| Product Information |
|
| Registration Number |
DR-XY 48040
|
| Generic Name |
Dexmedetomide (as Hydrochloride)
|
| Brand Name |
Icunes
|
| Dosage Strength |
100 mcg/mL
|
| Dosage Form |
Concentrate for Solution for Intravenous InfusionSolution for Injection
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
2 mL (net content) Type I clear and colorless glass vial
with red bromobutyl rubber stopper and aluminum seal with white polypropylene flip-off cap (Box of 1’s)
|
| Pharmacologic Category |
Hypnotic/Sedative
|
| Manufacturer |
PT. Novell Pharmaceutical Laboratories
|
| Country of Origin |
Indonesia
|
| Trader |
N/A
|
| Importer |
Prosweal Healthcare, Inc.
|
| Distributor |
Prosweal Healthcare, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
25 May 2022
|
| Expiry Date |
25 May 2027
|