Evropska unija - estonščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - icatibant acetate - angioödeem, pärilik - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.

Evropska unija - estonščina - EMA (European Medicines Agency)

orion corporation - tasipimidine sulfate - other hypnotics and sedatives - koerad - alleviation of situational anxiety and fear in dogs triggered by e. travel, noise, owner departure, veterinary visits.

Evropska unija - estonščina - EMA (European Medicines Agency)

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

Evropska unija - estonščina - EMA (European Medicines Agency)

agios netherlands b.v. - mitapivat sulfate - genetic diseases, inborn; anemia, hemolytic - other hematological agents - pyrukynd is indicated for the treatment of pyruvate kinase deficiency (pk deficiency) in adult patients (see section 4.

Evropska unija - estonščina - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemofiilia b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

Evropska unija - estonščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - zonisamiid - epilepsia - antiepileptics, - monotherapy ravi osaline krambid koos või ilma sekundaarse teha üldistusi, täiskasvanud, kellel on äsja diagnoositud epilepsia;adjunctive ravi ravi osaline krambid koos või ilma sekundaarse teha üldistusi, täiskasvanutel, noorukitel ja lastel vanuses 6 aastat ja vanemad.

Evropska unija - estonščina - EMA (European Medicines Agency)

linde healthcare ab - lämmastikoksiidi - hypertension, pulmonary; respiratory insufficiency - muud hingamisteede tooted - inomax koos ventilatoorsed ja muud vajalikud toimeained, mis on märgitud:ravi vastsündinud imikud ≥34 nädalat tiinus koos hüpoksiline hingamispuudulikkus seotud kliiniliste või echocardiographic tõendeid pulmonaalse hüpertensiooniga, et parandada hapnikuga ja vähendada vajadust extracorporeal membrane hapnikuga;osana ravi peri - ja operatsioonijärgse pulmonaalse hüpertensiooniga täiskasvanutel ja vastsündinud imikud imikud ja väikelapsed, lapsed ja noorukid, vanuses 0-17 aastat koos südame operatsiooni, selleks, et valikuliselt vähendada pulmonaalse arteriaalse rõhu ja parandada parema vatsakese funktsiooni ja hapnikuga.

Evropska unija - estonščina - EMA (European Medicines Agency)

janssen-cilag international nv - darunaviiri - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Evropska unija - estonščina - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetrexed disodium, pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastilised ained - malignant pleural mesotheliomapemetrexed pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Evropska unija - estonščina - EMA (European Medicines Agency)

novartis europharm limited - brinsolamiidi, brimonidine tartraat - ocular hypertension; glaucoma, open-angle - oftalmoloogilised vahendid - kõrge silmasisese rõhu (iop) vähenemine avatud nurga glaukoomi või okulaarse hüpertensiooniga täiskasvanud patsientidel, kellel monoteraapia annab iop-i vähesuse.