| Product Information |
|
| Registration Number |
DR-XY48930
|
| Generic Name |
Entrectinib nib
|
| Brand Name |
Rozlytrek
|
| Dosage Strength |
200 mg
|
| Dosage Form |
Capsule
|
| Classification |
Prescription (Rx) Drug
|
| Pharmacologic Category |
-
|
| Packaging |
White HDPE Bottle with dessicant and a child-resistant
screw cap (Box of 90 capsules)
|
| Manufacturer |
Mayne Pharma Inc.
|
| Country of Origin |
USA
|
| Trader |
F. Hoffman-La Roche AG
|
| Importer |
Roche (Philippines), Inc.
|
| Distributor |
Roche (Philippines), Inc.
|
| Application Type |
Monitored Release (Re-application)
|
| Issuance Date |
23 November 2023
|
| Expiry Date |
22 November 2028
|