PFIZER BUPIVACAINE, BUPIVADREN (Pfizer Australia Pty Ltd)
Product name
PFIZER BUPIVACAINE, BUPIVADREN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
214 working days (255)
Active ingredients
bupivacaine hydrochloride monohydrate; adrenaline (epinephrine) acid tartrate
Registration type
New generic medicine
Indication
PFIZER BUPIVACAINE, BUPIVADREN (injection) is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows:
Surgical anaesthesia
- Epidural block for surgery
- Field block (minor and major nerve blocks and infiltration)
Analgesia
- Continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain
- Field block (minor nerve block and infiltration)
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine