Европейски съюз - български - EMA (European Medicines Agency)

biomarin international limited - vosoritide - achondroplasia - Лекарства за лечение на костни заболявания - voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Европейски съюз - български - EMA (European Medicines Agency)

eigerbio europe limited - lonafarnib - progeria; laminopathies - Други стомашно-чревния тракт и обмяната на веществата средства, - zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of hutchinson-gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous lmna mutation with progerin-like protein accumulation or a homozygous or compound heterozygous zmpste24 mutation.

Европейски съюз - български - EMA (European Medicines Agency)

ptc therapeutics international limited - eladocagene exuparvovec - Аминокиселинен метаболизъм, вродени грешки - enzymes, other alimentary tract and metabolism products - upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic l amino acid decarboxylase (aadc) deficiency with a severe phenotype (see section 5.

Европейски съюз - български - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - pegunigalsidase alfa - Фабри болест - Други стомашно-чревния тракт и обмяната на веществата средства, - elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of fabry disease (deficiency of alpha-galactosidase).

Европейски съюз - български - EMA (European Medicines Agency)

nova laboratories ireland limited - спиронолактон - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 и 5.