Unia Europejska - bułgarski - EMA (European Medicines Agency)

mylan ireland limited - финголимод хидрохлорид - Множествена Склероза, Рецидивно-Ремиттирующее - Имуносупресори - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 и 5. 1)orpatients с бързо се развива тежка relapsing начин множествена склероза се определя от 2 или по-тежки рецидиви в рамките на една година, и с 1 или по-гадолиний активизиране на огнища на ядрено-магнитен резонанс на главния мозък или значително увеличаване на натоварването Т2 лезии в сравнение с най-новите ядрено-магнитен резонанс.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

mylan ireland limited - финголимод хидрохлорид - Множествена Склероза, Рецидивно-Ремиттирующее - Имуносупресори - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (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.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

pfizer europe ma eeig - somatrogon - growth and development - НА ХИПОФИЗАТА И ГИПОТАЛАМИЧЕСКИЕ ХОРМОНИ И АНАЛОЗИ - indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

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.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) 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 - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax bivalent original/omicron ba. 1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19. spikevax bivalent original/omicron ba. 4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.  spikevax xbb. 5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older. the use of this vaccine should be in accordance with official recommendations.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - флутиказона фуроат, vilanterol trifenatate - астма - adrenergics и други лекарства за обструктивни заболявания на дихателните пътища - Астма indicationrevinty ellipta е посочено в редовното лечение на бронхиална астма при възрастни и юноши на възраст 12 и повече години, където използването на комбинации на продукта (дълго действащ бета2-агонист и ингаляционных кортикостероиди) са подходящи:пациентите не е адекватно контролирана ингаляционными джи си ес и, ако е необходимо" вдишване, кратко действащ бета2-агонисти. indicationrevinty ХОББ ellipta е показан за симптоматично лечение на възрастни пациенти с хронична обструктивна белодробна болест с ОФВ1.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - Хемоглобинурия, пароксизма - Селективни имуносупресори - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Unia Europejska - bułgarski - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - хепатит В, рекомбинантен повърхностен антиген - hepatitis b; immunization - Ваксини - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. Специфични групи в риск ще бъдат ваксинирани трябва да бъдат определени въз основа на официалните препоръки. Може да се очаква, че хепатит d също така да бъдат предотвратени чрез ваксиниране с hbvaxpro като хепатит d (причинен от агент Делта) не се среща при липса на вируса на хепатит В инфекция. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. Специфични групи в риск ще бъдат ваксинирани трябва да бъдат определени въз основа на официалните препоръки. Може да се очаква, че хепатит d също така да бъдат предотвратени чрез ваксиниране с hbvaxpro като хепатит d (причинен от агент Делта) не се среща при липса на вируса на хепатит В инфекция. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. Може да се очаква, че хепатит d също така ще бъдат предотвратени чрез имунизация с hbvaxpro като хепатит d (причинен от агент Делта) не се среща при липса на вируса на хепатит .