| Product Information |
DR-XY45879_PI_01.pdf
|
| Registration Number |
DR-XY45879
|
| Generic Name |
Osimertinib (as mesylate)
|
| Brand Name |
Tagrisso
|
| Dosage Strength |
40 mg
|
| Dosage Form |
Film-Coated Tablet
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Protein Kinase Inhibitors
|
| Packaging |
Alu/Alu Blister Pack x 10's (Box of 30's)
|
| Manufacturer |
AstraZeneca AB
|
| Country of Origin |
Sweden
|
| Trader |
N/A
|
| Importer |
AstraZeneca Pharmaceuticals (Phils.), Inc.
|
| Distributor |
AstraZeneca Pharmaceuticals (Phils.), Inc.
|
| Application Type |
Initial (from Monitored Release) [Variation]
|
| Issuance Date |
29 August 2023
|
| Expiry Date |
29 August 2028
|