União Europeia - lituano - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antinavikiniai vaistai - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pacientams su egfr ar Šarminiai teigiamas navikas mutacijų, taip pat turėtų būti gautas tikslinis gydymas prieš gaunant keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

União Europeia - lituano - EMA (European Medicines Agency)

baxalta innovations gmbh - susoktokogas alfa - hemofilija a - antihemoraginiai - kraujavimo epizodų gydymas pacientams, kuriems pasireiškė hemofilija, atsiradusi dėl viii faktoriaus antikūnų. obizur yra nurodomas suaugusiesiems.

União Europeia - lituano - EMA (European Medicines Agency)

viatris healthcare limited - tobramycin - cystic fibrosis; respiratory tract infections - antibacterials sisteminio naudojimo, - tobi podhaler skiriamas lėtinės plaučių infekcijos slopinamam gydymui dėl pseudomonas aeruginosa suaugusiems ir 6 metų ir vyresniems vaikams, sergantiems cistine fibroze. Žr. 4 skyrius. 4 ir 5. 1 duomenis apie skirtingų amžiaus grupių duomenis. reikėtų atsižvelgti į oficialius nurodymus, kaip tinkamai naudoti antibakterinių veiksnių.

União Europeia - lituano - EMA (European Medicines Agency)

merck sharp dohme ltd - boceprevir - hepatitas c, lėtinis - antivirusiniai vaistai sisteminiam naudojimui - victrelis yra skiriamas gydyti lėtiniu hepatitu c (lhc) 1 genotipo infekcija, kartu su peginterferonu alfa ir ribavirinu, suaugusiems pacientams su kompensuota kepenų liga, kuriems anksčiau negydytiems arba kuriems nepavyko po ankstesnio gydymo.

União Europeia - lituano - EMA (European Medicines Agency)

servier (ireland) industries ltd - agomelatine - depresijos sutrikimas, majoras - psychoanaleptics, - suaugusiųjų depresijos epizodų gydymas.

União Europeia - lituano - EMA (European Medicines Agency)

les laboratoires servier - agomelatine - depresijos sutrikimas, majoras - psychoanaleptics, - suaugusiųjų depresijos epizodų gydymas.

União Europeia - lituano - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - telmisartan, amlodipine - hipertenzija - renino ir angiotenzino sistemos veikiantys vaistai - gydymo esminių hipertenzija suaugusiems:add-on therapytwynsta yra nurodyta suaugusieji, kurių kraujospūdis nepakankamai kontroliuojamas amlodipine. pakeitimo therapyadult pacientams, kuriems telmisartan ir amlodipine iš atskirų tabletės gali, o ne gauti tabletės twynsta, kurių sudėtyje yra to paties komponento, dozės.

União Europeia - lituano - EMA (European Medicines Agency)

merck sharp & dohme b.v. - elbasvir, grazoprevir - hepatitas c, lėtinis - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 ir 5. hepatito c viruso (hcv) genotipo-konkrečios veiklos, žr. skirsnius 4. 4 ir 5.

União Europeia - lituano - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - idebenonas - optinė atrofija, paveldima, leber - kiti psychostimulants ir nootropics, psychoanaleptics, - raxone skiriamas regėjimo sutrikimo gydymui paaugliams ir suaugusiems pacientams, kuriems yra leberio paveldima optinė neuropatija (lhon).

União Europeia - lituano - EMA (European Medicines Agency)

merck sharp dohme limited - vorapaksaro sulfatas - miokardinis infarktas - antitromboziniai vaistai - zontivityis nurodė sumažinti atherothrombotic įvykių suaugusių pacientų su - istorija miokardo infarktas (mi)bendrai vartojama kartu su acetilsalicilo rūgštimi (asr) ir, jei reikia, klopidogrelio; arba - simptominis periferinių arterijų liga(trinkelĖs), co-vartojama kartu su acetilsalicilo rūgštimi (asr) arba, jei reikia, klopidogrelį.