Unia Europejska - maltański - EMA (European Medicines Agency)

laboratorios hipra, s.a. - verotoxin 2e rikombinanti ta 'e. coli - inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium, immunologicals for suidae - majjali - immunizzazzjoni attiva ta 'ħnieżer minn jumejn biex tevita l-mortalità u tnaqqas sinjali kliniċi ta' mard ta 'edema (ikkawżat minn verotossina 2e prodotta minn e. coli) u biex jitnaqqas it-telf ta 'żieda fil-piż ta' kuljum matul il-perjodu ta 'l-irfinar quddiem infezzjonijiet bil-verotossina 2e li tipproduċi e. coli sal-qatla mill-età ta '164 jum.

Unia Europejska - maltański - EMA (European Medicines Agency)

novartis europharm limited  - alpelisib - neoplażmi tas-sider - aġenti antineoplastiċi - piqray huwa indikat, flimkien ma 'fulvestrant għall-kura ta' nisa wara l-menopawża, u l-irġiel, bl-ormon tat-riċettur (hr)-pożittivi, tal-bniedem tar-riċettur tal-fattur tat-tkabbir epidermali 2 (her2)-negattivi, lokalment avvanzat jew dak metastatiku-kanċer tas-sider bil-pik3ca mutazzjoni wara l-progressjoni tal-marda wara l-terapija endokrinali bħala monoterapija (ara sezzjoni 5.

Unia Europejska - maltański - EMA (European Medicines Agency)

astrazeneca ab - anifrolumab - lupus eritematoso, sistemiku - immunosoppressanti - saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (sle), despite standard therapy.

Unia Europejska - maltański - EMA (European Medicines Agency)

elanco gmbh - spinosad - oħra ektoparasitaċidali għall-użu sistemiku - dogs; cats - trattament u prevenzjoni ta 'infestazzjonijiet tal-briegħed (ctenocephalides felis). l-effett preventiv kontra l-infestazzjonijiet mill-ġdid huwa riżultat tal-attività tal-adulti u t-tnaqqis fil-produzzjoni tal-bajd u jippersisti sa 4 ġimgħat wara amministrazzjoni waħda tal-prodott. il-prodott mediċinali veterinarju jista 'jintuża bħala parti minn strateġija tat-trattament għall-kontroll ta' dermatite allerġika tal-bergħud (fad).

Unia Europejska - maltański - EMA (European Medicines Agency)

gedeon richter plc. - teriparatide - l-osteoporożi - homeostasi tal-kalċju - terrosa hija indikata fl-adulti. trattament ta 'l-osteoporożi f'nisa wara l-menopawża u fl-irġiel b'riskju akbar ta' ksur. f'nisa wara l-menopawża, intwera tnaqqis sinifikanti fl-inċidenza ta 'ksur vertebrali u mhux vertebrali iżda mhux fratturi tal-ġenbejn. trattament ta 'osteoporożi assoċjat ma sostnut sistemika terapija bi glukokortikojdi f'nisa u l-irġiel f'riskju akbar ta' ksur.

Unia Europejska - maltański - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - aġenti antineoplastiċi - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. 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. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab 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. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab 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. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab 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%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy 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%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Unia Europejska - maltański - EMA (European Medicines Agency)

strides pharma (cyprus) limited - teriparatide - osteoporosis; osteoporosis, postmenopausal - homeostasi tal-kalċju - kauliv is indicated in adults. treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.

Unia Europejska - maltański - EMA (European Medicines Agency)

janssen-cilag international n.v. - abiraterone acetate - neoplasmi prostatiċi - terapija endokrinali - zytiga huwa indikat ma 'prednisone jew prednisolone: - trattament tal-kanċer metastatiku tal-kastrazzjoni reżistenti għall-kanċer tal-prostata fl-irġiel adulti li huma asintomatiċi jew ħafif sintomatika wara l-falliment tat-terapija tal-privazzjoni tal-androgen fil-għalihom kimoterapija għadu mhux klinikament indicatedthe-trattament tal-kanċer metastatiku tal-kastrazzjoni reżistenti għall-kanċer tal-prostata fl-irġiel adulti li l-marda tagħhom mexa fuq jew wara docetaxel kimoterapija bbażata fuq il-kors ta'.

Unia Europejska - maltański - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; wegener granulomatosis; leukemia, lymphocytic, chronic, b-cell; microscopic polyangiitis - aġenti antineoplastiċi - truxima huwa indikat fl-adulti għall-indikazzjonijiet li ġejjin:mhux ta 'hodgkin (nhl)truxima huwa indikat għall-kura ta' pazjenti mhux trattati qabel ma l-istadju iii-iv limfoma follikulari flimkien mal-kimoterapija. truxima terapija ta 'manteniment huwa indikat għat-trattament tal-linfoma follikulari-pazjenti li jirrispondu għal terapija ta' induzzjoni. truxima monoterapija hija indikata għat-trattament ta 'pazjenti b'stadju iii-iv limfoma follikulari li huma kemo reżistenti jew li qegħdin fit-tieni jew aktar episodju ta' rkadar wara kimoterapija. truxima huwa indikat għall-kura ta 'pazjenti bil-tixrid pożittiv cd20 taċ-ċelluli b kbar mhux ta' hodgkin il-limfoma f'kombinazzjoni ma ' chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) l-kimoterapija. lewkimja limfoċitika kronika (cll)truxima flimkien ma 'kimoterapija huwa indikat għat-trattament ta' pazjenti li ma kienux trattati qabel u li reġgħet tfaċċat/refrattarja cll. hija disponibbli biss informazzjoni limitata dwar l-effikaċja u s-sigurtà għal pazjenti li qabel kienu kkurati b'antikorpi monoklonali inkluż truxima jew pazjenti refrattarji għal kemjoterapija ta 'truxima plus preċedenti. rewmatika arthritistruxima flimkien ma 'methotrexate huwa indikat għall-kura ta' pazjenti adulti b' ' l-artrite rewmatika attiva severa li kellhom rispons inadegwat jew intolleranza għal oħra li timmodifika l-marda anti rewmatiċi-mediċini (dmard) fosthom wieħed jew aktar tal-fattur tan-nekrożi tat-tumur (tnf) inibitur terapiji. truxima ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. granulomatosi b'polianġite u mikroskopika polyangiitistruxima, flimkien ma 'glukokortikosterojdi, huwa indikat għall-kura ta' pazjenti adulti b'mard sever, attiv granulomatosi b'polianġite (wegener tal) (fap) u polianġite mikroskopika (mpa). pemphigus vulgaristruxima huwa indikat għall-kura ta ' pazjenti b'indeboliment moderat jew sever tal-pemphigus vulgaris (pv).

Unia Europejska - maltański - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - thalidomide - majloma multipla - immunosoppressanti - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.