Uniunea Europeană - română - EMA (European Medicines Agency)

janssen-cilag international nv - rilpivirine - infecții cu hiv - antivirale pentru uz sistemic - rekambys is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (hiv 1) infection in adults who are virologically suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the nnrti and ini class.

Uniunea Europeană - română - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - imunosupresoare - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Uniunea Europeană - română - EMA (European Medicines Agency)

astellas pharma europe b.v. - roxadustat - anemia; kidney failure, chronic - preparate antianemice - evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (ckd).

Uniunea Europeană - română - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - pneumococcal polysaccharide conjugate vaccine (adsorbed) - infecții pneumococice - pneumococcus, purified polysaccharides antigen conjugated - vaxneuvance is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. vaxneuvance is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. vezi secțiunile 4. 4 și 5. 1 pentru informații privind protecția împotriva serotipurilor pneumococice specifice. the use of vaxneuvance should be in accordance with official recommendations.

Uniunea Europeană - română - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - diabetul zaharat, tip 2 - medicamente utilizate în diabet - for adult patients with type 2 diabetes mellitus, sitagliptin sun is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Uniunea Europeană - română - EMA (European Medicines Agency)

astellas pharma europe b.v. - enfortumab vedotin - carcinoma, transitional cell; urologic neoplasms - agenți antineoplazici - padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.

Uniunea Europeană - română - EMA (European Medicines Agency)

sanofi b.v. - avalglucosidase alfa - glicogenul de boală de tip ii - alte medicamente pentru tractul digestiv și metabolism, - nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with pompe disease (acid α-glucosidase deficiency).

Uniunea Europeană - română - EMA (European Medicines Agency)

sanofi b.v. - olipudase alfa - acid sphingomyelinase deficiency (asmd) type a/b or type b - alte medicamente pentru tractul digestiv și metabolism, - xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-central nervous system (cns) manifestations of acid sphingomyelinase deficiency (asmd) in paediatric and adult patients with type a/b or type b.

Uniunea Europeană - română - EMA (European Medicines Agency)

amryt pharmaceuticals dac - dry extract from birch bark (der 5-10 : 1), extraction solvent n-heptane 95% (w/w) - epidermolysis bullosa dystrophica; epidermolysis bullosa, junctional - preparate pentru tratarea rănilor și ulcerelor - treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (eb) in patients 6 months and older.

Uniunea Europeană - română - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - maribavir - infecții cu citomegalovirus - antivirale pentru uz sistemic - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot). trebuie luate în considerare ghidurile oficiale privind utilizarea adecvată de agenți antivirali.