Euroopa Liit - eesti - EMA (European Medicines Agency)

samsung bioepis nl b.v. - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; myopia, degenerative - oftalmoloogilised vahendid - byooviz is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

Euroopa Liit - eesti - EMA (European Medicines Agency)

stada arzneimittel ag - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - oftalmoloogilised vahendid - ximluci is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

Euroopa Liit - eesti - EMA (European Medicines Agency)

viatris limited - klopidogreel-besilaat - peripheral vascular diseases; stroke; myocardial infarction - antitrombootilised ained - secondary prevention of atherothrombotic events clopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. adult patients suffering from acute coronary syndrome. non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa). st segmendi elevatsiooniga ägeda müokardi infarkti korral kombinatsioonis asa on meditsiiniliselt ravitud patsientide abikõlblikud trombolüütiline ravi. in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is) clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2 score ≥4) or minor is (nihss ≤3) within 24 hours of either the tia or is event. prevention of atherothrombotic and thromboembolic events in atrial fibrillation:in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke. täiendava teabe jaoks vt osa 5.

Euroopa Liit - eesti - EMA (European Medicines Agency)

taw pharma (ireland) limited - klopidogreelvesinikkloriid - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antitrombootilised ained - , , , , secondary prevention of atherothrombotic events, , clopidogrel is indicated in: , - adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. , - adult patients suffering from acute coronary syndrome:,    - non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa). ,     - st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy. , , in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is), clopidogrel in combination with asa is indicated in:, - adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event.  , , prevention of atherothrombotic and thromboembolic events in atrial fibrillation, in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke. , , for further information please refer to section 5. , , ,.

Euroopa Liit - eesti - EMA (European Medicines Agency)

janssen-cilag international n.v.    - rilpiviriini vesinikkloriid - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - edurant, kombinatsioonis teiste retroviirusevastaste ravimitega on näidustatud raviks inimese immuunpuudulikkuse viiruse tüüp 1 (hiv‑1) nakkuse retroviirusevastaste treatment‑naïve patsientidel 12 aastat ja vanemad koos viiruse hulk ≤ 100 000 hiv‑1 rna koopiat/ml. nagu ka teiste viirusevastase ravimitega, genotypic vastupanu testimine peaks juhendi kasutamine edurant.

Euroopa Liit - eesti - EMA (European Medicines Agency)

viiv healthcare bv - lamivudiin - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - epivir on näidustatud retroviirusevastaseks kombineeritud raviks inimese-immuunpuudulikkuse-viiruse (hiv) osana-nakatunud täiskasvanutel ja lastel.

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis europharm limited - imatiniib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastilised ained - glivec is indicated for the treatment of , adult 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-pdgfra rearrangement. mõju glivec tulemuste kohta luu-üdi siirdamine ei ole kindlaks. glivec is indicated for: , the 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; ravi täiskasvanud patsientidel, kellel unresectable dermatofibrosarcoma protuberans (dfsp) ja täiskasvanud patsientidel korduva ja / või metastaatilise dfsp, kes ei ole abikõlblikud operatsioon. , täiskasvanud ja pediaatriliste patsientide, tõhususe glivec põhineb üldine hematoloogiline ja tsütogeneetiline ravivastus, ja progression-free survival in cml, hematoloogiline ja tsütogeneetiline ravivastus, ph+ all, mds / mpd, hematoloogiline ravivastus, in hes / cel ja objektiivne ravivastus, täiskasvanud patsientidel unresectable ja / või metastaatilise pÕhisisu ja dfsp ja kordumise-free survival in abiaine pÕhilised. kogemus glivec patsientidel mds / mpd seotud pdgfr geeni taas-kord on väga piiratud (vt lõik 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)

chiesi farmaceutici s.p.a. - cangrelor - acute coronary syndrome; vascular surgical procedures - antitrombootilised ained - kengrexali, manustatuna koos atsetüülsalitsüülhappega (ash), on näidustatud täiskasvanud patsientidel kardiovaskulaarse tromboosi südame isheemiatõbi, kellele tehti perkutaanse koronaarse interventsiooni (pci), kes on saanud asja suulise p2y12 inhibiitor pci menetlust ja kellel suukaudse ravi p2y12 inhibiitoritega ei ole võimalik või soovitav.

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis europharm limited - ceritiniib - kartsinoom, mitteväikerakk-kopsu - antineoplastilised ained - zycadia on näidustatud eelnevalt krosotiiniibiga ravitud anaplastilise lümfoomi kinaasi (alk) positiivse arenenud mitteväikerakk-kopsuvähi (nsclc) täiskasvanud patsientide raviks.

Euroopa Liit - eesti - EMA (European Medicines Agency)

pfizer europe ma eeig - inotuzumab ozogamicin - prekursorko-lümfoblastne leukeemia-lümfoom - antineoplastilised ained - besponsa on monoteraapiana retsidiveerunud või tuleohtliku cd22-positiivse b-rakulise prekursori ägeda lümfoblastilise leukeemia (all) täiskasvanute raviks.. täiskasvanud patsientidel, kellel philadelphia kromosoomiga positiivse (ph+) taastekkinud või tulekindlad b-raku eellased kÕik peaks olema ebaõnnestunud ravi vähemalt 1 türosiinkinaasi inhibiitor (tki).