Unjoni Ewropea - Malti - EMA (European Medicines Agency)

recordati ireland ltd - silodosin - iperplażja prostatika - uroloġiċi - trattament tas-sinjali u sintomi ta 'iperplażja beninna tal-prostata (bph).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astellas pharma gmbh - tacrolimus - dermatite, atopika - preparazzjonijiet oħra dermatoloġiċi - kura ta 'dermatite atopika moderata għal severa f'adulti li ma jirrispondux b'mod adegwat għal jew mhumiex intolleranti għal terapiji konvenzjonali bħal kortikosterojdi topiċi. kura ta 'dermatite atopika moderata għal severa fit-tfal (ta' sentejn jew aktar) li naqset milli twieġeb b'mod adegwat għal terapiji konvenzjonali bħal kortikosterojdi topiċi. l-manteniment tat-trattament ta 'dermatite atopika moderata għal severa għall-prevenzjoni tal-flares u l-estensjoni tal-flare intervalli mingħajr f'pazjenti li qed jesperjenzaw il-frekwenza għolja ta' rkadar tal-marda (i. li jseħħu 4 darbiet jew aktar fis-sena) li kellhom rispons inizjali għal massimu ta '6 ġimgħat trattament ta' ingwent ta 'tacrolimus darbtejn kuljum (leżjonijiet approvati, kważi approvati jew affettwati b'mod ħafif).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

recordati ireland ltd - silodosin - iperplażja prostatika - uroloġiċi - trattament tas-sinjali u sintomi ta 'iperplażja beninna tal-prostata (bph).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - immunosoppressanti - jekk jogħġbok irreferi għas-sezzjoni 4. 1 tas-sommarju tal-karatteristiċi tal-prodott fid-dokument ta 'informazzjoni tal-prodott.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

krka, d.d., novo mesto - clopidogrel (as hydrogen sulfate) - peripheral vascular diseases; stroke; acute coronary syndrome; myocardial infarction - aġenti antitrombotiċi - - prevenzjoni sekondarja prevenzjoni ta ' avvenimenti aterotrombotiċi clopidogrel huwa indikat fl:pazjenti adulti li jbatu minn infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard arterjali periferali. pazjenti adulti li jsofru mis-sindromu koronarju akut:- nuqqas ta elevazzjoni tas-segment st sindromu koronarju akut (anġina instabbli jew mhux-mewġa-q infart mijokardijaku), li jinkludu pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutanju, flimkien ma ' acetylsalicylic acid (asa). l - elevazzjoni tas-segment st infart mijokardijaku akut, flimkien ma ' asa f'medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika. il-prevenzjoni ta aterotrombotiċi u avvenimenti tromboemboliċi fil-fibrillazzjoni atrijali:- fil-pazjenti adulti li jbatu minn fibrillazzjoni atrijali li jkollhom mill-inqas fattur ta 'riskju wieħed għall-episodji vaskulari, mhumiex adattati għall-kura bl-antagonisti tal-vitamina k (vka) u li għandhom baxx-riskju ta'fsada, clopidogrel huwa indikat, flimkien ma' asa għall-prevenzjoni tal-aterotrombotiċi u avvenimenti tromboemboliċi, inkluż puplesija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - adalimumab - hidradenitis suppurativa; arthritis, psoriatic; psoriasis; crohn disease; arthritis, juvenile rheumatoid; uveitis; arthritis, rheumatoid; colitis, ulcerative; spondylitis, ankylosing - immunosoppressanti - jekk jogħġbok irreferi għas-sezzjoni 4. 1 tas-sommarju tal-karatteristiċi tal-prodott fid-dokument ta 'informazzjoni tal-prodott.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalidomide - majloma multipla - immunosoppressanti - multiple myelomalenalidomide accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) huwa indikat għall-kura ta ' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal trapjant tal -. lenalidomide qbil flimkien ma 'dexamethasone hu indikat għall-kura ta' majeloma multipla f'pazjenti adulti li jkunu rċevew mill-anqas terapija waħda qabel. follicular lymphomalenalidomide accord in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

recordati ireland ltd - silodosin - iperplażja prostatika - urologicals, alpha-adrenoreceptor antagonisti - trattament tas-sinjali u s-sintomi tal-iperplasija beninna tal-prostata (bph), fl-irġiel adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - emoglobinurja, paroxysmal - immunosuppressanti selettivi - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - acetylsalicylic acid, clopidogrel hydrogen sulfate - acute coronary syndrome; myocardial infarction - aġenti antitrombotiċi - clopidogrel/acetylsalicylic acid mylan huwa indikat għall-prevenzjoni sekondarja ta ' avvenimenti aterotrombotiċi f'pazjenti adulti li diġà qed jieħdu ż-żewġ clopidogrel u acetylsalicylic acid (asa). clopidogrel/acetylsalicylic acid mylan huwa kombinazzjoni b'doża fissa tal-prodott mediċinali għall-kontinwazzjoni tat-terapija:mhux elevazzjoni tas-segment st sindromu koronarju akut (anġina instabbli jew mhux-mewġa-q infart mijokardijaku) li jinkludu pazjenti fi proċess li titpoġġa stent wara koronarju perkutanju interventionst elevazzjoni tas-segment infart mijokardijaku akut fil-medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika.