Excellent
Aligned
Patient Risk:
Low
Summary
All provided claims that NUBEQA’s active ingredient is darolutamide are supported by the label excerpts (Drug name/active ingredient context and Mechanism of Action stating Darolutamide as the androgen receptor inhibitor). No contradictions or omissions detected for these statements.
Category Scores
Accurate Statements
Nubeqa’s generic name is darolutamide.
Label provided identifies the active ingredient as darolutamide and states in Mechanism of Action that darolutamide is the androgen receptor inhibitor (12.1).
For Nubeqa, darolutamide is the active ingredient.
Label provided under Drug/Active ingredient(s) specifies NUBEQA active ingredient: darolutamide, and label text repeatedly refers to darolutamide in pharmacology (12.1) and pharmacokinetics (12.3).
The active pharmaceutical ingredient in Nubeqa remains darolutamide.
Same basis as above: label identifies darolutamide as the active ingredient and uses darolutamide throughout clinical pharmacology (12.1, 12.3).
Unsupported Statements
Contradictions
Important Omissions
Safety Assessment
Potential Patient Risk:
Low
The evaluated claims are identity statements about the drug’s active ingredient and do not assert dosing, use, or safety actions.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Aligned
Primary Issue
Suggested Improvement