MHRA Data Portal — Proof of Concept
← Back to Orphan Designations

Detailed SMPC and OD register data for: Qarziba

Data as extracted from Orphan Designation Register

Product (OD)
Qarziba
PL number (OD)
PLGB 44185/0005
OD Designation ID (OD)
OD1
Active substance (OD)
dinutuximab beta Chimeric monoclonal antibody against GD2

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

We analysed the SMPC composition text and searched for the closest equivalent in EMA's published substance dictionary. The suggested match and supporting details are shown below.

SMPC composition / active substance
Matched EMA substance
EMA SMS ID
Confidence
Higher confidence means the match is more likely to be correct.
Show AI rationale

Further information for:

Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.

OD Indication (OD)
Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin-2 (IL-2).
Full Designation Number(OD)
PLGB 44185/0005/OD1
Orphan Condition(OD)
Neuroblastoma
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

Link to SMPC: Not available