AZALINE, AZIGILINE, ASAGILINE, RASAZILECT, RASAGILINE MYLAN, RASAGILINE GPPL, RASAGILINE GXP (Generic Partners Pty Ltd)
Product name
AZALINE, AZIGILINE, ASAGILINE, RASAZILECT, RASAGILINE MYLAN, RASAGILINE GPPL, RASAGILINE GXP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
174 working days (255)
Active ingredients
rasagiline mesilate
Registration type
New generic medicine
Indication
AZALINE, AZIGILINE, ASAGILINE, RASAZILECT, RASAGILINE MYLAN, RASAGILINE GPPL, RASAGILINE GXP (tablets) is indicated for the symptomatic treatment of idiopathic Parkinson's disease (PD) as monotherapy (without concomitant levodopa , decarboxylase inhibitor therapy) or as adjunct therapy (with concomitant levodopa , decarboxylase inhibitor therapy).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine