Euroopa Liit - eesti - EMA (European Medicines Agency)

n.v. organon - nomegestrol atsetaat, östradiooli - kontraceptsioon - suguhormoonid ja genitaalsüsteemi, - suukaudne kontratseptsioon.

Euroopa Liit - eesti - EMA (European Medicines Agency)

aziende chimiche riunite angelini francesco s.p.a. - lurasidoon - skisofreenia - psühhoeptikumid - skisofreenia ravi 18-aastastel ja vanematel täiskasvanutel.

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)

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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, cobicistat - hiv-nakkused - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta on näidustatud koos teiste retroviirusevastaste ravimitega inimese immuunpuudulikkuse viiruse 1 (hiv 1) nakkuse raviks 18-aastastel ja vanematel täiskasvanutel. genotypic katsetamine peaks juhendi kasutamine rezolsta.

Euroopa Liit - eesti - EMA (European Medicines Agency)

gilead sciences ireland uc - cobicistat - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (hiv-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.

Euroopa Liit - eesti - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - kartsinoom, mitteväikerakk-kopsu - muud antineoplastilised ained, protein kinase inhibiitorid - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

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merck sharp & dohme b.v. - elbasvir, grazoprevir - c-hepatiit, krooniline - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 ja 5. c-hepatiidi viiruse (hcv) genotüüp-eriaktiivsus vt lõigud 4. 4 ja 5.

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roche registration ltd. - nelfinaviir - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - retroviiruste vastane kombineeritud ravi inimese-immuunpuudulikkuse-viiruse (hiv-1) on näidustatud viracept-infektsiooniga täiskasvanutel, noorukitel ja lastel kolm aastat ja vanemad. selles proteaas-inhibiitori (pi)-kogenud patsientidel, valik nelfinaviiri peaks põhinema individuaalsel viiruse resistentsuse testimise ja ravi ajalugu.

Euroopa Liit - eesti - EMA (European Medicines Agency)

gilead sciences international ltd - elvitegravir - hiv-nakkused - viirusevastased ravimid süsteemseks kasutamiseks - vitekta manustamine koos ritonaviiriga võimendatud proteaasi inhibiitori ja teiste retroviiruste vastaste on näidustatud inimese-immuunpuudulikkuse viirus-1 (hiv-1) infektsiooni raviks täiskasvanutel, kes on nakatunud hiv-1 ilma teadaolevate seotud elvitegraviiri.