| Product Information |
DR-XY43795_PI_01.pdf
|
| Registration Number |
DR-XY43795 (For DOH National Tuberculosis Control Program Use Only)
|
| Generic Name |
Bedaquiline (as fumarate)
|
| Brand Name |
Sirturo
|
| Dosage Strength |
100 mg
|
| Dosage Form |
Tablet
|
| Classification |
Prescription Drug (Rx)
|
| Packaging |
White HDPE plastic bottle x 188's (Box of 1's)
|
| Pharmacologic Category |
-
|
| Manufacturer |
Recipharm Pharmaservices Private Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Johnson & Johnson (Phlippines), Inc.
|
| Distributor |
Johnson & Johnson (Phlippines), Inc.
|
| Application Type |
Initial (from Monitored Release status) (Correction)
|
| Issuance Date |
10 August 2023
|
| Expiry Date |
13 October 2024
|