Praluent Uniunea Europeană - română - EMA (European Medicines Agency)

praluent

sanofi winthrop industrie - alirocumab - dislipidemii - agenți de modificare a lipidelor - hipercolesterolemie primară și mixte dyslipidaemiapraluent este indicat la pacienții adulți cu hipercolesterolemie primară (familială heterozigotă și non-familială) sau dislipidemiei mixte, ca adjuvant la dietă:în asociere cu o statină sau statine cu alte hipolipemiant terapii la pacienții care nu pot ajunge ldl-c goluri cu doza maximă tolerată de statină sau,singur sau în combinație cu alte tratamente hipolipemiante la pacienții care sunt statină la lactoza, sau pentru care o statină este contraindicat. stabilit boli cardiovasculare aterosclerotice praluent este indicat la adulți cu înființată boli cardiovasculare aterosclerotice pentru a reduce riscul cardiovascular prin scăderea ldl-c de niveluri, ca adjuvant pentru corectarea altor factori de risc:în combinație cu doza maximă tolerată de statină, cu sau fără alte tratamente hipolipemiante sau,singur sau în combinație cu alte tratamente hipolipemiante la pacienții care sunt statină la lactoza, sau pentru care o statină este contraindicat. pentru rezultatele studiului cu privire la efectele asupra ldl-c, evenimente cardiovasculare și populațiile studiate a se vedea secțiunea 5.

Thyrogen Uniunea Europeană - română - EMA (European Medicines Agency)

thyrogen

sanofi b.v. - alfa-tirotropină - neoplasme tiroidiene - hormoni ai lobului hipofizar anterior și analogii, hipofizari și hipotalamici și analogi de hormoni - thyrogen is indicated for use with serum thyroglobulin (tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (thst). low risk patients with well-differentiated thyroid carcinoma who have undetectable serum tg levels on thst and no rh (recombinant human) tsh-stimulated increase of tg levels may be followed-up by assaying rh tsh-stimulated tg levels. thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mci (1. 1 gbq) to 100 mci (3. 7 gbq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.

Dupixent Uniunea Europeană - română - EMA (European Medicines Agency)

dupixent

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - agenți pentru dermatită, cu excepția corticosteroizilor - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Nexviadyme Uniunea Europeană - română - EMA (European Medicines Agency)

nexviadyme

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).

Xenpozyme Uniunea Europeană - română - EMA (European Medicines Agency)

xenpozyme

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.

Toujeo  SoloStar 300 U/ml soluţie injectabilă în stilou injector (pen) preumplut Republica Moldova - română - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

toujeo solostar 300 u/ml soluţie injectabilă în stilou injector (pen) preumplut

sanofi-aventis deutschland gmbh - insulinum glarginum - soluţie injectabilă în stilou injector (pen) preumplut - 300 u/ml