Uniunea Europeană -
română -
EMA (European Medicines Agency)
heplisav b
dynavax gmbh - hepatita b antigen de suprafață - hepatita b - vaccinuri - heplisav b is indicated for the active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes of hepatitis b virus in adults 18 years of age and older. the use of heplisav b should be in accordance with official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with heplisav b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.
România -
română -
ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)
veyann 0,02 mg/3 mg
laboratorios leon farma, s.a. - spania - combinatii (etinilestradiolum+drospirenonum) - compr. film. - 0,02mg/3mg - contraceptive hormonale pentru uz sistemic progesteroni si estrogeni combinatii fixe
Uniunea Europeană -
română -
EMA (European Medicines Agency)
vaxneuvance
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)
covid-19 vaccine (inactivated, adjuvanted) valneva
valneva austria gmbh - covid-19 vaccine (inactivated, adjuvanted, adsorbed) - covid-19 virus infection - vaccinuri - covid-19 vaccine (inactivated, adjuvanted) valneva is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 to 50 years of age. the use of this vaccine should be in accordance with official recommendations.
Uniunea Europeană -
română -
EMA (European Medicines Agency)
tyenne
fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - imunosupresoare - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.
Uniunea Europeană -
română -
EMA (European Medicines Agency)
cimzia
ucb pharma sa - certolizumab pegol - crohn boala - imunosupresoare - cimzia, in combination with methotrexate (mtx), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (ra) in adult patients when the response to disease-modifying antirheumatic drugs (dmard) including methotrexate, has been inadequate. cimzia poate fi administrat în monoterapie în caz de intoleranță la metotrexat sau atunci când tratamentul continuu cu metotrexat este inadecvat. cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.