Европейски съюз - български - 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.

Европейски съюз - български - EMA (European Medicines Agency)

pfizer europe ma eeig  - voxelotor - anemia; anemia, hemolytic; anemia, sickle cell - other hematological agents - oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (scd) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.

Европейски съюз - български - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - Левкемия, миелогенна, хронична, bcr-abl положителна - Антинеопластични средства - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

Европейски съюз - български - EMA (European Medicines Agency)

eli lilly nederland b.v. - pirtobrutinib - Лимфом, мантел-клетка - Инхибитори на протеинкиназы - treatment of mantle cell lymphoma (mcl).

Европейски съюз - български - EMA (European Medicines Agency)

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.

Европейски съюз - български - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - Антинеопластични средства - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Европейски съюз - български - EMA (European Medicines Agency)

agios netherlands b.v. - mitapivat sulfate - genetic diseases, inborn; anemia, hemolytic - other hematological agents - pyrukynd is indicated for the treatment of pyruvate kinase deficiency (pk deficiency) in adult patients (see section 4.

Европейски съюз - български - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - мидазолам - епилепсия - психолептици - Лечението е продължително, остри, конвулсивни гърчове при новородени, бебета, деца и юноши (от три месеца преди по-малко от 18 години). buccolam трябва да се използва само на родителите / настойниците, в която пациентът е диагноза епилепсия. За деца от три до шест месеца възраст, лечението трябва да се извършва в условията на болница, където е възможно наблюдение и реанимация оборудване на разположение.

Европейски съюз - български - EMA (European Medicines Agency)

astrazeneca ab - olaparib - Овариални неоплазми - Антинеопластични средства - Яйчниците cancerlynparza включен като монотерапии за:подкрепа на лечение на възрастни пациенти с късни (фиго етапи iii и iv) в гените brca1/2-мутирали (зародышевой линия и/или соматични) высокосортная епител на яйчника, маточната тръба или начална перитонеална рак, които в отговор (пълна или частична) след приключване на първа линия на базата на платина химиотерапия. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 и 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. Пациентите трябва предварително са обработени с антрациклина и таксана в (нео)помощните или метастатический, ако пациентите не са подходящи за тези процедури (виж раздел 5. Пациентите с рецептор хормон (ч)-положителен рак на гърдата трябва също така да развиват или след предварителна хормонална терапия, или се считат за неподходящи за ендокринна терапия. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Европейски съюз - български - EMA (European Medicines Agency)

provepharm sas - метилтионинов хлорид - метхемоглобинемия - Всички други терапевтични продукти - Остра симптоматична терапия на индуцираната от лекарствени и химични продукти метхемоглобинемия. methylthioninium proveblue хлорид е показан за възрастни, деца и юноши (на възраст от 0 до 17 години).