PARECOXB, PARECOX, PARECOXIB JPL, PARECOXIB-APOTEX (Neo Health (Australia) Pty Ltd)
Product name
PARECOXB, PARECOX, PARECOXIB JPL, PARECOXIB-APOTEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
217 working days (255)
Active ingredients
Parecoxib sodium
Registration type
New generic medicine
Indication
PARECOXB, PARECOX, PARECOXIB JPL, PARECOXIB-APOTEX (powder for injection) is indicated for a single per-operative dose for the management of post-operative pain.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine