular edema; diabetes complications - oftalmoloogilised vahendid - vabysmo is indicated for the treatment of adult patients with:neovascular (wet) age-related macular degeneration (namd),visual impairment due to diabetic macular oedema (dme).