Purevax RCCh Unjoni Ewropea - Malti - EMA (European Medicines Agency)

purevax rcch

merial - attenuated feline rhinotracheitis herpesvirus (fhv f2 strain), inactivated feline calicivirosis antigens (fcv 431 and g1 strains), attenuated chlamydophila felis (905 strain) - immunoloġiċi għall-felini, - qtates - active immunisation of cats aged 8 weeks and older:against feline viral rhinotracheitis to reduce clinical signs;against calicivirus infection to reduce clinical signs and excretion;against chlamydophila felis infection to reduce clinical signs. Ġew murija onsets ta 'immunità 1 ġimgħa wara l-kors ta' tilqim primarju għal rinotrakeite, kaliċivirus u komponenti ta 'chlamydophila felis. it-tul ta 'l-immunità huwa ta' sena wara l-aħħar vaċċinazzjoni (mill-ġdid).

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

procomvax

sanofi pasteur msd, snc - polyribosylribitol phosphate mill-haemophilus influenzae tat-tip b bħala prp-ompc, il-membrana ta 'barra kumpless tal-proteina tal neisseria meningitidis (il-membrana ta' barra kumpless tal-proteina tar-razza b11 ta 'neisseria meningitidis sottogrupp b), adsorbit ta' l-epatite b-antiġen tal-wiċċ prodott f'ċelloli tal-ħmira rikombinanti (saccharomyces cerevisiae) - hepatitis b; meningitis, haemophilus; immunization - vaċċini - procomvax huwa indikat għall-vaċċinazzjoni kontra l-marda invażivi ikkawżat minn influwenza Ħemofillika tip b u kontra l-infezzjoni kkawżat mill-sottotipi magħrufa kollha tal-virus tal-hepatitis b fit-trabi 6 ġimgħat sa 15-il xahar.

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

hbvaxpro

merck sharp & dohme b.v.  - epatite b, antiġen tal-wiċċ rikombinanti - hepatitis b; immunization - vaċċini - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. l-speċifiċi fil-kategoriji tar-riskju biex jiġu immunizzati għandhom jiġu determinati fuq il-bażi tar-rakkomandazzjonijiet uffiċjali. huwa mistenni li epatite d tiġi evitata wkoll permezz tat-tilqima b'hbvaxpro billi l-epatite d (ikkawżata mill-aġent delta) ma tfeġġx fl-assenza ta ' l-epatite b infezzjoni. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. l-speċifiċi fil-kategoriji tar-riskju biex jiġu immunizzati għandhom jiġu determinati fuq il-bażi tar-rakkomandazzjonijiet uffiċjali. huwa mistenni li epatite d tiġi evitata wkoll permezz tat-tilqima b'hbvaxpro billi l-epatite d (ikkawżata mill-aġent delta) ma tfeġġx fl-assenza ta ' l-epatite b infezzjoni. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. huwa mistenni li epatite d tiġi evitata wkoll permezz tat-tilqima b'hbvaxpro billi l-epatite d (ikkawżata mill-aġent delta) ma sseħħx fin-nuqqas ta ' infezzjoni tal-epatite b.

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

foclivia

seqirus s.r.l.  - antiġeni tal-wiċċ tal-virus ta 'l-influwenza, inattivati: a / vjet nam / 1194/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaċċini ta 'l-influwenza - profilassi tal-influwenza f'sitwazzjoni pandemika ddikjarata uffiċjalment. il-vaċċin kontra l-influwenza pandemika għandu jintuża skond il-gwida uffiċjali.

Twinrix Adult Unjoni Ewropea - Malti - EMA (European Medicines Agency)

twinrix adult

glaxosmithkline biologicals s.a. - virus tal-epatite a (inattivat), l-epatite b-antiġen tal-wiċċ - hepatitis b; hepatitis a; immunization - vaċċini - twinrix adult huwa indikat għall-użu f'adulti mhux adulti u adolexxenti ta '16-il sena' il fuq u li huma f'riskju kemm ta 'infezzjoni ta' l-epatite a kif ukoll ta 'l-epatite b.

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

ervebo

merck sharp & dohme b.v.  - rikombinanti, l-istomatite stomatite virus (razza indiana) bi tħassir tal-pakkett glycoprotein, sostitwit bl-zaire ebolavirus (razza kikwit 1995) tal-wiċċ glycoprotein - emorraġiku-deni, l-ebola - vaċċini - ervebo is indicated for active immunization of individuals 1 year of age or older to protect against ebola virus disease (evd) caused by zaire ebola virus. l-użu ta ervebo għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics Unjoni Ewropea - Malti - EMA (European Medicines Agency)

prepandemic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted) novartis vaccines and diagnostics

novartis vaccines and diagnostics s.r.l. - antigens tal-wiċċ tal-virus tal-influwenza (emagglutinin u neuraminidase) ta 'razza a / vjet nam / 1194/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaċċini - immunizzazzjoni attiva kontra s-sottotip h5n1 tal-virus influwenza a.. , , this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain. , , prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.

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

fendrix

glaxosmithkline biologicals s.a. - antigen tal-wiċċ ta 'l-epatite b - hepatitis b; immunization - vaċċini - fendrix huwa indikat fl-adoloxxenti u adulti mill-età ta ' 15-il sena ' l quddiem għall-immunisation attiva kontra l-infezzjoni tal-mikrobu epatite b (hbv) ikkaġunata sottotipi magħrufa kollha għall-pazjenti b ' insuffiċjenza renali (inkluż pre-haemodialysis u haemodialysis pazjenti).

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

aflunov

seqirus s.r.l.  - antiġeni tal-wiċċ tal-virus tal-influwenza (emagglutinin u neuraminidase) ta 'razza: razza a / dundjan / turkija / 1/05 (h5n1) (nibrg-23) - influenza, human; immunization; disease outbreaks - vaċċini - immunizzazzjoni attiva kontra s-sottotip h5n1 tal-virus ta 'l-influwenza a. din l-indikazzjoni hija bbażata fuq dejta ta 'immunoġeniċità minn individwi b'saħħithom mill-età ta' 18-il sena'l quddiem wara l-amministrazzjoni ta ' żewġ dożi tal-vaċċin li fih a/turkey/turkey/1/05 (h5n1) like strain. aflunov għandu jintuża skond ir-rakkomandazzjonijiet uffiċjali.

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

opdivo

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.