Wakix União Europeia - lituano - EMA (European Medicines Agency)

wakix

bioprojet pharma - pitolisant - narkolepsija - kiti nervų sistemos vaistai - wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.

Zydelig União Europeia - lituano - EMA (European Medicines Agency)

zydelig

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.

Venclyxto União Europeia - lituano - EMA (European Medicines Agency)

venclyxto

abbvie deutschland gmbh co. kg - venetoclax - leukemija, limfocitinė, lėtinė, b-ląstelė - antinavikiniai vaistai - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Orkambi União Europeia - lituano - EMA (European Medicines Agency)

orkambi

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cistinė fibrozė - kiti kvėpavimo sistemos produktai - orkambi tabletės yra nurodyta gydyti cistine fibroze (cf) pacientams nuo 6 metų ir vyresni, kurie yra homozigotiniam už f508del mutacija cftr geno. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Riluzole Zentiva União Europeia - lituano - EMA (European Medicines Agency)

riluzole zentiva

zentiva k.s. - riluzolo - amiotrofinė šoninė sklerozė - kiti nervų sistemos vaistai - riluzole zentiva yra skirtas prailginti amyotrofinę šoninę sklerozę (als) sergantiems pacientams gyvenimo ar laiko prailginimą iki mechaninės ventiliacijos.. clinical trials have demonstrated that riluzole zentiva extends survival for patients with als. išgyvenimo trukmė buvo apibrėžta kaip pacientams, kurie buvo gyvas, ne intubated. mechaninio vėdinimo ir tracheotomy-nemokamai. nėra įrodymų, kad riluzolo zentiva daro gydomąjį poveikį, variklio funkcija, plaučių funkcija, trūkčiojimams, raumenų jėgą ir motorinių simptomų. riluzolo zentiva nebuvo įrodyta, kad būti veiksmingos vėlesniuose etapuose als. saugumo ir veiksmingumo riluzolo zentiva tik studijavo als. todėl, riluzolo zentiva neturėtų būti naudojama pacientams, sergantiems bet kokia kita forma, variklis-neurone ligos.

Triumeq União Europeia - lituano - EMA (European Medicines Agency)

triumeq

viiv healthcare b.v. - dolutegravir sodium, lamivudine, abacavir (as sulfate) - Živ infekcijos - antivirusiniai vaistai sisteminiam naudojimui - triumeq is indicated for the treatment of human immunodeficiency virus (hiv) infected adults,  adolescents and children  weighing at least 25 kg who are antiretroviral treatment-naïve or are infected with hiv without documented or clinically suspected resistance to any of the three antiretroviral agents in triumeq.

Tagrisso União Europeia - lituano - EMA (European Medicines Agency)

tagrisso

astrazeneca ab - osimertinib mesilate - karcinoma, nesmulkiųjų ląstelių skausmas - kiti antinavikiniai vaistai agentai, baltymų kinazės inhibitoriai - 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.

Vemlidy União Europeia - lituano - EMA (European Medicines Agency)

vemlidy

gilead sciences ireland uc - tenofoviro alafenamido fumaratas - hepatitas b - antivirusiniai vaistai sisteminiam naudojimui - vemlidy is indicated for the treatment of chronic hepatitis b (chb) in adults and paediatric patients 6 years of age and older weighing at least 25 kg (see section 5.

Olumiant União Europeia - lituano - EMA (European Medicines Agency)

olumiant

eli lilly nederland b.v. - baricitinib - artritas, reumatas - imunosupresantai - rheumatoid arthritisbaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). olumianetą galima vartoti kaip monoterapiją arba kartu su metotreksatu. atopic dermatitisolumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. alopecia areatabaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5. juvenile idiopathic arthritisbaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic dmards:- polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [rf+] or negative [rf-], extended oligoarticular),- enthesitis related arthritis, and- juvenile psoriatic arthritis. baricitinib may be used as monotherapy or in combination with methotrexate.

Sovaldi União Europeia - lituano - EMA (European Medicines Agency)

sovaldi

gilead sciences ireland uc - sofosbuvir - hepatitas c, lėtinis - antivirusiniai vaistai sisteminiam naudojimui - sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 ir 5. hepatito c viruso (hcv) genotipo specifinė veikla, žr. skirsnius 4. 4 ir 5. sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adults and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 ir 5. hepatito c viruso (hcv) genotipo specifinė veikla, žr. skirsnius 4. 4 ir 5.