Evropska unija - slovenščina - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited  - pazopanib - karcinom, ledvična celica - antineoplastična sredstva - ledvična-cell carcinoma (rkc)votrient je navedeno v odraslih za prvo linijo zdravljenja naprednih ledvic-cell carcinoma (rkc) in pri bolnikih, ki so prejeli pred citokin terapije za napredno bolezni. mehka tkiva sarkom (sts)votrient je indiciran za zdravljenje odraslih bolnikov s selektivno podtipov naprednih mehka tkiva sarkom (sts), ki jih prejeli v pred kemoterapijo za metastatskim bolezni ali ki so napredovali v roku 12 mesecev po (neo)adjuvant therapy. učinkovitost in varnost so le bile ustanovljene v nekaterih sts tumorja, histološki podtipov.

Evropska unija - slovenščina - EMA (European Medicines Agency)

les laboratoires servier - pixantrone dimaleate - limfom, non-hodgkin - antineoplastična sredstva - zdravilo pixuvri je indicirano kot monoterapija za zdravljenje odraslih bolnikov z multiplo relapsnimi ali neodzivnimi agresivnimi limfomi brez hodgkinov b celic (nhl). prednost piksantona pri bolnikih, ki se uporabljajo kot pete ali večje kemoterapije pri bolnikih, ki so odporni na zadnjo terapijo.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastična sredstva - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. 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 (see sections 4. 4 in 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab 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. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab 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 (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab 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%.

Evropska unija - slovenščina - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - karcinom, pljučni pljuč - druga zdravila z delovanjem na novotvorbe agenti, protein kinaza inhibitorji - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

janssen-cilag international nv - bortezomib - multiple myeloma - antineoplastična sredstva - velcade kot monoterapijo ali v kombinaciji z interferonom liposomski doksorubicinijev ali deksametazon je indiciran za zdravljenje odraslih bolnikov s postopno multipli mielom, ki so prejeli vsaj 1 predhodno terapijo in ki so že bili ali so neprimerna za presaditve krvotvornih matičnih celic. velcade v kombinaciji z melphalan in prednizon je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih več plazmocitom, ki ne izpolnjujejo pogojev za visok odmerek kemoterapijo z haematopoietic stem cell presaditev. velcade v kombinaciji z dexamethasone, ali z dexamethasone in thalidomide, je primerna za indukcijsko zdravljenje odraslih bolnikov s predhodno nezdravljenih več plazmocitom, ki so upravičeni za visok odmerek kemoterapijo z haematopoietic stem cell presaditev. velcade v kombinaciji z rituksimabom, ciklofosfamid, doxorubicin in prednizon je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih plašč limfom celic, ki so neprimerni za haematopoietic stem cell presaditev.

Evropska unija - slovenščina - EMA (European Medicines Agency)

les laboratoires servier - ivabradinijev klorid - angina pectoris; heart failure - srčna terapija - simptomatsko zdravljenje kronične stabilne angine pektoris ivabradine je indicirano za simptomatsko zdravljenje kronične stabilne angine pektoris pri koronarne bolezni odraslih s običajen sinusni ritem in srčni utrip ≥ 70 bpm. ivabradine is indicated :in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. zdravljenje kroničnega srčnega popuščanja ivabradine navedena v kronično srčno popuščanje nyha ii do iv razreda z sistolični disfunkcija, pri bolnikih v sinusni ritem in katerih srčni utrip je ≥ 75 bpm, v kombinaciji s standardno zdravljenje, vključno z zdravljenjem s beta-blocker ali kdaj je terapija beta-blocker kontraindiciran ali ne prenaša.

Evropska unija - slovenščina - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - idebenon - optična atrofija, naslednica, leber - drugi psychostimulants in nootropics, psychoanaleptics, - zdravilo raxone je indicirano za zdravljenje motenj vida pri mladostnikih in odraslih bolnikih z leberjevo dedno optično nevropatijo (lhon).

Evropska unija - slovenščina - EMA (European Medicines Agency)

viiv healthcare bv - fosamprenavir kalcij - okužbe z virusom hiv - antivirusi za sistemsko uporabo - telzir v kombinaciji z nizkim odmerkom ritonavirja je indicirano za zdravljenje human-immunodeficiency-virus-type-1-infected odrasli, mladostniki in otroci, šest let in več v kombinaciji z drugimi protiretrovirusna zdravila. v zmerno protiretrovirusnimi-izkušeni odrasli, telzir v kombinaciji z nizkim odmerkom ritonavir ni bilo prikazano, da so enako učinkoviti kot lopinavir / ritonavir. ni primerjalne študije so bile izvedene pri otrocih ali mladostnikih. v močno pretreated bolnikov, uporaba telzir v kombinaciji z nizkim odmerkom ritonavir ni bila dovolj raziskana. v protease-inhibitor-izkušeni bolniki, izbira telzir, ki mora temeljiti na posameznih virusnih odpornost testiranje in zdravljenje zgodovina.

Evropska unija - slovenščina - EMA (European Medicines Agency)

actavis group ptc ehf - topotekan - uterine cervical neoplasms; small cell lung carcinoma - antineoplastična sredstva - monoterapija z topotekanom je indicirana za zdravljenje bolnikov z relapsom malih celic pljučnega raka [sclc], pri katerih se ponovno zdravljenje z režimom prve linije ne šteje za primerno. topotecan v kombinaciji z cisplatin je indicirano za bolnike z karcinom materničnega vratu periodično po radioterapija in za bolnike z stadiju ivb bolezni. bolniki s predhodno izpostavljenosti cisplatin zahtevajo trajno zdravljenje prosti interval, da se upraviči zdravljenje s kombinacijo.