| Product Information |
DR-XY46520_PI_01.pdf
|
| Registration Number |
DR-XY46520
|
| Generic Name |
Sofosbuvir + Velpatasvir
|
| Brand Name |
Epclusa
|
| Dosage Strength |
400 mg/100 mg
|
| Dosage Form |
Film-Coated Tablet
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antiretroviral
|
| Packaging |
White high-density polyethylene (HDPE) bottle and a polypropylene (PP) continuous-thread child-resistant cap lined with an inductin activated aluminum foil liner (Box of 28's)
|
| Manufacturer |
Patheon Inc.
|
| Country of Origin |
Canada
|
| Trader |
|
| Importer |
A. Menarini Philippines, Inc.
|
| Distributor |
A. Menarini Philippines, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
19 February 2019
|
| Expiry Date |
19 February 2025
|