Bulgaaria - bulgaaria - БАБХ (Българска агенция по безопасност на храните)

Сева Анимал Хелт България ЕООД - pimbendan - дъвчаща таблетка - 10 mg/таблетка - кучета

Bulgaaria - bulgaaria - БАБХ (Българска агенция по безопасност на храните)

Сева Анимал Хелт България ЕООД - pimobendan - дъвчаща таблетка - 5 mg/таблетка - кучета

Euroopa Liit - bulgaaria - EMA (European Medicines Agency)

santen oy - netarsudil - glaucoma, open-angle; ocular hypertension - Офталмологични - Намаляване на повишено вътреочното налягане (ВОН) при възрастни пациенти с първична откритоъгълна глаукома или очна хипертония.

Euroopa Liit - bulgaaria - EMA (European Medicines Agency)

accord healthcare s.l.u. - ривароксабан - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - Антитромботични агенти - Предотвратяване на венозна тромбоемболия (ВТЕ) при възрастни пациенти, подложени на елективна операция за замяна на тазобедрена или колянна става. Лечение на дълбока венозна тромбоза (dvt) и тромбоэмболии белодробната артерия (ТЭЛА) и за превенция на рецидив на дълбока венозна тромбоза и ТЭЛА при възрастни. (see section 4. 4 for haemodynamically unstable pe patients. Лечение на дълбока венозна тромбоза (dvt) и тромбоэмболии белодробната артерия (ТЭЛА) и за превенция на рецидив на дълбока венозна тромбоза и ТЭЛА при възрастни. (see section 4. 4 за гемодинамически нестабилна ТЭЛА пациенти). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Лечение на дълбока венозна тромбоза (dvt) и тромбоэмболии белодробната артерия (ТЭЛА) и за превенция на рецидив на дълбока венозна тромбоза и ТЭЛА при възрастни. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 и 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Лечение на дълбока венозна тромбоза (dvt) и тромбоэмболии белодробната артерия (ТЭЛА) и за превенция на рецидив на дълбока венозна тромбоза и ТЭЛА при възрастни. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Euroopa Liit - bulgaaria - 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.

Euroopa Liit - bulgaaria - EMA (European Medicines Agency)

santen oy - latanoprost, netarsudil mesilate - glaucoma, open-angle; ocular hypertension - Офталмологични - roclanda is indicated for the reduction of elevated intraocular pressure (iop) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient iop reduction.

Euroopa Liit - bulgaaria - EMA (European Medicines Agency)

janssen-cilag international nv - adenovirus type 26 encoding the sars-cov-2 spike glycoprotein (ad26.cov2-s) - covid-19 virus infection - Ваксини - jcovden is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older. Използването на тази ваксина трябва да бъде приложена в съответствие с официалните препоръки.

Euroopa Liit - bulgaaria - EMA (European Medicines Agency)

astrazeneca ab - chadox1-sars-cov-2 - covid-19 virus infection - Ваксини - vaxzevria is indicated for active immunisation to prevent covid 19 caused by sars cov 2, in individuals 18 years of age and older. Използването на тази ваксина трябва да бъде приложена в съответствие с официалните препоръки.

Euroopa Liit - bulgaaria - EMA (European Medicines Agency)

albireo - odevixibat - cholestasis, intrahepatic - Болест и чернодробна терапия - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or older (see sections 4. 4 и 5.

Euroopa Liit - bulgaaria - EMA (European Medicines Agency)

janssen-cilag international n.v.    - ponesimod - Множествена Склероза, Рецидивно-Ремиттирующее - Имуносупресори - ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.