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Detailed SMPC and OD register data for: Oxlumo

Data as extracted from Orphan Designation Register

Product (OD)
Oxlumo
PL number (OD)
PLGB 50597/0005
OD Designation ID (OD)
OD1
Active substance (OD)
lumasiran Synthetic double-stranded siRNA oligonucleotide directed against hydroxyacid oxidase 1 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues

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.
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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)
Oxlumo is indicated for the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.
Full Designation Number(OD)
PLGB 50597/0005/OD1
Orphan Condition(OD)
Primary hyperoxaluria
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