Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ology bioservices ireland ltd - virus ta 'l-influwenza (virjon sħiħ, mhux attivat), li fih antiġen ta': a / vietnam / 1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaċċini ta 'l-influwenza - immunizzazzjoni attiva kontra s-sottotip h5n1 tal-virus ta 'l-influwenza a.. din l-indikazzjoni hija bbażata fuq dejta ta 'immunoġeniċità minn individwi mill-età ta' 6-il xahar wara amministrazzjoni ta 'żewġ dożi ta' vaċċin ippreparati bl-sottotip h5n1 razez. vepacel għandu jintuża skont il-gwida uffiċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

valneva sweden ab - 'tossina b tal-kolera, vibrio cholerae 01 - cholera; immunization - vaċċini - dukoral huwa indikat għall-immunizzazzjoni attiva kontra l-marda kkawżata minn vogrio cholerae serogroup o1 f'adulti u tfal minn sentejn li se jżuru żoni endemiċi / epidemiċi. l-użu ta 'dukoral għandha tiġi stabbilita fuq il-bażi ta' rakkomandazzjonijiet uffiċjali filwaqt li jitqiesu l-varjabilità tal-epidemjoloġija tal-post u r-riskju tat-teħid tal-marda f'żoni ġeografikament differenti u l-kundizzjonijiet waqt il-vjaġġ. dukoral m'għandux jissostitwixxi miżuri ta ' ħarsien standard. fil-każ ta ' dijarea-miżuri ta'rijidrattazzjoni għandhom jiġu istitwiti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - toxoid tad-difterite, toxoid tat-tetnu, ta ' bordetella pertussis, l-epatite b ippurifikat (rdna), haemophilus influenzae tat-tip b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; diphtheria - vaċċini - quintanrix huwa indikat għall-immunisation primarji tat-trabi (matul l-ewwel sena tal-ħajja) kontra diphtheria, tetanus, pertussis, epatite b u invażivi marda kkawżata mill-influwenza Ħemofillika tip b u għall-booster immunisation ta ' tfal matul il- it-tieni sena tal-ħajja. l-użu ta 'quintanrix għandu jiġi determinat fuq il-bażi ta' rakkomandazzjonijiet uffiċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

valneva austria gmbh - virus tal-enċefalite Ġappuniż, inattivat (strain attenwat sa14-14-2 imkabbar f'ċelloli vero) - encephalitis, japanese; immunization - vaċċini - ixiaro huwa indikat għal immunizzazzjoni attiva kontra l-enċefalite Ġappuniża f'adulti, adolexxenti, tfal u trabi b'età ta 'xahrejn u aktar. ixiaro għandu jkun ikkunsidrat għall-użu f'individwi f'riskju ta'l-espożizzjoni permezz tal-ivvjaġġar jew fil-kors ta'l-impjieg tagħhom.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

shire pharmaceutical contracts limited - epoetin delta - kidney failure, chronic; anemia - preparazzjonijiet antianemiċi - dynepo huwa indikat għall-kura ta 'anemija sintomatika assoċjata ma' insuffiċjenza renali kronika (crf) f'pazjenti adulti. jista 'jintuża f'pazjenti fuq id-dijaliżi u f'pazjenti mhux fuq id-dijalisi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

aventis pharma s.a. - telithromycin - sinusitis; tonsillitis; bronchitis, chronic; pharyngitis; community-acquired infections; pneumonia, bacterial - antibatteriċi għal użu sistemiku, - meta tippreskrivi ketek, għandha tingħata konsiderazzjoni lill-gwida uffiċjali dwar l-użu xieraq ta 'aġenti antibatteriċi u l-prevalenza lokali ta' reżistenza. ketek huwa indikat għall-kura ta 'l-infezzjonijiet li ġejjin:f'pazjenti ta' 18-il sena u oldercommunity-pnewmonja akkwiżita, ħfief jew moderati. meta jiġu ttrattati infezzjonijiet ikkawżati minn magħrufa jew suspettati beta-lactam u / jew makrolidi-razez reżistenti (skond il-passat mediku tal-pazjenti jew nazzjonali u / jew reġjonali tar-reżistenza tad-data) koperti mill-batterja tal-ispettru tal-telithromycin:taħrix akut tal-bronkite kronika;sinusite akuta;f'pazjenti ta '12-il sena u oldertonsillitis / farinġite ikkawżata minn streptococcus pyogenes bħala alternattiva meta l-antibijotiċi beta-lactam ma jkunux adatti f'pajjiżi / reġuni bi prevalenza sinifikanti ta' reżistenti għall-s. pyogenes, meta medjati b'ermtr jew bejn it.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - oritavancin (diphosphate) - soft tissue infections; skin diseases, bacterial - antibatteriċi għal użu sistemiku, - tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and paediatric patients aged 3 months and older (see sections 4. 2, 4. 4 u 5. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - aġenti antineoplastiċi - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - clostridium tetani toxoid / kvp 2242 virus / vcp1529 virus / għal vcp1533 għal virus / vcp3011 virus - immunologicals for equidae, live viral and inactivated bacterial vaccines, equine influenza virus + clostridium - Żwiemel - immunizzazzjoni attiva ta 'żwiemel ta' erba 'xhur jew akbar kontra l-influwenza taż-żwiemel biex jitnaqqsu s-sinjali kliniċi u l-eskrezzjoni tal-virus wara infezzjoni, u kontra t-tetnu biex tiġi evitata l-mortalità.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astellas pharma europe b.v. - enzalutamide - neoplasmi prostatiċi - terapija endokrinali - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.