Euroopan unioni - italia - 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 - agenti antineoplastici - 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.

Sveitsi - italia - Swissmedic (Swiss Agency for Therapeutic Products)

sandoz pharmaceuticals ag - trimipraminum - gocce per uso orale, soluzione - trimipraminum 40 mg ut trimipramini mesilas, polysorbatum 80, natrii laurilsulfas corresp. natrium max. 0.1994 mg, ethanolum 96 per centum 100 mg, menthae piperitae aetheroleum, aqua purificata, ad solutionem pro 1 ml corresp. ethanolum 12 % v/v. - antidepressivo - synthetika

Sveitsi - italia - Swissmedic (Swiss Agency for Therapeutic Products)

merck (schweiz) ag - metforminum - compresse rivestite con film - metformini hydrochloridum 500.0 mg corrisp. metformin 390.0 mg, povidonum k 30, magnesii stearas, placcatura: hypromellosum pro compresso obducto. - farmaco antidiabetico orale - synthetika

Sveitsi - italia - Swissmedic (Swiss Agency for Therapeutic Products)

merck (schweiz) ag - metforminum - compresse rivestite con film - metformini hydrochloridum 850.0 mg corrisp. metformin 662.9 mg, povidonum k 30, magnesii stearas, placcatura: hypromellosum pro compresso obducto. - farmaco antidiabetico orale - synthetika

Sveitsi - italia - Swissmedic (Swiss Agency for Therapeutic Products)

merck (schweiz) ag - metformini hydrochloridum - compresse rivestite con film - metformini hydrochloridum 1000.0 mg corrisp. metforminum 780.0 mg, povidonum k 30, magnesio stearas, Überzug: hypromellosum, macrogolum 400, macrogolum 8000 per compresso haze. - farmaco antidiabetico orale - synthetika

Euroopan unioni - italia - EMA (European Medicines Agency)

virbac s.a. - alofuginone - antiprotozoari - vitelli, neonati - in new born calves:- prevention of diarrhoea due to diagnosed cryptosporidium parvum, in farms with history of cryptosporidiosis,administration should start in the first 24 to 48 hours of age- reduction of diarrhoea due to diagnosed cryptosporidium parvum. l'amministrazione dovrebbe iniziare entro 24 ore dall'esordio della diarrea. in entrambi i casi è stata dimostrata la riduzione dell'escrezione di oocisti.

Italia - italia - Ministero della Salute

laboratorios karizoo s.a. - halofuginone lactate - orale - halofuginone lactate - nd, alofuginone 0,5 mg/ml - halofuginone - vitelli

Italia - italia - Ministero della Salute

ceva salute animale s.p.a. - clindamicina cloridrato - clindamicina cloridrato - 27.15 mg - clindamycin

Sveitsi - italia - Swissmedic (Swiss Agency for Therapeutic Products)

chiesi sa - beclometasoni dipropionas, formoteroli fumaras dihydricus, glycopyrronium - solution pour inhalation en flacon pressurisé - beclometasoni dipropionas 87.4 µg, formoteroli fumaras dihydricus 5.2 µg, glycopyrronii bromidum 10.9 µg corresp. glycopyrronium 9 µg, ethanolum anhydricum 8.856 mg, acidum hydrochloridum, norfluranum, ad aerosolum, pro dosi. - bronchopneumopathie chronique obstructive (bpco) (trimbow 87/5/9 mcg), asthme (trimbow 172/5/9 mcg) - synthetika

Sveitsi - italia - Swissmedic (Swiss Agency for Therapeutic Products)

chiesi sa - beclometasoni dipropionas, formoteroli fumaras dihydricus, glycopyrronium - solution pour inhalation en flacon pressurisé - beclometasoni dipropionas 172.3 µg, formoteroli fumaras dihydricus 5 µg, glycopyrronii bromidum 10.6 µg corresp. glycopyrronium 9 µg, ethanolum anhydricum 8.856 mg, acidum hydrochloridum, norfluranum, ad aerosolum, pro dosi. - bronchopneumopathie chronique obstructive (bpco) (trimbow 87/5/9 mcg), asthme (trimbow 172/5/9 mcg) - synthetika