Umoja wa Ulaya - Kibulgaria - EMA (European Medicines Agency)

merck sharp & dohme b.v. - пегинтерферон алфа-2b - Хепатит c, хроничен - Иммуностимуляторы, - adults (tritherapy)pegintron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Моля, консултирайте се с Рибавирин и боцепревир кратки характеристики на продукта (smpcs), когато пегинтрон трябва да се използва в комбинация с тези лекарства. adults (bitherapy and monotherapy)pegintron is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. Пегинтрон в комбинация с рибавирином (bitherapy) е показан за лечение на ХГС-инфекция при възрастни пациенти, по-рано не е получавала лечение, включително и на пациенти с клинично стабилна ХИВ-инфекция и при възрастни пациенти, които не предишно лечение интерфероном Алфа (пегилированным или пегилированным) и рибавирином или комбинирана терапия интерфероном-Алфа под формата на монотерапии. Монотерапия интерфероном, включително пегинтрон, показва предимно при непоносимост или противопоказания към рибавирину. Моля, обърнете се към Смпц рибавирином пегинтрон, когато се използва в комбинация с рибавирином. paediatric population (bitherapy)pegintron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have chc, previously untreated, without liver decompensation, and who are positive for hcv-rna. При вземане на решение да не се отложи лечението до зряла възраст, е важно да се отчете, че комбинираната терапия предизвиква забавяне на растежа, който може да бъде необратим при някои пациенти. Решението трябва да бъде взето на индивидуална основа. Моля, обърнете се към Смпц Рибавирин капсули или перорален разтвор, когато пегинтрон трябва да се използва в комбинация с рибавирином.

Umoja wa Ulaya - Kibulgaria - 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.

Umoja wa Ulaya - Kibulgaria - EMA (European Medicines Agency)

sanofi pasteur - neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid - Менингит, менингококов - Ваксини - menquadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w, and y. the use of this vaccine should be in accordance with available official recommendations.

Umoja wa Ulaya - Kibulgaria - 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.

Umoja wa Ulaya - Kibulgaria - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomide - Множествена склероза - Селективни имуносупресори - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Umoja wa Ulaya - Kibulgaria - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - адалимумаб - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - Имуносупресори - Моля, вижте документа с информация за продукта.

Umoja wa Ulaya - Kibulgaria - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19f - pneumococcal infections; immunization - Ваксини - Активна имунизация срещу инвазивно заболяване и остър отит на средното ухо, причинени от streptococcus pneumoniae при бебета и деца от шест седмици нагоре до пет години на възраст. Вижте раздели 4. 4 и 5. 1 в продуктовата информация за информация за защита срещу специфични пневмококови серотипове. Прилагането на ваксината synflorix трябва да се определя въз основа на официални препоръки, като се вземе предвид влиянието на инвазивни заболявания в различните възрастови групи, както и променливостта на серотип на епидемиологията в различни географски райони.

Umoja wa Ulaya - Kibulgaria - EMA (European Medicines Agency)

samsung bioepis nl b.v. - Экулизумаб - Хемоглобинурия, пароксизма - Имуносупресори - epysqli is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

Umoja wa Ulaya - Kibulgaria - EMA (European Medicines Agency)

gsk vaccines s.r.l. - външна мембрана мехурчета от менингококк група b (щам 98/254 nc), рекомбинантный менингококк група в fhbp на синтеза на белтъци, рекомбинантен менингококк група b нада протеин, рекомбинантный менингококк група в nhba синтеза на протеини - Менингит, менингококов - Менингококови ваксини - Активна имунизация срещу инвазивно заболяване, причинено от щамове neisseria meningitidis серогрупа-В.

Umoja wa Ulaya - Kibulgaria - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), poliovirus (inactivated) (type 1 (mahoney strain), type 2 (mef-1 strain), type 3 (saukett strain)), hepatitis b surface antigen - hepatitis b; tetanus; immunization; whooping cough; poliomyelitis; diphtheria - Ваксини - infanrix penta е показан за първична и бустер ваксинация на кърмачета срещу дифтерия, тетанус, коклюш, хепатит В и полиомиелит.