Van professionele vertalers, bedrijven, webpagina's en gratis beschikbare vertaalbronnen.
optimized out
itemized list
Laatste Update: 2014-10-08
Gebruiksfrequentie: 1
Kwaliteit:
rizinate optimized is een zeer krachtig zoethoutextract dat niet moet gekauwd worden voor een effectief resultaat.
rizinate is a very powerful licorice extract that does not need to be chewed for an effective result.
omschrijving ter ondersteuning van de risico-voordeelafweging heeft de aanvrager de chmp gegevens over veiligheid en werkzaamheid na 48 weken uit het lopende fase iii-protocol 018 (a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of mk-0518 in combination with an optimized background therapy (obt), versus optimized background therapy alone, in hiv-infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies) en protocol 019 (a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of mk-0518 in combination with an optimized background therapy (obt), versus optimized background therapy alone, in hiv- infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies) ter beoordeling voorgelegd.
description to further support the benefit risk assessment, the mah has provided the chmp with the 48-week safety and efficacy data from the ongoing phase iii protocol 018 (a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of mk-0518 in combination with an optimized background therapy (obt), versus optimized background therapy alone, in hiv- infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies) and protocol 019 (a multicenter, double-blind, randomized, placebo- controlled study to evaluate the safety and antiretroviral activity of mk-0518 in combination with an optimized background therapy (obt), versus optimized background therapy alone, in hiv-infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies) for review.
