Euroopa Liit - malta - EMA (European Medicines Agency)

novartis europharm limited  - gozetotide - radjonuklidi imaging - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. locametz, after radiolabelling with gallium 68, 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 primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.

Euroopa Liit - malta - EMA (European Medicines Agency)

amicus therapeutics europe limited - cipaglucosidase alfa - mard tal-Ħażna tal-glukoġen tat-tip ii - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset pompe disease (acid α-glucosidase [gaa] deficiency).

Euroopa Liit - malta - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - pegunigalsidase alfa - marda ta 'fabry - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of fabry disease (deficiency of alpha-galactosidase).

Euroopa Liit - malta - EMA (European Medicines Agency)

viatris limited - aflibercept - macular edema; retinal vein occlusion; diabetic retinopathy; myopia, degenerative; diabetes complications - oftalmoloġiċi - yesafili is indicated for adults for the treatment ofneovascular (wet) age-related macular degeneration (amd) (see section 5. 1),visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo) (see section 5. 1),visual impairment due to diabetic macular oedema (dme) (see section 5. 1),visual impairment due to myopic choroidal neovascularisation (myopic cnv) (see section 5.

Euroopa Liit - malta - EMA (European Medicines Agency)

biogen netherlands b.v.  - interferon beta-1a - sklerosi multipla - immunostimulanti, - avonex hu indikat għall-kura ta': pazjenti djanjostikati bl-isklerożi multipla reċidiva-isklerożi multipla (ms). fi provi kliniċi, dan ġie karaterizzat jew aktar akuta tal-aggravar tal-attakki (rikaduti) fit-tliet snin preċedenti mingħajr evidenza ta kontinwu progressjoni bejn l-attakki reċidivi; avonex inaqqas il-progressjoni tad-diżabilità u jnaqqas il-frekwenza tal-attakki reċidivi;pazjenti b'avveniment wieħed demyelinating bi proċess infjammatorju attiv, jekk ikun sever biżżejjed li jkun jeħtieġ il-kura b'kortikosterojdi ġol-vina, jekk dijanjosi alternattivi kienu esklużi, u jekk kien stabbilit li huma f'riskju għoli li jiżviluppaw ms klinikament definita. avonex għandu jitwaqqaf f'pazjenti li jiżviluppaw ms progressiva.

Euroopa Liit - malta - EMA (European Medicines Agency)

accord healthcare s.l.u. - eptifibatide - infart mijokardijaku - aġenti antitrombotiċi - eptifibatide accord huwa maħsub għall-użu ma 'acetylsalicylic acid u heparin mhux frazzjonat. eptifibatide qbil huwa indikat għall-prevenzjoni ta 'infart mijokardijaku bikri fl-adulti li jippreżentaw b'anġina instabbli jew mhux-mewġa-q infart mijokardijaku, bl-aħħar episodju ta' uġigħ fis-sider li jseħħu fi żmien 24 siegħa u ma ' l-elettrokardjogramma (ecg) il-bidliet u/jew enzimi kardijaċi elevati. il-pazjenti l-aktar probabbli li jibbenefikaw mill-eptifibatide qbil-trattament huma dawk f'riskju għoli li jiżviluppaw infart mijokardijaku fi żmien l-ewwel 3-4 ijiem wara l-bidu ta 'anġina' sintomi, inkluż pereżempju dawk li huma probabbli li jgħaddu minn kmieni ptca (koronarju perkutanju transluminali angioplasty).

Euroopa Liit - malta - EMA (European Medicines Agency)

zoetis belgium sa - virus rikombinanti taċ-circovirus porċin (cpcv) 1-2, inattivat - immunoloġiċi - majjali (ħnienes) - immunizzazzjoni attiva ta 'qżieqeż fuq l-età ta' tliet ġimgħat kontra l-virus porcine circovirus tip 2 (pcv2) biex titnaqqas it-tagħbija virali fid-demm u fit-tessuti limfodje, u l-leżjonijiet f'tessuti limfojde assoċjati ma 'infezzjoni b'pcv2, kif ukoll biex tnaqqas sinjali kliniċi - li jinkludu telf ta 'kuljum ta' żieda fil-piż, u l-mortalità assoċjata ma wara l-ftim tal-ġisem, ħela sindromu.

Euroopa Liit - malta - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - eptifibatide - angina, unstable; myocardial infarction - aġenti antitrombotiċi - integrilin huwa maħsub għall-użu ma 'acetylsalicylic acid u heparin mhux frazzjonat. integrilin huwa indikat għall-prevenzjoni ta 'infart mijokardijaku bikri f'pazjenti li jippreżentaw b'anġina instabbli jew mhux-mewġa-q infart mijokardijaku bl-aħħar episodju ta' uġigħ fis-sider li jseħħu fi żmien 24 siegħa u mal-bidliet fl-ecg u / jew enzimi kardijaċi elevati. il-pazjenti l-aktar probabbli li jibbenefikaw mill-integrilin-trattament huma dawk f'riskju għoli li jiżviluppaw infart mijokardijaku fi żmien l-ewwel 3-4 ijiem wara l-bidu ta 'anġina' sintomi, inkluż pereżempju dawk li huma probabbli li jgħaddu minn kmieni koronarju perkutanju transluminali l-anġoplastika (ptca).

Euroopa Liit - malta - EMA (European Medicines Agency)

biomarin international limited - galsulfase - mucopolysaccharidosis vi - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - naglazyme huwa indikat għal terapija s-sostituzzjoni ta ' l-enżima fit-tul fil-pazjenti bl-djanjosi konfermati ta ' mucopolysaccharidosis vi (mps vi; defiċjenza n-acetylgalactosamine-4-sulfatase; maroteaux-lamy syndrome) (ara taqsima 5. kif għall-lisosomali disturbi ġenetiċi, huwa ta'importanza primarja, speċjalment fil-forom severi, li tinbeda l-kura malajr kemm jista 'jkun, qabel id-dehra ta jitfaċċaw manifestazzjonijiet kliniċi mhux reversibbli ta' l-mard. punt kruċjali huwa li tikkura pazjenti żgħar li għandhom bejn.

Euroopa Liit - malta - EMA (European Medicines Agency)

sanofi b.v. - thyrotropin alfa - neoplażmi tat-tirojde - - lobu pitwitarju anterjuri-ormoni u analogi, pitwitarja u l-assi ipotalamika-ormoni u analogi - thyrogen is indicated for use with serum thyroglobulin (tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (thst). low risk patients with well-differentiated thyroid carcinoma who have undetectable serum tg levels on thst and no rh (recombinant human) tsh-stimulated increase of tg levels may be followed-up by assaying rh tsh-stimulated tg levels. thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mci (1. 1 gbq) to 100 mci (3. 7 gbq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.