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ROMIDEPSIN-MSN, ROMIDEPSIN-REACH (Reach Pharmaceuticals Pty Ltd)

Product name
ROMIDEPSIN-MSN, ROMIDEPSIN-REACH
Sponsor
Reach Pharmaceuticals Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
133 (255 working days)
Active ingredients
Romidepsin
Registration type
New generic medicine
Indication

ROMIDEPSIN-MSN, ROMIDEPSIN-REACH is indicated for the treatment of peripheral T-cell lymphoma in patients who have received at least one prior systemic therapy.

Registration process

First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine

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