Euroopa Liit - eesti - EMA (European Medicines Agency)

gedeon richter plc. - drospirenone, estetrol monohydrate - contraceptives, oral - suguhormoonid ja genitaalsüsteemi, - oral contraceptive.

Euroopa Liit - eesti - EMA (European Medicines Agency)

estetra sprl - estetrol monohydrate, drospirenone - contraceptives, oral - suguhormoonid ja genitaalsüsteemi, - suukaudne kontratseptsioon. the decision to prescribe lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (vte), and how the risk of vte with lydisilka compares with other combined hormonal contraceptives (chcs) (see sections 4. 3 and 4.

Euroopa Liit - eesti - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastilised ained - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

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)

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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastilised ained - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

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)

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)

viatris limited - tadalafiil - hüpertensioon, kopsuvähk - uroloogilised ravimid - talmanco on näidustatud who ii ja iii funktsionaalse klassi klassifitseeritud kopsuarteri hüpertensiooni (pah) raviks täiskasvanutel, et parandada treenimisvõimet. efektiivsust on näidatud idiopaatiliste pah-de (ipah) ja kollageen-vaskulaarhaigusega seotud pah-de puhul.

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - letermovir - tsütomegaloviiruse infektsioonid - viirusevastased ravimid süsteemseks kasutamiseks - prevymis on näidustatud tsütomegaloviiruse (cmv) reaktiveerumine ja täiskasvanud cmv-seropositiivsete saajate [r +] allogeenset hematopoeetiliste tüvirakkude transplantatsioon (htt) haiguse. tuleks arvesse võtta ametlikke juhiseid sobiva kasutamise kohta viirusevastane ained.