| Product Information |
DR-XY44999_PI_01.pdf
|
| Registration Number |
DR-XY44999
|
| Generic Name |
Dabrafenib (As Mesilate)
|
| Brand Name |
Tafinlar
|
| Dosage Strength |
50 mg
|
| Dosage Form |
Capsule
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Opaque White HDPE Plastic Bottle with Polypropylene Child resistant closure x 28's and 120's (Box of 1 bottle x 28's; Box of 1 bottle x 120's)
|
| Manufacturer |
Glaxo Operations UK Limited Trading as Glaxo Wellcome Operations
|
| Country of Origin |
United Kingdom
|
| Trader |
N/A
|
| Importer |
Novartis Healthcare Philippines, Inc.
|
| Distributor |
Novartis Healthcare Philippines, Inc.
|
| Application Type |
Initial (from Monitored release)
|
| Issuance Date |
02 December 2022
|
| Expiry Date |
02 February 2026
|