Tysabri Европейски съюз - български - EMA (European Medicines Agency)

tysabri

biogen netherlands b.v. - натализумаб - Множествена склероза - Селективни имуносупресори - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 и 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Spinraza Европейски съюз - български - EMA (European Medicines Agency)

spinraza

biogen netherlands b.v. - nusinersen sodium - Мускулна атрофия, спинална - Други лекарства в нервната система - spinraza е показан за лечение на 5q спинална мускулна атрофия.

Onpattro Европейски съюз - български - EMA (European Medicines Agency)

onpattro

alnylam netherlands b.v. - patisiran натрий - Амилоидоза, Фамилна - Други лекарства в нервната система - onpattro е показан за лечение на наследствени транстиретина-посредничанного амилоидоза (hattr амилоидоза) при възрастни пациенти с 1 етап 2 етап полиневропатия.

GHRYVELIN (previously Macimorelin Aeterna Zentaris) Европейски съюз - български - EMA (European Medicines Agency)

ghryvelin (previously macimorelin aeterna zentaris)

atnahs pharma netherlands b.v. - macimorelin ацетат - Методи На Диагностика, На Ендокринната - macimorelin - Този лекарствен продукт е само за диагностична употреба.  ghryvelin is indicated for the diagnosis of growth hormone deficiency (ghd) in adults.

Zabdeno Европейски съюз - български - EMA (European Medicines Agency)

zabdeno

janssen-cilag international n.v.    - recombinant adenovirus type 26 (ad26) encoding the glycoprotein (gp) of the ebola virus zaire (zebov) mayinga strain - Хеморагична Треска Ебола - Ваксини - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.

Ayvakyt Европейски съюз - български - EMA (European Medicines Agency)

ayvakyt

blueprint medicines (netherlands) b.v. - avapritinib - Стомашно-чревни стромални тумори - Други противоракови лекарства, инхибитори на протеинкиназы - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Arikayce liposomal Европейски съюз - български - 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.

Comirnaty Европейски съюз - български - EMA (European Medicines Agency)

comirnaty

biontech manufacturing gmbh - single-stranded, 5’-capped messenger rna produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - Ваксини - comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty original/omicron ba. 1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19. comirnaty original/omicron ba. 4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty original/omicron ba. 4-5 (1. 5/1. 5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty omicron xbb. 5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty omicron xbb. 5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. Използването на тази ваксина трябва да бъде приложена в съответствие с официалните препоръки.