On 28 April 2016, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product obinutuzumab (Gazyvaro).The marketing authorisation holder for this medicinal product is Roche Registration Limited.
The CHMP adopted a new indication as follows: Follicular Lymphoma (FL)
Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. Read more here.
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