| Product Information |
DRP-11076_PI_01.pdf
|
| Registration Number |
DRP-11076
|
| Generic Name |
Propofol
|
| Brand Name |
Proanes
|
| Dosage Strength |
10 mg/mL (1% w/v)
|
| Dosage Form |
Emulsion for Injection (I.V./Infusion)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
General Anesthetic (Short-acting Anesthetic)
|
| Packaging |
Type I Clear Borosilicate Glass Ampoule x 20 mL (Box of 5's)
|
| Manufacturer |
PT. Sanbe Farma (Unit 3)
|
| Country of Origin |
Indonesia
|
| Trader |
N/A
|
| Importer |
Caledan Pharma Corp.
|
| Distributor |
Macropharma Corporation
|
| Application Type |
Initial
|
| Issuance Date |
25 January 2022
|
| Expiry Date |
25 January 2027
|