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Detailed SMPC and OD register data for: IMDYLLTRA 1 milligram and 10mg powder for concentrate and solution for infusion

Data as extracted from Orphan Designation Register

Product (OD)
IMDYLLTRA 1 milligram and 10mg powder for concentrate and solution for infusion
PL number (OD)
PLGB 13832/0083
OD Designation ID (OD)
OD1
Active substance (OD)
TARLATAMAB

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)
For the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at least two prior lines of therapy including platinum-based chemotherapy
Full Designation Number(OD)
PLGB 13832/0083-0084/OD1
Orphan Condition(OD)
Small cell lung cancer
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