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
|