Union européenne - français - EMA (European Medicines Agency)

astrazeneca ab - anifrolumab - lupus érythémateux, systémique - immunosuppresseurs - 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.

Canada - français - Health Canada

astrazeneca canada inc - anifrolumab - solution - 150mg - anifrolumab 150mg

Suisse - français - Swissmedic (Swiss Agency for Therapeutic Products)

astrazeneca ag - anifrolumabum - solution à diluer pour perfusion - anifrolumabum 300 mg, histidinum, histidini hydrochloridum monohydricum, lysini hydrochloridum, trehalosum dihydricum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 2 ml. - le lupus érythémateux disséminé (sle) - biotechnologika

Union européenne - français - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - carcinome, poumon non à petites cellules - antinéoplasiques et agents immunomodulateurs, des anticorps monoclonaux - nivolumab bms est indiqué pour le traitement du cancer du poumon non à petites cellules squameux localement avancé ou métastatique (nsclc) après une chimiothérapie chez l'adulte.

Union européenne - français - 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 - agents antinéoplasiques - 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.

Suisse - français - Swissmedic (Swiss Agency for Therapeutic Products)

bristol-myers squibb sa - relatlimabum, nivolumabum - solution à diluer pour perfusion - relatlimabum 80 mg, nivolumabum 240 mg, histidinum, histidini hydrochloridum monohydricum, saccharum, polysorbatum 80, acidum penteticum, aqua ad iniectabile ad solutionem pro 20 ml. - fortgeschrittenes melanom - biotechnologika

Union européenne - français - EMA (European Medicines Agency)

sanofi winthrop industrie - alirocumab - dyslipidémies - agents de modification des lipides - hypercholestérolémie primaire et mixtes dyslipidaemiapraluent est indiqué chez les adultes atteints d'hypercholestérolémie primaire (familiale hétérozygote et non familiale) ou des dyslipidémies mixtes, en complément du régime alimentaire:en association avec une statine ou d'une statine avec d'autres hypolipidémiants thérapies chez les patients incapables d'atteindre un taux de ldl-c objectifs avec la dose maximale tolérée de statine ou,seul ou en combinaison avec d'autres hypolipidémiants thérapies chez les patients qui prennent des statines intolérants, ou pour lesquels une statine est contre-indiqué. Établi de la maladie cardiovasculaire athéroscléreuse praluent est indiqué chez les adultes ayant établi les maladies cardiovasculaires athérosclérotiques pour réduire le risque cardiovasculaire en abaissant le taux de cholestérol ldl, comme complément de la correction des autres facteurs de risque:en combinaison avec la dose maximale tolérée de statine avec ou sans d'autres hypolipidémiants ou des traitements,seul ou en combinaison avec d'autres hypolipidémiants thérapies chez les patients qui prennent des statines intolérants, ou pour lesquels une statine est contre-indiqué. pour les résultats de l'étude concernant les effets sur le taux de ldl-c, les événements cardiovasculaires et les populations étudiées, voir la section 5.

Suisse - français - Swissmedic (Swiss Agency for Therapeutic Products)

sanofi-aventis (suisse) sa - alirocumabum - solution pour injection en seringue pré-remplie - solution: alirocumabum 75 mg, histidini hydrochloridum monohydricum, histidinum, saccharum, polysorbatum 20, aqua ad iniectabile ad solutionem pro 1 ml. - hypolipémiants - biotechnologika

Suisse - français - Swissmedic (Swiss Agency for Therapeutic Products)

sanofi-aventis (suisse) sa - alirocumabum - solution pour injection en seringue pré-remplie - solution: alirocumabum 150 mg, histidini hydrochloridum monohydricum, histidinum, saccharum, polysorbatum 20, aqua ad iniectabile ad solutionem pro 1 ml. - hypolipémiants - biotechnologika

Suisse - français - Swissmedic (Swiss Agency for Therapeutic Products)

sanofi-aventis (suisse) sa - alirocumabum - solution pour injection dans un stylo pré-rempli - solution: alirocumabum 75 mg, histidini hydrochloridum monohydricum, histidinum, saccharum, polysorbatum 20, aqua ad iniectabile ad solutionem pro 1 ml. - hypolipémiants - biotechnologika