ইউরোপীয় ইউনিয়ন - মল্টিয় - EMA (European Medicines Agency)

stada arzneimittel ag - 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 - oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. oyavas 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. oyavas 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 oyavas in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. oyavas, 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. oyavas, 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. oyavas in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. oyavas, 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. oyavas, 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. oyavas, in combination with 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. oyavas, 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.

ইউরোপীয় ইউনিয়ন - মল্টিয় - EMA (European Medicines Agency)

akebia europe limited - kumpless ta 'koordinazzjoni taċ-ċitrat ferriku - hyperphosphatemia; renal dialysis - drogi għat-trattament ta 'iperkalimja u iperfosfatemija - fexeric huwa indikat għall-kontroll ta 'iperfosfatemija f'pazjenti adulti b'mard kroniku tal-kliewi (ckd).

ইউরোপীয় ইউনিয়ন - মল্টিয় - EMA (European Medicines Agency)

sanofi b.v. - sevelamer - renal dialysis; hyperphosphatemia - il-prodotti terapewtiċi l-oħra kollha - renagel is indicated for the control of hyperphosphataemia in adult patients receiving  haemodialysis or peritoneal dialysis. renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy vitamin d3 or one of its analogues to control the development of renal bone disease.

ইউরোপীয় ইউনিয়ন - মল্টিয় - 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.

ইউরোপীয় ইউনিয়ন - মল্টিয় - EMA (European Medicines Agency)

incline therapeutics europe ltd - fentanyl hydrochloride - uġigħ, wara l-operazzjoni - analġeżiċi - ionsys huwa indikat għall-immaniġġjar ta 'uġigħ akut post-operattiv moderat għal sever f'pazjenti adulti.

ইউরোপীয় ইউনিয়ন - মল্টিয় - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - lopinavir, ritonavir - infezzjonijiet ta 'hiv - antivirals for systemic use, protease inhibitors - kaletra huwa indikat flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' adulti infettati bil-virus tal-immunodefiċjenza umana (hiv-1), adolexxenti u tfal ta '14-il jum jew aktar. l-għażla ta 'kaletra għall-kura ta' impedituri protease tal-hiv-1 f'pazjenti infettati għandha tkun ibbażata fuq testijiet tar-reżistenza virali u l-istorja tat-trattament tal-pazjenti.

ইউরোপীয় ইউনিয়ন - মল্টিয় - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

ইউরোপীয় ইউনিয়ন - মল্টিয় - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - aġenti antineoplastiċi - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4. 4 u 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.

ইউরোপীয় ইউনিয়ন - মল্টিয় - EMA (European Medicines Agency)

h. lundbeck a/s - nalmefene hydrochloride dihydrate - disturbi relatati ma 'l-alkoħol - drogi użati fid-dipendenza fuq l-alkoħol - selincro huwa indikat għat-tnaqqis tal-konsum ta 'alkoħol f'pazjenti adulti b'dipendenza alkoħolika li għandhom livell għoli ta' riskju ta 'xorb (ara sezzjoni 5. 1), mingħajr sintomi ta 'rtirar fiżiku u li ma jeħtiġux ditossifikazzjoni immedjata. selincro għandhom jiġu biss preskritti flimkien mal-kontinwu appoġġ psikosoċjali ffukat fuq it-trattament aderenza u t-tnaqqis tal-konsum tal-alkoħol. selincro għandu jinbeda biss f'pazjenti li jkomplu jkollhom għoli tax-xorb il-livell ta'riskju ġimagħtejn wara l-valutazzjoni inizjali.

ইউরোপীয় ইউনিয়ন - মল্টিয় - EMA (European Medicines Agency)

genzyme europe bv - sevelamer hydrochloride - hyperphosphatemia; renal dialysis - il-prodotti terapewtiċi l-oħra kollha - il-karatteristika hija indikata għall-kontroll ta 'iperfosfatemija f'pazjenti adulti li qed jirċievu emodijalisi jew dijalisi peritoneali. sevelamer hydrochloride għandhom jiġu użati fil-kuntest ta ' multipli terapewtiċi approċċ, li jistgħu jinkludu supplimenti tal-kalċju, dihydroxy 1,25 vitamina d3 jew waħda minn tiegħu analogi biex tikkontrolla l-iżvilupp tal-marda ta ' l-għadam renali.