Euroopan unioni - suomi - EMA (European Medicines Agency)

pharmathen s.a. - ibandronihappo - hypercalcemia; fractures, bone; neoplasm metastasis; breast neoplasms - lääkkeet luusairauksien hoitoon - concentrate for solution for infusion prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. kasvainten aiheuttaman hyperkalsemian hoitoon tai ilman etäpesäkkeitä. film-coated tablets prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Euroopan unioni - suomi - 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 - antineoplastiset aineet - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - verteporfiini - myopia, degenerative; macular degeneration - silmätautien - visudyne on tarkoitettu hoitoon:aikuisille, joilla on exudative (märkä) ikään liittyvä silmänpohjan rappeuma (amd), joilla oli pääasiassa klassinen foveanalaisen suonikalvon uudissuonittumisesta (cnv); tai aikuiset, jotka potevat foveanalaista suonikalvon uudissuonittumista toissijainen patologinen myopia.

Suomi - suomi - Fimea (Suomen lääkevirasto)

recordati industria chimica e farmaceutica s.p.a. - leuprorelin acetate - injektiokuiva-aine ja liuotin, liuosta varten - 7.5 mg - leuproreliini

Suomi - suomi - Fimea (Suomen lääkevirasto)

recordati industria chimica e farmaceutica s.p.a. - leuprorelin acetate - injektiokuiva-aine ja liuotin, liuosta varten - 22.5 mg - leuproreliini

Suomi - suomi - Fimea (Suomen lääkevirasto)

recordati industria chimica e farmaceutica s.p.a. - leuprorelin acetate - injektiokuiva-aine ja liuotin, liuosta varten - 45 mg - leuproreliini

Euroopan unioni - suomi - EMA (European Medicines Agency)

accord healthcare s.l.u. - leuprorelin mesilate - prostatiset kasvaimet - endokriinihoito - camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

Euroopan unioni - suomi - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - inaktivoitu, influenssavirus, joka sisältää antigeenia: a / vietnam / 1194/2004 (h5n1), kuten käytetty kanta (nibrg-14) - influenza, human; immunization; disease outbreaks - rokotteet - aktiivinen immunisaatio influenssa a -viruksen h5n1-alatyypin suhteen. tämä käyttöaihe perustuu immunogeenisuutta terveillä henkilöillä, ikä 18 vuotta alkaen annon jälkeen kaksi annosta rokotetta valmistaa a/vietnam/1194/2004 nibrg-14 (h5n1) (ks. kohta 5. prepandemiainfluenssarokote (h5n1) (virusfragmentit, inaktivoitu, adjuvanttia sisältävä rokote) glaxosmithkline biologicals 3. 75 µg tulee käyttää virallisen ohjeistuksen mukaisesti.

Euroopan unioni - suomi - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - inaktivoitu, influenssavirus, joka sisältää antigeenia: a / vietnam / 1194/2004 (h5n1), kuten käytetty kanta (nibrg-14) - influenza, human; immunization; disease outbreaks - rokotteet - influenssan ennaltaehkäisy virallisesti ilmoitetussa pandemiatilanteessa. pandemian influenssarokote on käytettävä virallisten ohjeiden mukaisesti.

Euroopan unioni - suomi - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenssa virus, inaktivoitu, sisältää antigeenia*: a/california/7/2009 (h1n1)v-kaltainen kanta (x-179a)*tuotettu kananmunissa. - influenza, human; immunization; disease outbreaks - influenssarokot - influenssan ennaltaehkäisy virallisesti ilmoitetussa pandemiatilanteessa. pandemian influenssarokote on käytettävä virallisten ohjeiden mukaisesti.