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

ecalta

pfizer europe ma eeig - anidulafungin - kandidjasi - antimikotiċi għal użu sistemiku - trattament ta ' kandidjasi invażiva f'pazjenti adulti u pedjatriċi bejn 1 xahar sa < 18-il sena.

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

ibrance

pfizer europe ma eeig  - palbociclib - neoplażmi tas-sider - aġenti antineoplastiċi - ibrance huwa indikat għall-kura ta 'l-ormon tat-riċettur (hr) pożittiv, tal-bniedem tar-riċettur tal-fattur tat-tkabbir epidermali 2 (her2) negattivi lokalment avvanzata jew metastatika tal-kanċer tas-sider:f'kumbinazzjoni ma' inibitur aromatase;flimkien ma ' fulvestrant f'nisa li kienu rċevew qabel terapija endokrinali. fil - pre- jew perimenopausal-nisa, l-endokrinali it-terapija għandha tingħata flimkien ma ' ormon luteinizing releasing hormone (lhrh) agonist.

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

jardiance

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - drogi użati fid-dijabete - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 u 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Levetiracetam Hospira Unjoni Ewropea - Malti - EMA (European Medicines Agency)

levetiracetam hospira

pfizer europe ma eeig - levetiracetam - epilessija - anti-epilettiċi, - levetiracetam hospira huwa indikat bħala monotherapy fit-trattament ta ' b'sekwestru parzjali l-iskoppjar bi jew mingħajr ġeneralizzazzjoni sekondarju fl-adulti u adolexxenti minn 16-il sena ta ' l-età ma ġodda djanjostikat epilessija. levetiracetam hospira huwa indikat bħala aġġuntiva therapyin-trattament ta'aċċessjonijiet tat-tip parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja f'adulti, adolexxenti u tfal minn 4 snin b'epilessija. fit-trattament ta ' aċċessjonijiet mijokloniċi f'adulti u addoloxxenti minn 12 il-sena b'epilessija mijoklonika tal-minorenni. fit-trattament tal-seizures tonic-clonic ġeneralizzati fl-adulti u addoloxxenti minn 12 il-sena b'epilessija Ġeneralizzata idjopatika. levetiracetam hospira-konċentrat huwa alternattiva għal pazjenti meta l-għoti mill-ħalq huwa temporanjament mhux possibbli.

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

nimenrix

pfizer europe ma eeig - neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid - meninġite, meningokokkali - vaċċini - nimenrix huwa indikat għall-immunizzazzjoni attiva ta 'individwi mill-età ta' 6 ġimgħat kontra mard invażiv meningokokkali kkawżat minn neisseria meningitidis grupp a, c, w-135, u y.

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

nivestim

pfizer europe ma eeig  - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulanti, - filgrastim huwa indikat għall-tnaqqis fit-tul tal-neutropenia u l-inċidenza tal-marda bid-deni neutropenia fil-pazjenti trattati ma chemotherapy ċitotossiċi stabbiliti għall-malignancy (bl-eċċezzjoni tal-lewċemja myeloid kronika u myelodysplastic sindromi) u għat-tnaqqis fit-tul tal-neutropenia fil-pazjenti sottoposti għal terapija myeloablative segwit mill-mudullun trapjant meqjusa li huma f'riskju akbar ta ' neutropenia ħorox imtawla. is-sigurtà u l-effikaċja ta 'filgrastim huma simili fl-adulti u fit-tfal li qed jirċievu kimoterapija ċitotossika. filgrastim huwa indikat għall-mobilizzazzjoni ta ' ċelluli proġenituri tad-demm (pbpcs). f'pazjenti, tfal jew adulti, b'severa konġenitali, ċiklika, jew newtropenja idjopatika bl-għadd assolut ta 'newtrofili (anc) ta' ≤0. 5 x 109/l, u storja ta severi jew infezzjonijiet rikorrenti, l-għoti fit-tul ta 'filgrastim hu indikat biex iżid l-għadd tan-newtrofili u biex inaqqas l-inċidenza u t-tul ta' l-infezzjoni avvenimenti relatati mal-. filgrastim huwa indikat għall-kura ta ' newtropenja persistenti (anc ≤1. 0 x 109 / l) f'pazjenti b'infezzjoni avvanzata ta 'l-hiv, sabiex jitnaqqas ir-riskju ta' infezzjonijiet batteriċi meta għażliet oħra biex tiġi amministrata n-newtropenija mhumiex xierqa.

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

ofev

boehringer ingelheim international gmbh - nintedanib - fibrożi pulmonari idjopatika - aġenti antineoplastiċi - ofev huwa indikat fl-adulti għat-trattament tal-fibrożi pulmonari idjopatika (ipf).

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

zavicefta

pfizer ireland pharmaceuticals - avibactam sodium, ceftazidime pentahydrate - pneumonia, bacterial; soft tissue infections; pneumonia; urinary tract infections; gram-negative bacterial infections - antibatteriċi għal użu sistemiku, - zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:complicated intra-abdominal infection (ciai)complicated urinary tract infection (cuti), including pyelonephritishospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap)treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. zavicefta is also indicated for the treatment of infections due to aerobic gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

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

talzenna

pfizer europe ma eeig - talazoparib - neoplażmi tas-sider - aġenti antineoplastiċi - talzenna huwa indikat bħala monoterapija għall-kura ta ' pazjenti adulti bil-linja ġerminali brca1/2 mutazzjonijiet, li għandhom her2-negattivi avvanzat lokalment jew metastatiku tas-sider kanċer. patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. pazjenti bl-ormon tat-riċettur (hr)-kanċer tas-sider posittiv għandhom kienu ttrattati minn qabel endokrinali bbażata fuq it-terapija, jew jiġu kkunsidrati bħala mhux tajbin għall-endokrinali-terapija bbażata fuq.

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

lorviqua

pfizer europe ma eeig - lorlatinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - antineoplastic agents, protein kinase inhibitors - lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. lorviqua as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc whose disease has progressed after:alectinib or ceritinib as the first alk tyrosine kinase inhibitor (tki) therapy; orcrizotinib and at least one other alk tki.