Europska Unija - malteški - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunosoppressanti - 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.

Europska Unija - malteški - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - qasma-virus tal-influwenza, inattivat, li fih antiġen*:/california/7/2009 (h1n1)v like strain (x-179a)*propagati fil-bajd. - 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.

Europska Unija - malteški - EMA (European Medicines Agency)

sanofi pasteur s.a. - qasma-virus tal-influwenza, inattivat, li fih antiġen*:/california/7/2009 (h1n1)v like strain (x-179a)*propagati fil-bajd. - influenza, human; immunization; disease outbreaks - vaċċini - profilassi tal-influwenza f'sitwazzjoni pandemika ddikjarata uffiċjalment. vaċċin għal influwenza pandemika għandu jintuża skont il-gwida uffiċjali.

Europska Unija - malteški - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - attenuated feline rhinotracheitis herpesvirus (fhv f2 strain), inactivated feline calicivirosis antigens (fcv 431 and g1 strains), attenuated chlamydophila felis (905 strain), attenuated feline panleucopenia virus (pli iv) - immunoloġiċi għall-felini, - qtates - active immunisation of cats aged eight weeks and older:• against feline viral rhinotracheitis to reduce clinical signs;• against calicivirus infection to reduce clinical signs;• against chlamydophila felis infection to reduce clinical signs;• against feline panleucopenia to prevent mortality and clinical signs. Ġew murija onsets ta 'immunità ġimgħa wara l-kors ta' tilqim primarju għal rinotrakeite, kaliċivirus, chlamydophila felis u komponenti panleucopenia. the duration of immunity is one year after the last re-vaccination for the chlamydiosis component, and oneyear after primary vaccination and three years after the last re-vaccination for the rhinotracheitis, calicivirosis and panleucopenia components.

Europska Unija - malteški - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - virus tal-influwenza maqsuma, inattivat, li fih antiġen: razza użata bħala a / vietnam / 1194/2004 (h5n1) użata (nibrg-14) - influenza, human; immunization; disease outbreaks - vaċċini - immunizzazzjoni attiva kontra s-sottotip h5n1 tal-virus 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 ta' vaċċin ippreparati minn a/vietnam/1194/2004 nibrg-14 (h5n1) (ara sezzjoni 5. vaċċin għal influwenza prepandemika (h5n1) (virjon maqsum, mhux attivat, supplimentat) glaxosmithkline biologicals 3. 75 µg għandu jintuża skond gwida uffiċjali.

Europska Unija - malteški - EMA (European Medicines Agency)

seqirus netherlands b.v. - a/darwin/6/2021(h3n2)-like strain (a/darwin/11/2021, wild type) / a/wisconsin/67/2022 (h1n1)pdm09-like strain (a/georgia/12/2022 cvr-167) / b/austria/1359417/2021-like strain (b/singapore/wuh4618/2021) / b/phuket/3073/2013-like virus (b/singapore/inftt-16-0610/2016, wild type) - influwenza, bniedem - l-influwenza, mhux attivat, maqsuma virus jew antiġen tal-wiċċ - prophylaxis of influenza in adults and children from 2 years of age. flucelvax tetra għandu jintuża skond ir-rakkomandazzjonijiet uffiċjali.

Europska Unija - malteški - EMA (European Medicines Agency)

curium pet france - piflufolastat (18f) - neoplasmi prostatiċi - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. pylclari is indicated for the detection of prostate-specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high-risk pca prior to initial curative therapy,to localize recurrence of pca in patients with a suspected recurrence based on increasing serum prostate-specific antigen (psa) levels after primary treatment with curative intent. pylclari is indicated for use with positron emission tomography (pet).

Europska Unija - malteški - EMA (European Medicines Agency)

nanotherapeutics bohumil, s.r.o. - whole virion influenza vaccine, inactivated containing antigen of strain a/california/07/2009 (h1n1)v - disease outbreaks; influenza, human; immunization - vaċċini - profilassi tal-influwenza kkawżata mill-virus a (h1n1) v 2009. celvapan ma għandu jintuża skont il-gwida uffiċjali.

Europska Unija - malteški - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - bluetongue-virus serotype-1 antigen, bluetongue virus serotype 8 antigen - immunoloġiċi - sheep; cattle - sheepactive tilqim ta 'nagħaġ u bovini għall-prevenzjoni kontra viremja u biex tnaqqas sinjali kliniċi kkawżati mill-virus tal-bluetongue serotipi 1, 2, 4 u/ jew 8 (kombinazzjoni ta massimu 2 serotipi), l-immunizzazzjoni attiva ta' nagħaġ u bovini għall-prevenzjoni kontra viremja u biex tnaqqas sinjali kliniċi kkawżati mill-virus tal-bluetongue serotipi 1,2, 4 u/ jew 8 (kombinazzjoni ta massimu 2 serotipi), l-immunizzazzjoni attiva ta ' nagħaġ għall-prevenzjoni kontra viremja u biex tnaqqas sinjali kliniċi kkawżati mill-virus tal-bluetongue serotipi 1, 2, 4 u/jew 8 (kombinazzjoni ta massimu 2 serotipi). cattleactive tilqim ta ' baqar biex jipprevjenu viremija kkawżata mill-virus tal-bluetongue tas-serotip 1, 2, 4 u/ jew 8, u biex tnaqqas sinjali kliniċi kkawżati mill-virus tal-bluetongue serotipi meta osservati f'din l-ispeċi: serotip 1, 4 u / jew 8 (kombinazzjoni ta massimu 2 serotipi). immunizzazzjoni attiva tal-bovini għall-prevenzjoni kontra viremja ikkawżat mill-virus tal-bluetongue tas-serotip 1, 2, 4 u/ jew 8, u biex tnaqqas sinjali kliniċi kkawżati mill-virus tal-bluetongue serotipi meta osservati f'din l-ispeċi: serotip 1, 4 u / jew 8 (kombinazzjoni ta massimu 2 serotipi). immunizzazzjoni attiva ta ' nagħaġ u bovini għall-prevenzjoni kontra viremja u biex tnaqqas sinjali kliniċi kkawżati mill-virus tal-bluetongue serotipi 1, 2, 4 u/jew 8 (kombinazzjoni ta massimu 2 serotipi).

Europska Unija - malteški - EMA (European Medicines Agency)

mérial - - bluetongue l-virus tas-serotip-2 antiġen, mill-bluetongue l-virus tas-serotip-4 antiġen - virus tal-bluetongue, vaċċini virali inattivati, immunoloġiċi għall-ovidae - nagħaġ - immunizzazzjoni attiva tan-nagħaġ biex tiġi evitata l-viremija u biex jitnaqqsu s-sinjali kliniċi kkawżati mis-serotipi tal-virus bluetongue 2 u 4.