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RADICAVA (Teva Pharma Australia Pty Ltd)
Product name
RADICAVA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
192 (255 working days)
Active ingredients
edaravone
Registration type
NCE/NBE
Indication
RADICAVA is indicated in adults with a diagnosis of amyotrophic lateral sclerosis who are independent in activities of daily living with normal respiratory function and where treatment is initiated within two years of disease onset.
Efficacy has not been demonstrated in patients outside of this defined population.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.