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DIMETHYL FUMARATE MSN (Accelagen Pty Ltd)
Product name
DIMETHYL FUMARATE MSN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
149 (255 working days)
Active ingredients
dimethyl fumarate
Registration type
New generic medicine
Indication
DIMETHYL FUMARATE MSN (capsule) is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine