Eesti - eesti - Ravimiamet

laboratorios basi industria farmaceutica s.a. - diasepaam - süstelahus - 5mg 1ml 2ml 50tk

Eesti - eesti - Ravimiamet

mepha-investigacao, desenvolvimento e fabricacao farmaceutica, lda - asitromütsiin - õhukese polümeerikattega tablett - 500mg 2tk; 500mg 30tk; 500mg 6tk; 500mg 150tk

Eesti - eesti - Ravimiamet

mepha-investigacao, desenvolvimento e fabricacao farmaceutica, lda - asitromütsiin - õhukese polümeerikattega tablett - 250mg 4tk; 250mg 6tk; 250mg 3tk; 250mg 100tk

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis europharm limited  - onasemnogene abeparvovec - lihase atroofia, spinaalne - muud lihas-skeleti süsteemi häirete ravimid - zolgensma on näidustatud ravi:patsiendid, kellel on 5q seljaaju lihaste atroofia (sma) koos bi-allelic mutatsioon smn1 geeni-ja kliinilise diagnoosi akti liik 1, orpatients koos 5q sma koos bi-allelic mutatsioon smn1 geeni-ja kuni 3 koopiad smn2 geenide.

Euroopa Liit - eesti - EMA (European Medicines Agency)

astrazeneca ab - olaparib - munasarjade kasvajad - antineoplastilised ained - munasarja cancerlynparza on näidustatud monotherapy eest:hooldus ravi täiskasvanud patsientidel, kellel on arenenud (figo etapid iii ja iv) brca1/2-muteerunud (germline ja/või somaatilise) kõrge-klassi epiteeli munasarja -, munajuha-või esmase peritoneaaldialüüsi vähi, kes on vastuseks (täielik või osaline) pärast lõpetamist esimese-line platinum põhineva keemiaravi. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 ja 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. patsientidel peaks olema varem ravitud mõne anthracycline ja taxane aastal (neo)abiaine või metastaatilise seade välja arvatud juhul, kui patsientidele ei sobi nende ravi (vt lõik 5. patsiendid, kellel on hormooni retseptori (hr)-positiivse rinnavähi peaks ka jõudnud või pärast eelneva endokriinse ravi, või pidada sobi endokriinse ravi. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Euroopa Liit - eesti - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivakaftoor - tsüstiline fibroos - muud hingamisteede tooted - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 ja 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 ja 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna on näidustatud ravi täiskasvanud ja pediaatriliste patsientide nägemise kaotuse tõttu päritud võrkkesta dystrophy põhjustatud kinnitas biallelic rpe65 mutatsioonid ja kes on piisavalt elujõuline võrkkesta rakke.

Euroopa Liit - eesti - EMA (European Medicines Agency)

ptc therapeutics international limited - eladocagene exuparvovec - aminohapete ainevahetus, kaasasündinud vead - enzymes, other alimentary tract and metabolism products - upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic l amino acid decarboxylase (aadc) deficiency with a severe phenotype (see section 5.

Euroopa Liit - eesti - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - selektiivsed immunosupressandid - haavandiline colitisentyvio on näidustatud ravi täiskasvanud patsientidel mõõduka kuni raske aktiivse haavandilise koliidi, kes on ebaadekvaatne reaktsioon, kadunud vastuse, või olid sallimatu kas tavalise ravi või tuumori nekroosi faktor α (tnfa) antagonist. crohni diseaseentyvio on näidustatud ravi täiskasvanud patsientidel mõõduka kuni raske aktiivse crohni tõbi, kes on ebaadekvaatne reaktsioon, kadunud vastuse, või olid sallimatu kas tavalise ravi või tuumori nekroosi faktor α (tnfa) antagonist. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Euroopa Liit - eesti - EMA (European Medicines Agency)

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin meglumine - Ühenduse omandatud infektsioonid - antibacterials süsteemseks kasutamiseks, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 ja 5. tuleks arvesse võtta ametlikke juhiseid sobiva kasutada antibakteriaalseid aineid.