Европска Унија - Мелтешки - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrastim - newtropenja - immunostimulanti, - tnaqqis fit-tul tal-neutropenia u l-inċidenza tal-marda bid-deni neutropenia fil-pazjenti adulti ttrattati ċitotossiċi chemotherapy għall-malignancy (bl-eċċezzjoni ta ' kronika myeloid lewċemja u myelodysplastic sindromi).

Европска Унија - Мелтешки - EMA (European Medicines Agency)

novartis europharm ltd - ofatumumab - lewkimja, linfokitika, kronika, b-Ċellula - antikorpi monoklonali - ma kienux trattati qabel lewkimja limfoċitika kronika (cll): arzerra flimkien ma 'chlorambucil jew bendamustine huwa indikat għall-kura ta' pazjenti b'cll li ma rċevew terapija minn qabel u li mhumiex eliġibbli għall-fludarabine-terapija bbażata fuq. rkadew cll: arzerra huwa indikat flimkien ma 'fludarabine u cyclophosphamide għat-trattament ta' pazjenti adulti b'all rikadut cll. refrattarji cll: arzerra huwa indikat għall-kura ta cll f'pazjenti li huma refrattarji għal pazjenti b'b-ll u alemtuzumab.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

ipsen pharma - somatropin - turner syndrome; dwarfism, pituitary - ormoni u analogi pitwitarji u ipotalamiċi - trattament fuq medda twila ta 'tfal bi ħsara fit-tkabbir minħabba sekrezzjoni inadegwata ta' l-ormon tat-tkabbir endoġenu. -kura fit-tul ta 'falliment tat-tkabbir assoċjat mas-sindromu ta' turner. it-trattament ta 'qabel il-puberta tfal b'falliment tat-tkabbir assoċjat ma' insuffiċjenza kronika tal-kliewi sa l-żmien tat-trapjant renali. is-sostituzzjoni tal-ormon tat-tkabbir endoġenu f'adulti b'defiċjenza tal-ormon tat-tkabbir ta ' jew fit-tfulija jew adulti bidu etjoloġija. ormon tat-tkabbir għandu jiġi kkonfermat kif suppost qabel it-trattament.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

teva pharma b.v. - pioglitazone hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - pioglitazone is indicated in the treatment of type-2 diabetes mellitus as monotherapy: , in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. , pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. wara l-bidu tat-terapija b'pioglitazone, il-pazjenti għandhom jiġu riveduti wara 3 sa 6 xhur biex tevalwa l-adegwatezza tal-rispons għall-kura (e. it-tnaqqis fl-hba1c). f'pazjenti li jonqsu li juru rispons adegwat, pioglitazone għandu jitwaqqaf. fid-dawl tar-riskji potenzjali fit-tul mal-terapija, it-tobba għandhom jikkonfermaw fil-sussegwenti ta 'rutina reviżjonijiet li l-benefiċċju ta' pioglitazone jinżamm.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

teva b.v. - pioglitazone hydrochloride - diabetes mellitus, tip 2 - l-apparat alimentari u tal-metaboliżmu - pioglitazone huwa ndikat fil-kura ta 'dijabete mellitus tip 2:bħala monotherapija - fil-pazjenti adulti (speċjalment pażjenti b'piż żejjed) li mhumiex ikkontrollati biżżejjed bid-dieta u l-eżerċizzju li għalihom metformin mhux adattat minħabba kontra-indikazzjonijiet jew intoleranceas terapija dupliċi orali flimkien mal - metformina, fil-pazjenti adulti (speċjalment pażjenti b'piż żejjed) b'kontroll gliċemiku insuffiċjenti minkejja l-ogħla doża ttollerata ta' monoterapija b'metformin - sulphonylurea, biss f'pazjenti adulti li juru intolleranza għal metformina jew li għalihom il-metformin huwa kontra-indikat, b'kontroll gliċemiku insuffiċjenti minkejja l-ogħla doża ttollerata ta 'monoterapija b'sulphonylureaas terapija orali trippla flimkien ma' - metformin u mediċina tat-tip sulphonylurea, f'pazjenti adulti (speċjalment pażjenti b'piż żejjed) b'kontroll gliċemiku insuffiċjenti minkejja terapija doppja mill-ħalq. pioglitazone huwa indikat ukoll għall-użu flimkien ma ' insulina fil-dijabete tat-tip 2 mellitus f'pazjenti adulti b'kontroll gliċemiku insuffiċjenti bl-insulina u li għalihom metformin mhux adattat minħabba kontra-indikazzjonijiet jew intolleranza. wara l-bidu tat-terapija b'pioglitazone, il-pazjenti għandhom jiġu riveduti wara 3 sa 6 xhur biex tevalwa l-adegwatezza tal-rispons għall-kura (e. it-tnaqqis fl-hba1c). f'pazjenti li jonqsu li juru rispons adegwat, pioglitazone għandu jitwaqqaf. fid-dawl tar-riskji potenzjali fit-tul mal-terapija, it-tobba għandhom jikkonfermaw fil-sussegwenti ta 'rutina reviżjonijiet li l-benefiċċju ta' pioglitazone jinżamm.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - adalimumab - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - immunosoppressanti - jekk jogħġbok irreferi għad-dokument ta 'informazzjoni dwar il-prodott.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

orion corporation - tasipimidine sulfate - other hypnotics and sedatives - klieb - alleviation of situational anxiety and fear in dogs triggered by e. travel, noise, owner departure, veterinary visits.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

astrazeneca ab - tezepelumab - ażma - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - tezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - karċinoma, pulmun mhux taċ-Ċellula Żgħira - antineoplastika u immunomodulanti l-aġenti, antikorpi monoklonali - nivolumab bms huwa indikat għall-kura ta 'kanċer tal-pulmun taċ-ċelluli mhux żgħar tat-tip squamous lokalment avvanzat jew metastatiku (nsclc) wara kimoterapija minn qabel fl-adulti.

Европска Унија - Мелтешки - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.