Detailed SMPC and OD register data for: Gazyvaro
Data as extracted from Orphan Designation Register
Product (OD)
Gazyvaro
PL number (OD)
PLGB 00031/0856
OD Designation ID (OD)
OD2
Active substance (OD)
obinutuzumab
Data as extracted from SMPC. (PS: More information at bottom of the page)
Product (SMPC)
PL Number (SMPC)
Composition/ Active Substance (SMPC)
Dose form (SMPC)
Marketing Authorisation holder details (SMPC)
AI match to EMA Substance Dictionary
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SMPC composition / active substance
Matched EMA substance
EMA SMS ID
Confidence
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Further information for:
Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.
OD Indication (OD)
Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1) 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.
Full Designation Number(OD)
PLGB 00031/0856/OD2
Orphan Condition(OD)
Follicular lymphoma (FL)
All Indications (SMPC)
All Contraindications (SMPC)
Warnings/Precautions (SMPC)
Interactions (SMPC)
Pregnancy/Lactation (SMPC)
Driving/Machines (SMPC)
Undesirable effects (SMPC)
Overdose (SMPC)
Shelf life (SMPC)
Storage (SMPC)
Container description (SMPC)
Handling/Disposal (SMPC)
SMPC_URL