האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

viiv healthcare bv - фозампренавир калций - ХИВ инфекции - Антивирусни средства за системно приложение - Лексива™ в комбинация с ниски дози ритонавир е показан за лечение на human-immunodeficiency-virus-type-1-infected възрастни, юноши и деца от шест години и в комбинация с други антиретровирусните лекарствени продукти. В умерено АРВ-опитните възрастни, Телзир в комбинация с ниска доза ritonavir не е доказано, че е също толкова ефективен, колкото lopinavir / ritonavir. Сравнителни изследвания са провеждани при деца и юноши. В голяма степен предварително третирани пациенти, използването на Телзир в комбинация с ниска доза ritonavir още не са достатъчно проучени. В протеаза-инхибитор-опитни пациенти, избор Телзир трябва да се основава на индивидуална вирусна резистентност тестване и историята на лечение .

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - Кистозна фиброза - Други продукти на дихателната система - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - Антинеопластични средства - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

pfizer europe ma eeig - ritlecitinib tosilate - alopecia areata - Имуносупресори - litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - Кистозна фиброза - Други продукти на дихателната система - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 и 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 и 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

gilead sciences ireland uc - bulevirtide acetate - hepatitis d, chronic - Антивирусни средства за системно приложение - hepcludex is indicated for the treatment of chronic hepatitis delta virus (hdv) infection in plasma (or serum) hdv-rna positive adult patients with compensated liver disease.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - Антинеопластични средства - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

amgen europe bv - sotorasib - Карцином, недребноклетъчен белодроб - Антинеопластични средства - lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (nsclc) with kras g12c mutation and who have progressed after at least one prior line of systemic therapy.

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - ритонавир - ХИВ инфекции - Антивирусни средства за системно приложение - Ритонавир е показан в комбинация с други антиретровирусни средства за лечение на hiv-1-инфектирани пациенти (възрастни и деца на две години и по-големи).

האיחוד האירופי - בולגרית - EMA (European Medicines Agency)

mylan s.a.s - ритонавир - ХИВ инфекции - Антивирусни средства за системно приложение - Ритонавир е показан в комбинация с други антиретровирусни средства за лечение на инфектирани с hiv 1 пациенти (възрастни и деца на 2-годишна възраст и по-големи).