Եվրոպական Միություն - մալթերեն - EMA (European Medicines Agency)

baxter holding b.v. - pemetrexed disodium heptahydrate - carcinoma, non-small-cell lung; mesothelioma - aġenti antineoplastiċi - malignant pleural mesotheliomapemetrexed baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed baxter in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5. pemetrexed baxter is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5. pemetrexed baxter is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.

Եվրոպական Միություն - մալթերեն - EMA (European Medicines Agency)

belpharma s.a. - tasonermin - sarcoma - immunostimulanti, - beromun hu indikat fl-adulti, bħala żieda mal-intervent kirurġiku għat-tneħħija sussegwenti tat-tumur sabiex tiġi evitata jew dewmien amputazzjoni, jew fil-sitwazzjoni paljattiva, għal irresectable sarkoma tat-tessuti rotob tal-dirgħajn u r-riġlejn, użat flimkien ma ' melphalan permezz ħafif hyperthermic iżolati-il-parti tal-perfużjoni (ilp).

Եվրոպական Միություն - մալթերեն - EMA (European Medicines Agency)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva huwa indikat għall-kura ofadult u f'pazjenti pedjatriċi li jkunu għadhom kif ġew dijanjostikati-kromosoma ta ' filadelfja (bcr‑abl) positive (ph+) lewkimja kronika tal-majelojd (cml) li għalihom trapjant tal-mudullun ma jkunx meqjus bħala l-ewwel linja tal-kura. pazjenti adulti u pedjatriċi b'ph+ cml fil-fażi kronika wara l-falliment ta ' l-interferon‑alpha-terapija, jew fil-fażi aċċelerata jew blast crisis. pazjenti adulti u pedjatriċi li jkunu għadhom kif ġew dijanjostikati philadelphia chromosome positive li għandhom lewkimja limfoblastika akuta (ph+ all) integrata b'kimoterapija. pazjenti adulti b'all rikadut jew refrattarju ph+ all bħala monoterapija. pazjenti adulti b'mard majelodisplastiku/majeloproliferattiv (mds/mpd) assoċjat ma ' plejtlits-riċettur tal-fattur tat-tkabbir derivat (pdgfr) ġeni mill-ġdid l-arranġamenti. pazjenti adulti b'avvanzati sindrome ipereżinofiliku (hes) u/jew lewkimja kronika eosinofilika (cel) b'fip1l1-pdgfra arranġament mill-ġdid. l-effett ta ' imatinib fuq l-eżitu tal-trapjant tal-mudullun għadu ma ġiex determinat. imatinib teva is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pazjenti li għandhom livell baxx jew l-riskju baxx ħafna ta ' rikorrenza m'għandhomx jirċievu kura awżiljarja. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. Ħlief fil għadhom kif ġew dijanjostikati cml ta ' fażi kronika, m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

Եվրոպական Միություն - մալթերեն - EMA (European Medicines Agency)

swedish orphan biovitrum ab - collagenase clostridium histolyticum - kuntratt dupuytren - mediċini oħra għal disturbi fis-sistema muskoloskeletali - , the treatment of dupuytren’s contracture in adult patients with a palpable cord. , it-trattament ta'rġiel adulti bil-marda ta'peyronie bil-kundizzjoni tal-plakka u l-liwi deformità tal mill-inqas 30 grad fil-bidu tat-terapija.

Եվրոպական Միություն - մալթերեն - EMA (European Medicines Agency)

pfizer limited - pneumococcal oligosaccharide serotype 18c, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14 - pneumococcal infections; immunization - vaċċini - attiva tilqim kontra mard ikkawżat minn streptococcus pneumoniae serotipi 4, 6b, 9v, 14, 18 c, 19f u 23f (inklużi sepsis, meninġite, pnewmonja, bacteraemia u otiti medja akuta) fit-trabi u tfal minn xahrejn sa ħames snin ta ' età. l-użu ta 'prevenar għandu jkun stabbilit fuq il-bażi ta' rakkomandazzjonijiet uffiċjali filwaqt li jitqiesu l-impatt ta 'mard invażiv fi gruppi differenti ta' età, kif ukoll il-varjabilità tal-epidemjoloġija tas-serotip f'żoni ġeografiċi differenti.

Եվրոպական Միություն - մալթերեն - EMA (European Medicines Agency)

sanofi pasteur - chimeric yellow fever dengue virus serotype 1 (live, attenuated), chimeric yellow fever dengue virus serotype 2 (live, attenuated), chimeric yellow fever dengue virus serotype 3 (live, attenuated), chimeric yellow fever dengue virus serotype 4 (live, attenuated) - Ħnieżer - vaċċini - dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 to 45 years of age with test-confirmed previous dengue infection (see sections 4. 2, 4. 4 u 4. l-użu ta dengvaxia għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Եվրոպական Միություն - մալթերեն - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - eftrenonacog alfa - hemofilja b - il-vitamina k u oħra hemostatics, fatturi ta ' koagulazzjoni tad-demm - trattament u profilassi ta 'fsada f'pazjenti b'emofilja b (defiċjenza konġenitali tal-fattur ix).

Եվրոպական Միություն - մալթերեն - EMA (European Medicines Agency)

pharmaxis europe limited - mannitol - fibrożi ċistika - sogħla u preparazzjonijiet kesħin - bronchitol huwa indikat għat-trattament tal-fibrożi ċistika (fk) f'adulti ta '18-il sena' l fuq bħala terapija add-on għall-aħjar standard ta 'kura.

Եվրոպական Միություն - մալթերեն - EMA (European Medicines Agency)

novo nordisk a/s - eptacog alfa (attivat) - hemophilia b; thrombasthenia; factor vii deficiency; hemophilia a - sustanzi kontra l-emorraġija - novoseven huwa indikat għall-kura ta 'episodji ta' emorraġija u għall-prevenzjoni ta ' fsada f'dawk li jkunu għaddejjin minn intervent kirurġiku jew proċeduri invażivi fil-pazjenti li ġejjin gruppi:f'pazjenti b'emofilja konġenitali b'inibituri għall-fatturi tal-koagulazzjoni viii jew ix > 5 unitajiet bethesda (bu);fil-pazjenti bl-emofilja konġenitali li huma mistennija li jkollhom rispons anamnestiku għoli għall-fattur viii jew tal-fattur ix-amministrazzjoni;f'pazjenti bl-emofilja akkwiżita;f'pazjenti b'nuqqas konġenitali tal-fattur vii-defiċjenza;f'pazjenti bi trombastenija tal-thrombasthenia b'antikorpi għal-plejtlits glycoprotein (gp) iib-iiia u / jew tal-lewkoċiti tal-bniedem antiġeni (hla), u bil-passat jew fil-preżent ir-refrattorjetà għal trasfużjonijiet tal-plejtlits. f'pazjenti bi trombastenija tal-thrombasthenia mal-passat jew fil-preżent ir-refrattorjetà għal trasfużjonijiet tal-plejtlits, jew fejn l-plejtlits mhux disponibbli.

Եվրոպական Միություն - մալթերեն - EMA (European Medicines Agency)

octapharma ab - simoctocog alfa - hemofilja a - fatturi ta 'koagulazzjoni tad-demm - trattament u profilassi ta 'fsada f'pazjenti b'emofilja a (nuqqas konġenitali ta' fattur viii). nuwiq jistgħu jiġu użati għall-gruppi kollha tal-età.