| Product Information |
DR-XY44831_PI_01.pdf
|
| Registration Number |
DR-XY44831
|
| Generic Name |
Bendamustine Hydrochloride
|
| Brand Name |
Ribomustin
|
| Dosage Strength |
25 mg
|
| Dosage Form |
Lyophilized Powder For Concentrate For Solution For IV Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Alkylating Agent
|
| Packaging |
Type I brown glass vial with grey bromobutyl rubber stopper and blue polypropylene disc aluminum flip-off cap (Box of 1's)
|
| Manufacturer |
Oncotec Pharma Produktion GmbH
|
| Country of Origin |
Germany
|
| Trader |
N/A
|
| Importer |
Johnson and Johnson (Phils.) Inc.
|
| Distributor |
Johnson and Johnson (Phils.) Inc.
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
13 May 2022
|
| Expiry Date |
22 September 2025
|