LAMZEDE (Chiesi Australia Pty Ltd)
Product name
LAMZEDE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
195 (255 working days)
Active ingredients
velmanase alfa
Registration type
NCE/ NBE
Indication
Enzyme replacement therapy for the treatment of non-central nervous system manifestations in patients with alpha-mannosidosis.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.