| Product Information |
|
| Registration Number |
DRP-12083
|
| Generic Name |
Palonosetron (as hydrochloride)
|
| Brand Name |
Palnos
|
| Dosage Strength |
50 mcg/mL (250 mcg 15 mL)
|
| Dosage Form |
Solution for Intravenous
Injection
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Anti-emetic/ Anti-nauseant
(Serotonin [5HT3] Antagonist)
|
| Packaging |
5 mL USP Type I clear glass vial with grey bromobutyl
rubber stopper and aluminum seal and blue PP flip off cap (Box of 1's)
|
| Manufacturer |
PT. Ferron Par Pharmaceuticals
|
| Country of Origin |
Indonesia
|
| Trader |
|
| Importer |
Glorious Dexa Mandaya, Inc.
|
| Distributor |
Glorious Dexa Mandaya, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
10 June 2022
|
| Expiry Date |
10 June 2027
|