R RegData
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Application Reference Reason

Reason for referencing another application within a submission (e.g. cross-reference to a DMF or related dossier). Regionally defined.

eCTD 4.0 Application Reference Reason 2 terms
All agencies EMA
Term Code Agency Status
Reference Medicinal Product (for Data Protection Period) 100000155052 EMA Active
Reference Medicinal Product (for Bioequivalence) 100000155053 EMA Active

2 terms shown for EMA. Data sourced from public health authority publications and updated periodically.