| Product Information |
|
| Registration Number |
DRP-13807
|
| Generic Name |
Gemcitabine (as hydrochloride)
|
| Brand Name |
Getanosan 200
|
| Dosage Strength |
200 mg
|
| Dosage Form |
Powder for Solution for Injection (IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
10 mL Type I Clear Glass Vial with Grey Rubber Vial Stopper and Aluminum Flip-off Seal (Box of 1's)
|
| Manufacturer |
PT. Sanbe Farma (Unit 3)
|
| Country of Origin |
Indonesia
|
| Trader |
N/A
|
| Importer |
Macropharma Corporation
|
| Distributor |
Macropharma Corporation
|
| Application Type |
Initial (Correction)
|
| Issuance Date |
28 September 2023
|
| Expiry Date |
26 April 2028
|