Unjoni Ewropea - Malti - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

viatris healthcare limited - tolcapone - marda ta 'parkinson - kontra l-marda ta ' parkinson id-drogi, aġenti dopaminerġiċi oħra - tasmar hija indikata fil kombinazzjoni ma ' ticlopidine hydrochloride / benserazide jew ticlopidine hydrochloride / carbidopa għall-użu fil-pazjenti ma ticlopidine hydrochloride-responsivi idiopathic parkinson's marda u oxxillazzjonijiet vetturi bil-mutur, li naqas milli jirrispondi għal jew huma intolerant ta ' xulxin inibituri ta ' catechol-o-methyltransferase (comt). minħabba r-riskju ta potenzjalment fatali, ħsara fil-fwied akut, tasmar ma għandhomx jiġu kkunsidrati bħala l-ewwel linja ta 'trattament miżjud ma' levodopa / benserazide jew levodopa / carbidopa. peress li tasmar għandu jiġi użat biss flimkien ma 'levodopa / benserazide u b'levodopa / carbidopa, l-tagħrif preskritt individwalment għal dawn l-sustanzi ta' levodopa hija applikabbli għall-użu tagħhom flimkien ma ' tasmar.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

regeneron uk limited - rilonacept - perjodiċi assoċjati mal-cryopyrin sindromi - immunosoppressanti - rilonacept regeneron hija indikata għat-trattament ta ' cryopyrin assoċjati perjodiċi sindromi (brieret) b'sintomi severi, inklużi familjali syndrome auto-infjamazzjoni kiesħa (fcas) u muckle-bjar syndrome (mws), fl-adulti u tfal 12-il sena u eqdem.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

viatris healthcare limited - fenofibrate, simvastatin - dyslipidemias - aġenti li jimmodifikaw il-lipidi - cholib huwa indikat bħala terapija adjunctive tad-dieta u jeżerċita fir-riskju għoli kardjovaskulari pazjenti adulti ma dyslipidaemia imħallat li tnaqqas it-trigliċeridi u jżidu l-livelli hdl c meta livelli ldl c huma kkontrollati b'mod adegwat bl-doża korrispondenti ta ' l- simvastatin monotherapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

jensonr+ limited - ivabradine hydrochloride - angina pectoris; heart failure - terapija kardijaka - trattament sintomatiku ta 'anġina pectoris stabbli kronika f'adulti b'mard tal-arterja koronarja b'ritmu sinus normali u rata tal-qalb ≥ 70 bpm. ivabradine hija indikata: – fl-adulti ma jistax jittollera jew ma ' kontra-l-indikazzjoni li l-użu ta ' l-beta-blockers - jew fil kombinazzjoni ma beta-blockers fil-pazjenti mhux ikkontrollati b ' doża beta-blocker ottimali. trattament ta ' nuqqas kroniku tal-qalb ivabradine huwa indikat fil-falliment tal-qalb kroniku nyha ii sa iv klassi ma ovarja skjaramenti, fil-pazjenti fl-sinus ritmu u li r-rata tal-qalb huwa ≥ 75 bpm, flimkien ma ' terapija standard inkluża terapija beta-blocker jew meta terapija beta-blocker hija contraindicated jew mhux tollerat.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

viatris limited - ċitrat ta 'sildenafil - pressjoni għolja, pulmonari - uroloġiċi - adultstreatment ta ' pazjenti adulti bi pressjoni għolja arterjali tal-pulmun ikklassifikata bħala klassi funzjonali who ii u iii, biex itejbu l-kapaċità għall-eżerċizzju. l-effikaċja intweriet fl-ipertensjoni primarja pulmonari u pressjoni għolja pulmonari assoċjata ma 'mard tat-tessut konnettiv. pedjatriċi populationtreatment tal-pazjenti pedjatriċi li kellhom minn sena 1 sa 17-il sena bi pressjoni arterjali pulmonari għolja. l-effikaċja f'termini ta 'titjib tal-kapaċità ta' eżerċizzju jew ta 'emodinamiċità pulmonari intweriet fl-ipertensjoni primarja pulmonari u pressjoni għolja pulmonari assoċjata ma' mard tal-qalb konġenitali (ara sezzjoni 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

biomarin international limited - cerliponase alfa - ceroid-lipofuscinoses newronali - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - brineura huwa indikat għall-kura ta newronali ceroid lipofuscinosis tat-tip 2 (cln2) il-marda, magħrufa wkoll bħala tripeptidyl peptidase 1 (tpp1), defiċjenza.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - epatite b, antiġen tal-wiċċ rikombinanti - hepatitis b; immunization - vaċċini - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. l-speċifiċi fil-kategoriji tar-riskju biex jiġu immunizzati għandhom jiġu determinati fuq il-bażi tar-rakkomandazzjonijiet uffiċjali. huwa mistenni li epatite d tiġi evitata wkoll permezz tat-tilqima b'hbvaxpro billi l-epatite d (ikkawżata mill-aġent delta) ma tfeġġx fl-assenza ta ' l-epatite b infezzjoni. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. l-speċifiċi fil-kategoriji tar-riskju biex jiġu immunizzati għandhom jiġu determinati fuq il-bażi tar-rakkomandazzjonijiet uffiċjali. huwa mistenni li epatite d tiġi evitata wkoll permezz tat-tilqima b'hbvaxpro billi l-epatite d (ikkawżata mill-aġent delta) ma tfeġġx fl-assenza ta ' l-epatite b infezzjoni. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. huwa mistenni li epatite d tiġi evitata wkoll permezz tat-tilqima b'hbvaxpro billi l-epatite d (ikkawżata mill-aġent delta) ma sseħħx fin-nuqqas ta ' infezzjoni tal-epatite b.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

omrix biopharmaceuticals n. v. - fibrinoġen uman, trombina umana - hemostasi - lokali hemostatics - trattament ta 'sostenn f'operazjoni adulta fejn it-tekniki kirurġiċi standard mhumiex biżżejjed (ara sezzjoni 5. 1):- għat-titjib ta'l-emostażi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amdipharm limited - zonisamide - epilettiji, parzjali - anti-epilettiċi, - zonegran hu indikat bħala:monoterapija fit-trattament ta 'aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja, fil-adulti li jkunu għadhom kif ġew iddijanjostikati bl-epilessija;terapija aġġuntiva fit-trattament ta' aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja, fil-adulti, l-adoloxxenti u t-tfal ta 'sitt snin u' l fuq.