Product Information |
DR-XY44830_PI_01.pdf
|
Registration Number |
DR-XY44830
|
Generic Name |
Bendamustine Hydrochloride
|
Brand Name |
Ribomustin
|
Dosage Strength |
100 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
|