| Product Information |
|
| Registration Number |
DRP-11675
|
| Generic Name |
Gemcitabine (As Hydrochloride)
|
| Brand Name |
Gemaccord 1500
|
| Dosage Strength |
100mg/mL (1.5g/15mL)
|
| Dosage Form |
Concentrate for Solution for IV Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic (Pyrimidine analogues)
|
| Packaging |
Type I Clear Glass Vial x 15 mL with red flip-off seal (Box of l's)
|
| Manufacturer |
Intas Pharmaceuticals Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Accord Healthcare Limited - Philippine Branch Office
|
| Distributor |
N/A
|
| Application Type |
Initial
|
| Issuance Date |
13 April 2022
|
| Expiry Date |
13 April 2027
|