Nyxthracis (previously Obiltoxaximab SFL) Eiropas Savienība - bulgāru - EMA (European Medicines Agency)

nyxthracis (previously obiltoxaximab sfl)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - Имунни серуми и имуноглобулини - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.

Adakveo Eiropas Savienība - bulgāru - EMA (European Medicines Agency)

adakveo

novartis europharm limited - crizanlizumab - Анемия, сърповидна клетка - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.

Arikayce liposomal Eiropas Savienība - bulgāru - EMA (European Medicines Agency)

arikayce liposomal

insmed netherlands b.v. - amikacin sulfate - Инфекции на дихателните пътища - Антибактериални средства за подаване на заявления, - arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (ntm) lung infections caused by mycobacterium avium complex (mac) in adults with limited treatment options who do not have cystic fibrosis.

Elzonris Eiropas Savienība - bulgāru - EMA (European Medicines Agency)

elzonris

stemline therapeutics b.v. - tagraxofusp - lymphoma - Антинеопластични средства - elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (bpdcn).

Libmeldy Eiropas Savienība - bulgāru - EMA (European Medicines Agency)

libmeldy

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - Други лекарства в нервната система - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Orladeyo Eiropas Savienība - bulgāru - EMA (European Medicines Agency)

orladeyo

biocryst ireland limited - berotralstat dihydrochloride - Ангиоедем, наследствено - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Pemazyre Eiropas Savienība - bulgāru - EMA (European Medicines Agency)

pemazyre

incyte biosciences distribution b.v. - pemigatinib - cholangiocarcinoma - Антинеопластични средства - pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.

Sogroya Eiropas Savienība - bulgāru - EMA (European Medicines Agency)

sogroya

novo nordisk a/s - somapacitan - Растеж - Хипофизни и хипоталамични хормони и аналози - sogroya is indicated for the replacement of endogenous growth hormone (gh) in children  aged 3  years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric ghd), and in adults with growth hormone deficiency (adult ghd).

Enspryng Eiropas Savienība - bulgāru - EMA (European Medicines Agency)

enspryng

roche registration gmbh - satralizumab - neuromyelitis optica - Имуносупресори - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Minjuvi Eiropas Savienība - bulgāru - EMA (European Medicines Agency)

minjuvi

incyte biosciences distribution b.v. - tafasitamab - lymphoma, large b-cell, diffuse - Антинеопластични средства - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).