European Union - Estonian - EMA (European Medicines Agency)

janssen-cilag international n.v. - paliperidoonpalmitaat - skisofreenia - psühhoeptikumid - xeplion on näidustatud skisofreenia säilitamiseks täiskasvanud patsientidel, kes stabiliseerusid paliperidooni või risperidooniga. in selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

European Union - Estonian - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - fluticasone furoaat, vilanterol - kopsuhaigus, krooniline obstruktiivne - adrenergia ja muud ravimid obstruktiivsete hingamisteede haiguste raviks - astma märge:relvar ellipta on näidustatud regulaarne astma ravi täiskasvanutel ja noorukitel vanuses 12 aastat ja vanemad, kui kombinatsiooni kasutamine toote (pikatoimeline beeta-2 agonisti ja inhaleeritava kortikosteroidi) on asjakohane:patsientidel ei ole piisavalt kontrollitud inhaleeritava kortikosteroide ja "nii nagu vaja" sisse hingata lühikese toimeajaga beeta-2 agonistide. patsiendid juba piisavalt kontrollitud, nii inhaleeritava kortikosteroidi ja pikatoimeline beeta-2 agonisti. copd märge:relvar ellipta on näidustatud sümptomaatiline ravi täiskasvanud copd koos fev1.

European Union - Estonian - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - fluticasone furoaat, vilanterol trifenatate - astma - adrenergia ja muud ravimid obstruktiivsete hingamisteede haiguste raviks - astma indicationrevinty ellipta on näidustatud regulaarne astma ravi täiskasvanutel ja noorukitel vanuses 12 aastat ja vanemad, kui kombinatsiooni kasutamine toote (pikatoimeline beeta-2 agonisti ja inhaleeritava kortikosteroidi) on asjakohane:patsientidel ei ole piisavalt kontrollitud inhaleeritava kortikosteroide ja "nii nagu vaja" sisse hingata lühikese toimeajaga beeta-2 agonistide. copd indicationrevinty ellipta on näidustatud sümptomaatiline ravi täiskasvanud copd koos fev1.

European Union - Estonian - EMA (European Medicines Agency)

novartis europharm limited - telbivudiin - b-hepatiit, krooniline - nukleosiidide ja nukleotiidide pöördtranskriptaasi inhibiitorid - sebivo on näidustatud kroonilise b-hepatiidi raviks kompenseeritud maksahaigusega täiskasvanud patsientidel ja viiruse replikatsiooni, püsivalt suurenenud seerumi alaniini aminotransferaasi (alat) tasemed ja histoloogiliselt kinnitatud aktiivne põletik ja/või. algatamise sebivo-ravi tuleks kaaluda ainult juhul, kui kasutada alternatiivset viirusevastane esindaja suurem geneetiline barjäär, et vastupidavus pole võimalik või asjakohane.

European Union - Estonian - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - venetoclax - leukeemia, lümfotsüütne, krooniline, b-rakk - antineoplastilised ained - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

European Union - Estonian - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - fentanüül - pain; cancer - valuvaigistid - pecfent on näidustatud läbilöögivalu juhtimiseks täiskasvanutel, kes saavad kroonilise vähivastase valu alustamist hooldus opioidideks. läbimurrevalu on vahelduv valu ägenemine, mis esineb muidu kontrollitud püsiva valu taustal. saavate patsientide hooldus opioidide ravi on need, kes on võttes vähemalt 60 mg suukaudset morfiini päevas, vähemalt 25 mikrogrammi transdermaalset fentanüüli tunnis, vähemalt 30 mg oksükodoon päevas, vähemalt 8 mg suukaudse hüdromorfoon iga päev või equi-valuvaigistav annus teise opioidi ühe nädala jooksul või kauem,.

European Union - Estonian - EMA (European Medicines Agency)

sandoz gmbh - filgrastiim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - vähendamine kestus neutropenia ja esinemissagedus febriilsed neutropenia patsientidel, keda on ravitud asutatud tsütotoksilist keemiaravi jaoks pahaloomulise kasvaja (välja arvatud krooniline müeloidne leukeemia ja müelodüsplastiline sündroom) ja vähenemine kestus neutropenia patsientidel toimumas myeloablative ravi, millele järgneb luuüdi siirdamine leidis, et olla suurenenud risk pikaajalise raske neutropenia. filgrastiimi ohutus ja efektiivsus on täiskasvanutel ja lastel, kes saavad tsütotoksilist kemoteraapiat. mobiliseerimine perifeerse vere eelkäijad rakkude (pbpc). lastel ja täiskasvanutel, kellel on raske kaasasündinud, tsüklilise või idiopaatilise neutropenia koos absoluutse neutrofiilide arvu (anc) ≤0. 5 x 109/l ning on esinenud tõsised või korduvad infektsioonid, pikaajalise haldus-filgrastim, mis on märgitud suurendab neutrofiilide arvu ja vähendada nende esinemissagedust ja kestvust nakkuse seotud üritused. ravi püsivad neutropenia (anc ≤ 1. 0 x 109/l) patsientidel, kaugelearenenud hiv-infektsioon, selleks et vähendada riski, bakteriaalsete infektsioonide, kui muud ravivõimalused ei sobi.

European Union - Estonian - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastilised ained - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

European Union - Estonian - EMA (European Medicines Agency)

csl behring gmbh - inimese normaalne immunoglobuliin (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - suguhormoonid ja immunoglobuliinid, - asendamine ravi täiskasvanutel, lastel ja noorukitel (0-18 aastat): primaarsed immuunpuudulikkuse (pid) sündroomid häirega antikehade tootmist;hypogammaglobulinaemia ja korduvate bakteriaalsete nakkuste raviks patsientidel, kellel on krooniline lümfoidne leukeemia, kellest profülaktika antibiootikumidega on ebaõnnestunud;hypogammaglobulinaemia ja korduvate bakteriaalsete infektsioonide platoo-etapp-mitu-myeloma patsientidel, kes on allunud pneumokoki vaktsineerimist;hypogammaglobulinaemia patsientidel pärast allogeensete vereloome-tüvirakkude siirdamine (hsct);kaasasündinud aids korduvate bakteriaalsete infektsioonide. immunomodulation täiskasvanutel, lastel ja noorukitel (0-18 aastat): esmane trombotsütopeenia immuunsüsteemi (itp) patsientidel on suur risk verejooksu või enne operatsiooni, et parandada trombotsüütide arv;guillain-barré sündroom;kawasaki haigus;krooniline põletikuline demüeliniseerivate polüneuropaatia (cidp). ainult piiratud kogemused on saadaval kasutamise intravenoosse immunoglobuliinid lastel cidp.

European Union - Estonian - EMA (European Medicines Agency)

proveca pharma limited - glycopyrronium bromiid - sialorröa - funktsionaalsete seedetrakti häirete ravimid - tõsise sialorröa sümptomaatiline ravi (krooniline patoloogiline sularahustamine) 3-aastastel ja vanematel lastel ja noorukitel krooniliste neuroloogiliste haigustega.