Finlandia - finés - Fimea (Suomen lääkevirasto)

glenmark arzneimittel gmbh - azacitidine - injektiokuiva-aine, suspensiota varten - 25 mg/ml - atsasitidiini

Unión Europea - finés - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - selektiiviset immunosuppressantit - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Finlandia - finés - Fimea (Suomen lääkevirasto)

laboratorios lorien s.l. - caspofungin acetate - kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos - 50 mg - kaspofungiini

Finlandia - finés - Fimea (Suomen lääkevirasto)

laboratorios lorien s.l. - caspofungin acetate - kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos - 70 mg - kaspofungiini

Unión Europea - finés - EMA (European Medicines Agency)

janssen-cilag international nv - darunaviiria - hiv-infektiot - antiviraalit systeemiseen käyttöön - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Finlandia - finés - Fimea (Suomen lääkevirasto)

actavis group ptc ehf - remifentanili hydrochloridum - kuiva-aine välikonsentraatiksi injektio-/infuusionestettä varten, liuos - 1 mg - remifentaniili

Finlandia - finés - Fimea (Suomen lääkevirasto)

actavis group ptc ehf - remifentanili hydrochloridum - kuiva-aine välikonsentraatiksi injektio-/infuusionestettä varten, liuos - 2 mg - remifentaniili

Finlandia - finés - Fimea (Suomen lääkevirasto)

actavis group ptc ehf - remifentanili hydrochloridum - kuiva-aine välikonsentraatiksi injektio-/infuusionestettä varten, liuos - 5 mg - remifentaniili

Finlandia - finés - Fimea (Suomen lääkevirasto)

pfizer pfe finland oy - remifentanili hydrochloridum - kuiva-aine välikonsentraatiksi injektio-/infuusionestettä varten, liuos - 1 mg - remifentaniili

Finlandia - finés - Fimea (Suomen lääkevirasto)

pfizer pfe finland oy - remifentanili hydrochloridum - kuiva-aine välikonsentraatiksi injektio-/infuusionestettä varten, liuos - 2 mg - remifentaniili