Omidria Unjoni Ewropea - Malti - EMA (European Medicines Agency)

omidria

rayner surgical (ireland) limited - ketorolac, phenylephrine - lens implantation, intraocular; pain, postoperative - oftalmoloġiċi - omidria hija indikata f'adulti għall-manteniment ta 'midrijasi intraoperattiva, prevenzjoni ta' miosis intraoperattiva u tnaqqis ta 'uġigħ okulari wara l-operazzjoni akuta f'siringa ta' sostituzzjoni tal-lenti intraokulari.

Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sevelamer carbonate winthrop (previously sevelamer carbonate zentiva)

sanofi b.v. - sevelamer carbonate - hyperphosphatemia; renal dialysis - il-prodotti terapewtiċi l-oħra kollha - sevelamer karbonat tal-winthrop huwa indikat għall-kontroll ta'l-iperfosfatemija fil-pazjenti adulti li qegħdin jirċievu l-emodijalisi jew dijalisi tal-peritonew. sevelamer karbonat tal-winthrop huwa indikat ukoll għall-kontroll ta'l-iperfosfatemija fil-pazjenti adulti b'mard kroniku tal-kliewi mhux fuq dijalisi mal-fosforu fis-serum > 1. 78 mmol / l. sevelamer karbonat tal-winthrop għandu jintuża fi ħdan kuntest ta ' metodu terapewtiku multiplu, li jistgħu jinkludu l-suppliment tal-kalċju, 1,25-dihydroxy vitamin d3 jew wieħed mill-analogi tiegħu biex jikkontrollaw l-iżvilupp tal-marda fl-għadam tal-kliewi.

Tasermity Unjoni Ewropea - Malti - EMA (European Medicines Agency)

tasermity

genzyme europe bv - sevelamer hydrochloride - hyperphosphatemia; renal dialysis - il-prodotti terapewtiċi l-oħra kollha - il-karatteristika hija indikata għall-kontroll ta 'iperfosfatemija f'pazjenti adulti li qed jirċievu emodijalisi jew dijalisi peritoneali. sevelamer hydrochloride għandhom jiġu użati fil-kuntest ta ' multipli terapewtiċi approċċ, li jistgħu jinkludu supplimenti tal-kalċju, dihydroxy 1,25 vitamina d3 jew waħda minn tiegħu analogi biex tikkontrolla l-iżvilupp tal-marda ta ' l-għadam renali.

Renvela Unjoni Ewropea - Malti - EMA (European Medicines Agency)

renvela

sanofi b.v. - sevelamer carbonate - hyperphosphatemia; renal dialysis - il-prodotti terapewtiċi l-oħra kollha - renvela huwa indikat għall-kontroll ta 'iperfosfatemija f'pazjenti adulti li qed jirċievu emodijalisi jew dijalisi peritoneali. renvela huwa wkoll indikat għall-kontroll ta'l-iperfosfatemija fil-pazjenti adulti b'mard kroniku tal-kliewi mhux fuq dijalisi mal-fosforu fis-serum ≥ 1. 78 mmol/l. renvela għandu jintuża fi ħdan kuntest ta ' metodu terapewtiku multiplu, li jistgħu jinkludu l-suppliment tal-kalċju, 1,25-dihydroxy vitamin d3 jew wieħed mill-analogi tiegħu biex jikkontrollaw l-iżvilupp tal-marda fl-għadam tal-kliewi.

Renagel Unjoni Ewropea - Malti - EMA (European Medicines Agency)

renagel

sanofi b.v. - sevelamer - renal dialysis; hyperphosphatemia - il-prodotti terapewtiċi l-oħra kollha - renagel is indicated for the control of hyperphosphataemia in adult patients receiving  haemodialysis or peritoneal dialysis. renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy vitamin d3 or one of its analogues to control the development of renal bone disease.

Comirnaty Unjoni Ewropea - Malti - EMA (European Medicines Agency)

comirnaty

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 - vaċċini - 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. l-użu ta ' dan il-vaċċin għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Fexeric Unjoni Ewropea - Malti - EMA (European Medicines Agency)

fexeric

akebia europe limited - kumpless ta 'koordinazzjoni taċ-ċitrat ferriku - hyperphosphatemia; renal dialysis - drogi għat-trattament ta 'iperkalimja u iperfosfatemija - fexeric huwa indikat għall-kontroll ta 'iperfosfatemija f'pazjenti adulti b'mard kroniku tal-kliewi (ckd).

Suvaxyn Circo+MH RTU Unjoni Ewropea - Malti - EMA (European Medicines Agency)

suvaxyn circo+mh rtu

zoetis belgium sa - inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 orf2 protein, inactivated mycoplasma hyopneumoniae, strain p-5722-3 - virali inattivati u l-vaċċini batterjali inattivati - majjali - għall-immunizzazzjoni attiva tal-ħnieżer mill-età ta ' 3 ġimgħat kontra l-virus porcine circovirus tip 2 (pcv2) biex titnaqqas it-tagħbija virali fid-demm u fit-tessuti linfojde u l-ippurgar jixħtu kkawżati mill-infezzjoni bil-pcv2. għal immunizzazzjoni attiva ta 'majjali fuq l-età ta' 3 ġimgħat kontra mycoplasma hyopneumoniae biex jitnaqqsu l-leżjonijiet tal-pulmun ikkawżati minn infezzjoni b'm. hyopneumoniae.

Lymphoseek Unjoni Ewropea - Malti - EMA (European Medicines Agency)

lymphoseek

navidea biopharmaceuticals europe ltd. - tilmanocept - radjonuklidi imaging - jiġu identifikati t-tumuri, dijanjostiċi radjufarmaċewtiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. radjutikkettat lymphoseek huwa indikat għall-immaġini u waqt l-operazzjoni sejbien ta'sentinella nodi limfatiċi tqattir primarju tat-tumur fil-pazjenti adulti bil-kanċer tas-sider, melanoma, jew lokalizzata karċinoma b'ċelloli squamous tal-kavità orali. estern tal-immaġini u waqt l-operazzjoni ta'evalwazzjoni jista'jsir bl-użu tal-gamma-iskoperta tal-apparat.

Lynparza Unjoni Ewropea - Malti - EMA (European Medicines Agency)

lynparza

astrazeneca ab - olaparib - neoplażmi fl-ovarji - aġenti antineoplastiċi - ta 'l-ovarji cancerlynparza huwa indikat bħala monoterapija għall -: l-manteniment tat-trattament ta' pazjenti adulti b'avvanzat (medjevali stadji iii u iv) brca1/2 mutat (linja ġerminali u/jew somatiċi) ta 'grad għoli ta' l-epitilju ta 'l-ovarji, tubu fallopjan jew primarja peritoneali-kanċer li huma fir-rispons (sħiħa jew parzjali) wara t-tlestija ta' l-ewwel linja bbażata fuq il-platinu ' kimoterapija. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 u 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. il-pazjenti għandu jkollhom qabel kienu kkurati bil-anthracycline u taxane fil - (neo)adjuvant jew metastatiku-istabbiliment sakemm il-pazjenti li ma kienux tajbin għal dawn it-trattamenti (ara sezzjoni 5. pazjenti bl-ormon tat-riċettur (hr)-kanċer tas-sider posittiv għandu wkoll għamlu progress fuq jew wara qabel l-terapija endokrinali, jew jiġu kkunsidrati bħala mhux adattati għal terapija endokrinali. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.