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ROMIDEPSIN-MSN, ROMIDEPSIN-REACH (Reach Pharmaceuticals Pty Ltd)
Product name
ROMIDEPSIN-MSN, ROMIDEPSIN-REACH
Sponsor
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