Europos Sąjunga - lietuvių - 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

gilead sciences ireland uc - cobicistat - Živ infekcijos - antivirusiniai vaistai sisteminiam naudojimui - tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (hiv-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

teva generics b.v - zoledrono rūgšties monohidratas - osteoporosis; osteitis deformans - bisfosfonatai - gydymo osteoporosisin po menopauzės womenin suaugusiųjų menat padidinta rizika, kaulų lūžių, įskaitant tuos, kurie su neseniai mažos traumos šlaunikaulio lūžis. gydymo osteoporozės, susijusios su ilgalaikio sisteminio gliukokortikoidų therapyin po menopauzės womenin suaugusiųjų menat, padidėja rizika lūžis. gydymo paget liga kaulų suaugusiems.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

teva b.v. - zoledrono rūgštis - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - narkotikai kaulų ligų gydymui - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture including those with a recent low-trauma hip fracture. treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: , in post-menopausal women;, in men; , at increased risk of fracture. gydymo paget liga kaulų suaugusiems.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

biotest pharma gmbh - žmogaus hepatito b imunoglobulinas - immunization, passive; hepatitis b; liver transplantation - imuninės serumai ir imunoglobulinai, - hepatito b viruso (hbv) pakartotinės infekcijos profilaktika hbsag ir hbv-dnr neigiamiems suaugusiems pacientams mažiausiai vieną savaitę po kepenų transplantacijos dėl hepatito b sukelto kepenų nepakankamumo. hbv-dnr neigiama būsena turi būti patvirtinta per pastaruosius 3 mėnesius iki olt. prieš pradedant gydymą, pacientai turi būti hbsag neigiami. kartu naudoti tinkamą virostatic atstovai turėtų būti laikomas standartas hepatito b pakartotinai infekcijos profilaktika.

Lietuva - lietuvių - SMCA (Valstybinė vaistų kontrolės tarnyba)

lex ano, uab - levonorgestrelis - vartojimo į gimdos ertmę sistema - 20 µg/24 val.; 20 µg/24 val - plastic iud with progestogen

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

janssen-cilag international nv - darunaviras - Živ infekcijos - antivirusiniai vaistai sisteminiam naudojimui - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriparatide - osteoporozė - kalcio homeostazė - sondelbay is indicated in adults. osteoporozės po menopauzės moterims, ir vyrams, kuriems padidėjusi kaulų lūžių rizika. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. gydymo osteoporozės susijusi su ilgalaikis sisteminis gliukokortikoidų terapija moterims ir vyrams padidėjusi rizika lūžis.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

n.v. organon - colecalciferol, alendronic acid (as sodium trihydrate) - osteoporozė, po menopauzės - narkotikai kaulų ligų gydymui - po menopauzinės osteoporozės gydymas pacientams, kuriems yra vitamino d nepakankamumo rizika. adrovance sumažina stuburo ir šlaunikaulio lūžių.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - ibandrono rūgštis - osteoporozė, po menopauzės - narkotikai kaulų ligų gydymui - gydymo osteoporozės po menopauzės, moterys, padidėja lūžio riziką (žr. skyrių 5. sumažinti riziką slankstelių lūžių buvo įrodytas veiksmingumas dėl šlaunikaulio kaklo lūžių nenustatyta.