Detailed SMPC and OD register data for: Vyloy
Data as extracted from Orphan Designation Register
Product (OD)
Vyloy
PL number (OD)
PLGB 00166/0439
OD Designation ID (OD)
OD1
Active substance (OD)
zolbetuximab
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
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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)
Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 -negative gastric or gastro-oesophageal junction adenocarcinoma whose tumours are Claudin 18.2 positive
Full Designation Number(OD)
PLGB 00166/0439/OD1
Orphan Condition(OD)
Malignant neoplasm of stomach
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