| Product Information |
DR-XY47947_PI_01.pdf
|
| Registration Number |
DR-XY47947
|
| Generic Name |
Gemcitabine
|
| Brand Name |
Gemcilex
|
| Dosage Strength |
1 g
|
| Dosage Form |
Powder for Injection (IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic (Pyrimidine analogues)
|
| Packaging |
USP Type I colorless glass vials sealed with gray bromobutyl rubber stopper and aluminum seal with flip-off cap x 1 mL (Box of l’s)
|
| Manufacturer |
Laboratorio Kemex S.A.
|
| Country of Origin |
Argentine Republic
|
| Trader |
|
| Importer |
Delex Pharma International, Inc.
|
| Distributor |
Delex Pharma International, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
20 April 2022
|
| Expiry Date |
20 April 2027
|