| Product Information |
|
| Registration Number |
DR-XY 49015
|
| Generic Name |
Bupivacaine hydrochloride
|
| Brand Name |
Bucain Spinal Heavy
|
| Dosage Strength |
5 mg/mL (0.5% w/v)
|
| Dosage Form |
Solution for Intrathecal Injection
|
| Classification |
Prescription (Rx) Drug
|
| Pharmacologic Category |
Local Anesthetic (Amide)
|
| Packaging |
5 mL capacity Type I clear glass ampoule x 4 mL net content; 1 clear PVC blister containing 5 ampoules (Box of 5 ampoules)
|
| Manufacturer |
PT. Bernofarm
|
| Country of Origin |
Indonesia
|
| Trader |
|
| Importer |
AAA Pharma, Inc.
|
| Distributor |
AAA Pharma, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
05 March 2024
|
| Expiry Date |
08 March 2029
|