Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - bevacizumabas - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antinavikiniai vaistai - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. daugiau informacijos apie žmogaus epidermio augimo faktoriaus receptorių 2 (her2) būklę rasite 5 skyriuje. vegzelma in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with vegzelma in combination with capecitabine. daugiau informacijos apie her2 statusą rasite 5 skyriuje. vegzelma, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. vegzelma, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. vegzelma, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - daugybinė mieloma - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. kartu su bortezomib, talidomidas ir dexamethasone gydyti suaugusiems pacientams su naujai diagnozuota, daugybine mieloma, kurie turi teisę autologinių kamieninių ląstelių transplantacijos. kartu su lenalidomide ir dexamethasone, ar bortezomib ir dexamethasone, gydyti suaugusiems pacientams, sergantiems daugybine mieloma, kurie gavo bent vieną prieš terapija. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. kaip monotherapy gydyti suaugusiems pacientams, sergantiems atsinaujino ir ugniai mieloma, kurių prieš terapija buvo proteasome inhibitorius ir imunomoduliacinis agentas ir kurie parodė, ligos progresavimo paskutinę terapija. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioedema, paveldima - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemofilija b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent 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. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

pharming group n.v. - rekombinantinis žmogaus c1-inhibitorius - angioedema, paveldima - drugs used in hereditary angioedema, other hematological agents - ruconest skiriamas ūminių angioneurozinės edemos priepuolių gydymui suaugusiems žmonėms, sergantiems paveldima angioneurozine edema (hae) dėl c1 esterazės inhibitoriaus trūkumo.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

amgen europe b.v. - etelcalcetid hydrochloride - hiperparatiroidizmas, antrinis - anti-parathyroid agents, calcium homeostasis - parsabiv skiriamas antrinio hiperparatiroidizmo (shpt) gydymui suaugusiems pacientams, sergantiems lėtinės inkstų ligos (ckd) hemodializės terapija.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

advanced accelerator applications - l-arginine hydrochloride, l-lysine hydrochloride - radiacinės traumų - detoxifying agents for antineoplastic treatment - lysakare yra nurodyta sumažinti inkstų spinduliuotės poveikio metu peptidas-receptorių radionuklidų terapija (prrt) su lutetium (177lu) oxodotreotide suaugusiems.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin meglumine - bendrijos įsigyjamos infekcijos - antibacterials sisteminio naudojimo, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 ir 5. reikėtų atsižvelgti į oficialius nurodymus, kaip tinkamai naudoti antibakterinių veiksnių.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

alfasigma s.p.a. - metiltioninio chlorido - colorectal neoplasms; colonoscopy - other diagnostic agents - lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.