NIMODIPINE JUNO (Juno Pharmaceuticals Pty Ltd)
Product name
NIMODIPINE JUNO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
141 (255 working days)
Active ingredients
nimodipine
Registration type
New generic medicine
Indication
NIMODIPINE JUNO (intravenous infusion for injection) is indicated for prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm after subarachnoid haemorrhage following ruptured intracranial aneurysm, in patients who are in good neurological condition post-ictus, e.g. Hunt and Hess Grades I-III (see section 5.1 Pharmacodynamic properties).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine