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

bovela

boehringer ingelheim vetmedica gmbh - virus tal-virus tad-dijarea virali ħaj modifikat tat-tip 1, razza ġenitur mhux ċitopatiku ke-9 u virus tal-vajrus dijarea virali modifikat tat-tip 2, razza ġenitur mhux ċitopatika ny-93 - immunoloġiċi għall-bovini, vaċċini virali Ħajjin - għall-immunizzazzjoni attiva tal-baqar minn 3 xhur ta 'l-età li jnaqqsu l-żieda fit-temperatura u biex jitnaqqas it-tnaqqis tal-għadd ta' lewkoċiti kkawżati minn bovini virali dijarea virus (bvdv-1 u bvdv-2), u biex jitnaqqsu l-virus tal-tixrid u l-viremija kkawżata minn bvdv-2. għall-immunizzazzjoni attiva tal-baqar kontra l-bvdv-1 u bvdv-2, biex jipprevjenu l-twelid persistenti infettati għoġġiela kkawżati mill-infezzjoni transplaċentali.

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.

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

mvabea

janssen-cilag international n.v.    - recombinant modified vaccinia ankara bavarian nordic virus encoding the: ebola virus zaire (zebov) mayinga strain glycoprotein (gp); ebola virus sudan gulu strain gp; ebola virus taï forest strain nucleoprotein and the marburg virus musoke strain gp - emorraġiku-deni, l-ebola - vaċċini - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.

Suvaxyn PRRS MLV Unjoni Ewropea - Malti - EMA (European Medicines Agency)

suvaxyn prrs mlv

zoetis belgium sa - virus modifikat ħaj tas-sindrome riproduttiv u respiratorju tal-ħnieżer - immunologicals for suidae, live viral vaccines - majjali - għall-immunizzazzjoni attiva tal-klinikament f'saħħithom-ħnieżer mill-1 ta'kuljum ta'l-età fil-respiratorja fil-majjali u l-riproduttiva sindromu (prrs) tal-virus kontaminati-ambjent, biex inaqqas viremja u fl-imnieħer jixħtu ikkawżata minn infezzjoni bil-varjanti ewropej tal-prrs virus (ġenotip 1). - simna tal-ħnieżer: barra minn hekk, it-tilqima tal-kienu seronegattivi għal 1-ġurnata qżieqeż intweriet li tnaqqas b'mod sinifikanti leżjonijet fil-pulmun kontra l-isfida amministrati fis-26 ġimgħa wara t-tilqima. it-tilqima ta 'qżieqeż seronegattivi ta' ġimgħatejn kienet murija li tnaqqas b'mod sinifikanti l-leżjonijiet tal-pulmun u tfaqqa 'mill-ħalq kontra l-isfida mogħtija f'28 ġurnata u f'16-il ġimgħa wara l-vaċċinazzjoni. il-qżieqeż u majjaliet: barra minn hekk, qabel it-tqala tilqim ta klinikament f'saħħithom-ħnieżer nisa żgħar u majjaliet, jew seropożittivi jew kienu seronegattivi għal, intweriet li tnaqqas l-infezzjoni transplaċentali kkawżata mill-prrs virus waqt it-tielet trimestru tat-tqala, u biex jitnaqqsu l-assoċjat impatt negattiv fuq il-prestazzjoni riproduttiva (tnaqqis ta 'l-okkorrenza ta' trabi li jitwieldu mejta, tal-qażquż viremija fit-twelid u fil-ftim, tal-pulmun u leżjonijiet tal-tagħbija virali fil-pulmuni fil-qżieqeż fil-ftim).

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

breyanzi

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - aġenti antineoplastiċi - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Fingolimod Mylan Unjoni Ewropea - Malti - EMA (European Medicines Agency)

fingolimod mylan

mylan ireland limited - fingolimod hydrochloride - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 u 5. 1)orpatients mal li qed tevolvi malajr severa sklerożi multipla li tirkadi u tbatti l-isklerożi multipla definita minn 2 jew iktar diżabilità attakki reċidivi fis-sena, u b'1 jew aktar gadolinium-tisħiħ tal-leżjonijiet fuq il-moħħ ta 'l-mri jew żieda sinifikanti fil-t2 tal-leżjonijiet tat-tagħbija kif meta mqabbel ma ' qabel riċenti ta ' l-mri.

Fingolimod Mylan Unjoni Ewropea - Malti - EMA (European Medicines Agency)

fingolimod mylan

mylan ireland limited - fingolimod hydrochloride - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 u 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

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

ngenla

pfizer europe ma eeig - somatrogon - growth and development - pitwitarja u l-assi ipotalamika-ormoni u analogi - indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone.

Atazanavir Mylan Unjoni Ewropea - Malti - EMA (European Medicines Agency)

atazanavir mylan

mylan pharmaceuticals limited - atazanavir (as sulfate) - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - atazanavir mylan, mogħti flimkien ma 'doża baxxa ta' ritonavir, huwa indikat għall-kura ta 'adulti infettati bl-hiv 1 u pazjenti pedjatriċi ta' 6 snin jew aktar flimkien ma 'prodotti mediċinali antiretrovirali oħra. ibbażat fuq disponibbli viroloġiku u kliniku minn pazjenti adulti, m'hu mistenni ebda benefiċċju f'pazjenti b'razez reżistenti għall-inibituri ta'proteasi multipliċi (≥ 4 mutazzjonijet pi). hemm tagħrif limitat ħafna disponibbli minn tfal ta '6 snin għal inqas minn 18-il sena. l-għażla ta ' atazanavir mylan fl-esperjenza ta'trattament għall-adulti u f'pazjenti pedjatriċi għandu jkun ibbażat fuq testijiet tar-reżistenza virali u l-istorja tat-trattament tal-pazjent.

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

thorinane

pharmathen s.a. - enoxaparin sodium - tromboemboliżmu tal-vini - aġenti antitrombotiċi - thorinane huwa indikat għall-adulti għall -: - profilassi ta ' tromboemboliżmu fil-vini, partikolarment f'pazjenti li jgħaddu minn kirurġija ortopedika, ġenerali jew onkoloġika-kirurġija. - profilassi ta 'tromboemboliżmu venuż f'pazjenti bedridden minħabba mard akut inkluż akuta insuffiċjenza tal-qalb, waqfien akut tan-nifs, infezzjonijiet gravi, kif ukoll l-aggravament tal-mard rewmatiku li jikkawżaw l-immobbilizzazzjoni tal-pazjent (japplika għall-qawwiet ta' 40 mg/0. 4 ml). - it-trattament ta 'trombożi f' vina fonda (dvt), kkumplikati jew mhux ikkomplikati minn emboliżmu pulmonari. trattament ta 'anġina mhux stabbli u n-non-q-wave' infart mijokardijaku, flimkien ma ' acetylsalicylic acid (asa). - it-trattament ta 'elevazzjoni tas-segment st' infart mijokardijaku (stemi) inklużi pazjenti li ser jiġu ttrattati b'mod konservattiv jew li wara jgħaddu minn koronarju perkutanju l-anġoplastika (japplika għall-qawwiet ta ' 60 mg/0. 6 ml, 80 mg/0. 8 ml, u 100 mg/1 ml). - tagħqid tad-demm għall-prevenzjoni fil-ċ-ċirkolazzjoni ekstrakorporali matul l-emodijalisi. il-prevenzjoni u l-kura ta ' diversi mard relatati mal-emboli tad-demm fl-adulti.