Eistland - eistneska - Ravimiamet

alfa wassermann s.p.a - rifaksimiin - kaetud tablett - 200mg 12tk

Eistland - eistneska - Ravimiamet

alfasigma s.p.a. - rifaksimiin - kaetud tablett - 200mg 28tk; 200mg 12tk

Evrópusambandið - eistneska - EMA (European Medicines Agency)

astrazeneca ab - metformiin vesinikkloriid, dapagliflozin propaandiool monohüdraat - suhkurtõbi, tüüp 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - xigduo on näidustatud täiskasvanute raviks, kui 2. tüüpi suhkurtõve lisandina toitumise ja treeningu:• patsientidel, ebapiisavalt kontrollitud nende maksimaalne talutav annus metformiin üksi • koos teiste ravimitega ravi diabeedi patsientidel, ebapiisavalt kontrollitud metformiin ja need ravimid• patsientidel, juba ravitakse kombinatsioon dapagliflozin ja metformiin kui eraldi tabletid. uuringu tulemused seoses kombinatsiooni teraapia, mõju glycaemic kontrolli ja kardiovaskulaarsete sündmuste ja elanikkonna uuritud, vt punktid 4. 4, 4. 5 ja 5.

Evrópusambandið - eistneska - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propaandiool monohüdraat, metformiin vesinikkloriid - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - tüüp 2 diabeet mellitusfor ravi piisavalt kontrollitud tüüp 2 diabeet lisandina, et toitumine ja treening. kui monotherapy kui metformiin on ebasobivaks, kuna sallimatuse. lisaks teiste ravimitega ravi 2. tüüpi diabeedi. uuringu tulemused seoses kombinatsiooni teraapia, mõju glycaemic kontrolli ja kardiovaskulaarsete sündmuste ja elanikkonna uuritud, vt punktid 4. 4, 4. 5 ja 5. 1. tüüpi diabeet mellitusedistride on näidustatud täiskasvanute raviks, kui ebapiisavalt kontrollitud tüüp 1 diabeet lisandina, et insuliiniga patsientidel, kelle kmi on ≥ 27 kg/m2, kui insuliiniga üksi ei anna adekvaatset glycaemic kontrolli hoolimata optimaalset insuliini ravi.

Evrópusambandið - eistneska - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. vt lõigud 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Evrópusambandið - eistneska - EMA (European Medicines Agency)

novartis europharm limited  - siponimod fumaarhape - sclerosis multiplex, relapsing-remitting - selektiivsed immunosupressandid - mayzent on näidustatud ravi täiskasvanud patsientidel, kellel on sekundaarse progresseeruva sclerosis multiplex (spms) aktiivne haiguse tõendab ägenemiste või kujutise omadused põletikuline aktiivsus.

Evrópusambandið - eistneska - EMA (European Medicines Agency)

molmed spa - allogeense t rakke geneetiliselt muundatud retroviiruse vektori kodeering ma kärbitud kujul inimeste madal afiinsus närvi kasvufaktori retseptori (Δlngfr) ja herpes simplex viiruse tümidiinkinaasi (hsv-tk mut2 päriliku mutageensuse imetajate) - hematopoietic stem cell transplantation; graft vs host disease - antineoplastilised ained - zalmoxis on märgitud haploidentical vereloome tüvirakkude siirata vereloome ravina täiskasvanud patsientidel, kõrge riskiga.

Evrópusambandið - eistneska - EMA (European Medicines Agency)

biogen idec ltd - daklüsumab - hulgiskleroos - immunosupressandid - zinbryta on näidustatud täiskasvanud patsientidel hulgiskleroosi retsidiivsete vormide (rms).

Evrópusambandið - eistneska - 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.

Evrópusambandið - eistneska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - dasatiniib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastilised ained - sprycel on näidustatud ravi pediaatrilised patsiendid:äsja diagnoositud philadelphia-kromosoom-positiivse kroonilise müeloidse leukeemia kroonilise faasi (ph+ cml cp) või ph+ cml cp resistentsed või talumatus eelneva ravi (sh imatinib. äsja diagnoositud ph+ ägeda lümfoblastilise leukeemia (all) kombinatsioonis keemiaraviga. sprycel on näidustatud ravi täiskasvanud patsientidel, kellel on:äsja diagnoositud philadelphia-kromosoom-positiivse (ph+) kroonilise müeloidse leukeemia (cml) kroonilise faasi;krooniline, kiirendatud või lööklaine faasis cml, mille resistentsus või talumatus eelneva ravi (sh imatinib mesilate;ph+ ägeda lümfoblastilise leukeemia (all) ja lümfisüsteemi lööklaine cml, mille resistentsus või talumatus eelneva ravi. sprycel on näidustatud ravi pediaatrilised patsiendid:äsja diagnoositud ph+ cml krooniline faas (ph+ cml-cp) või ph+ cml-cp resistentsed või talumatus eelneva ravi (sh imatinib.