EMA Authorised: Darzalex (daratumumab) — Janssen-Cilag International N.V.

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Summary

The EMA authorised Darzalex (daratumumab) by Janssen-Cilag International N.V. for multiple myeloma, with orphan medicine status and accelerated assessment.

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Diseases / indications

• Multiple Myeloma

Drugs mentioned

• DARZALEX (daratumumab)

Snippet

Status: Authorised. Therapeutic area: Multiple Myeloma. MAH: Janssen-Cilag International N.V.. Decision date: 05/02/2026. Orphan medicine. Accelerated assessment