Европейски съюз - български - EMA (European Medicines Agency)

immedica pharma ab - глицерол фенилбутират - Нарушения на цикъла на уреята, вродено - Други стомашно-чревния тракт и обмяната на веществата средства, - ravicti е показан за употреба като допълнителна терапия за лечение на хронично болните урея цикъл нарушения (ucds), включително и недостатъци карбамоильную фосфат-синтазы-аз (sp), орнитин carbamoyltransferase (uts / пяо), argininosuccinate синтетазы (r), argininosuccinate ЛиАЗы (АСЛ), аргиназы аз (арг) и орнитин translocase дефицит hyperornithinaemia-hyperammonaemia homocitrullinuria синдром (ННН), които не могат да бъдат управлявани с храната протеин, ограничаване и/или аминокислотных добавки на мира. ravicti трябва да се използва с ограничение на протеини и, в някои случаи, хранителни добавки (e. , есенциални аминокиселини, аргинин, цитрулин, белтъчини без калории добавки).

Европейски съюз - български - EMA (European Medicines Agency)

pierre fabre medicament - tabelecleucel - lymphoproliferative disorders - ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory epstein-barr virus positive post-transplant lymphoproliferative disease (ebv+ ptld) who have received at least one prior therapy. for solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

Европейски съюз - български - EMA (European Medicines Agency)

novartis europharm limited - ribociclib сукцинат - Неоплазми на гърдата - Антинеопластични средства - kisqali е показан за лечение на жени с хормон-рецептор (ч)‑положителен, хорско эпидермическое приемащото устройство 2 фактор на растежа (her2)‑отрицателен локално-напреднал или метастазирал рак на гърдата в комбинация с инхибитор на ароматаза или фулвестрант като източник на ендокринната терапия се основава, или в жени, които са получили до заместителна терапия. В пре‑ или менопауза, ендокринната терапия да се комбинира с lhrh лутеинизиращ хормон освобождаващ хормон (lhrh) агонист.

Европейски съюз - български - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - Имуносупресори - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Европейски съюз - български - EMA (European Medicines Agency)

adienne s.r.l. s.u. - melphalan hydrochloride - multiple myeloma; hodgkin disease; lymphoma, non-hodgkin; precursor cell lymphoblastic leukemia-lymphoma; leukemia, myeloid, acute; neuroblastoma; ovarian neoplasms; hematopoietic stem cell transplantation - Антинеопластични средства - high-dose of phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (hodgkin, non-hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma. phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (ric) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-hsct) in malignant haematological diseases in adults. phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:myeloablative conditioning (mac) treatment in case of malignant haematological diseasesric treatment in case of non-malignant haematological diseases.

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - Иммуностимуляторы, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Европейски съюз - български - EMA (European Medicines Agency)

instituto grifols s.a. - Имуноглобулин нормален човек - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - Имунни серуми и имуноглобулини - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Европейски съюз - български - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - belatacept - graft rejection; kidney transplantation - Имуносупресори - nulojix, in combination with corticosteroids and a mycophenolic acid (mpa), is indicated for prophylaxis of graft rejection in adult recipients of a renal transplant.

Европейски съюз - български - EMA (European Medicines Agency)

molmed spa - Алогенни Т клетки, генетично модифициран с ретровирусни вектор кодиране за пресечен форма на човешка нисък афинитет нерв растежен фактор рецептор (Δlngfr) и херпес симплекс вирус тимидин киназа (hsv-tk mut2) - hematopoietic stem cell transplantation; graft vs host disease - Антинеопластични средства - zalmoxis е посочено като комбинирана лечение в haploidentical хематопоетична трансплантация на стволови клетки (hsct) на възрастни пациенти с високорискови хематологични неоплазии.

Европейски съюз - български - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - азацитидин - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - Антинеопластични средства - vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with: intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification. vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for hsct with aml with >30% marrow blasts according to the who classification.