Terrosa Unjoni Ewropea - Malti - EMA (European Medicines Agency)

terrosa

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.

Yervoy Unjoni Ewropea - Malti - EMA (European Medicines Agency)

yervoy

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%.

Orkambi Unjoni Ewropea - Malti - EMA (European Medicines Agency)

orkambi

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - orkambi b'rita huma ndikati għall-kura ta 'fibrożi ċistika (cf) fl-pazjenti ta' bejn 6 snin u ikbar li omozigoti għall-f508del mutazzjoni fil-cftr ġene. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Trisenox Unjoni Ewropea - Malti - EMA (European Medicines Agency)

trisenox

teva b.v. - l-arsenic trioxide - lewkimja, promyelocytic, akuta - aġenti antineoplastiċi - trisenox hu indikat għall-induzzjoni tar-remissjoni u l-konsolidazzjoni f'pazjenti adulti bil:għadhom kif ġew dijanjostikati baxx-intermedja-riskju tal-lewkimja promijeloċitika akuta (apl) (ċelluli bojod tad-demm, ≤ 10 x 103/µl) fil-kombinazzjoni ma'l‑trans‑retinoic acid (atra)li reġgħet tfaċċat/refrattarja-lewkimja promijeloċitika akuta (apl) (t-trattament preċedenti kellha tinkludi xi retinojdi u l-kemoterapija)ikkaratterizzata mill-preżenza ta ' l-t(15;17) traslokazzjoni u/jew il-preżenza tal-pro-myelocytic leukaemia/retinoic acid receptor-alpha (pml/rar-alfa) tal-ġene. ir-rata ta ' rispons ta oħra akuti lewkimja miloġenja-sottotipi għall-arsenic trioxide ma ġew eżaminati.

Opdivo Unjoni Ewropea - Malti - EMA (European Medicines Agency)

opdivo

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.

Olysio Unjoni Ewropea - Malti - EMA (European Medicines Agency)

olysio

janssen-cilag international nv - simeprevir - epatite Ċ, kronika - antivirali għal użu sistemiku - olysio huwa indikat flimkien ma 'prodotti mediċinali oħra għall-kura ta' l-epatite Ċ kronika (chc) f'pazjenti adulti. għall-vajrus tal-epatite Ċ (hcv) ġenotip attività speċifika.

Translarna Unjoni Ewropea - Malti - EMA (European Medicines Agency)

translarna

ptc therapeutics international limited - ataluren - distrofija muskolari, duchenne - mediċini oħra għal disturbi fis-sistema muskoloskeletali - translarna huwa indikat għall-kura ta duchenne distrofija muskolari li jirriżultaw mill-nonsense mutazzjoni fil-ġene dystrophin, fil-ambulatorja l-pazjenti fl-etajiet ta'2-il sena u anzjani. l-effikaċja ma ntwerietx li mhumiex fl-pazjenti ambulatorji. il-preżenza ta nonsense mutazzjoni fil-ġene dystrophin għandhom jiġu determinati mill-ġenetika tal-ittestjar.

Zostavax Unjoni Ewropea - Malti - EMA (European Medicines Agency)

zostavax

merck sharp & dohme b.v. - virus varicella-zoster (ħaj, attenwat) - herpes zoster; immunization - vaċċini virali - zostavax huwa indikat għall-prevenzjoni ta 'herpes zoster (' zoster 'jew ħruq ta' sant'antnin) u nevralġija post-herpetika relatata ma 'herpes-zoster. zostavax huwa indikat għall-immunizzazzjoni ta'individwi ta'50 sena jew akbar fl-età.

Sylvant Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sylvant

recordati netherlands b.v. - siltuximab - iperplażja tal-node tal-linfoma Ġigant - immunosoppressanti - sylvant huwa indikat għall-kura tal-pazjenti adulti bil-marda tal-castleman multicentric (mcd li huma negattivi negattivi u l-bniedem herpesvirus-8 (hhv-8) immunodefiċjenza umani virus (hiv).

PritorPlus Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pritorplus

bayer ag - telmisartan, hydrochlorothiazide - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali. pritorplus kombinazzjoni b'doża fissa (40 mg telmisartan / 12. 5 mg hydrochlorothiazide, 80mg telmisartan / 12. 5 mg ta ' hydrochlorothiazide) hi indikata f'pazjenti li l-pressjoni tad-demm ma tkunx ikkontrollata sew b'telmisartan waħdu. pritorplus kombinazzjoni b'doża fissa (80 mg telmisartan / 25 mg hydrochlorothiazide) hi indikata f'pazjenti li l-pressjoni tad-demm ma tkunx ikkontrollata adegwatament fuq pritorplus (80 mg telmisartan / 12. 5 mg hydrochlorothiazide) jew f'pazjenti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.