| Product Information |
|
| Registration Number |
DRP-11545
|
| Generic Name |
Midazolam (as hydrochloride)
|
| Brand Name |
None
|
| Dosage Strength |
5 mg/mL
|
| Dosage Form |
Solution for Injection/Infusion (IM/IV/Rectal)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Hypnotic/Sedative (Benzodiazepine derivative)
|
| Packaging |
Type I clear colorless glass ampoule
(Box of 10's x 1 mL; Box of 10's x 3 mL)
|
| Manufacturer |
Siegfried Hameln GmbH
|
| Country of Origin |
Germany
|
| Trader |
N/A
|
| Importer |
Enlife Global Inc.
|
| Distributor |
Enlife Global Inc.
|
| Application Type |
Initial
|
| Issuance Date |
05 May 2022
|
| Expiry Date |
05 May 2027
|