| Product Information |
DR-XY48337_PI_01.pdf
|
| Registration Number |
DR-XY48337
|
| Generic Name |
Erdafitinib
|
| Brand Name |
Balversa
|
| Dosage Strength |
4 mg
|
| Dosage Form |
Film-Coated Tablet
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic Agent [Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor]
|
| Packaging |
PVC-PCTFE Foil Blister with an Aluminum Push
through Foil in a Wallet Pack x 14's and 28's (Box of 14's, 28's and 56's)
|
| Manufacturer |
Janssen Cilag S.p.A
|
| Country of Origin |
Italy
|
| Trader |
N/A
|
| Importer |
Johnson & Johnson (Philippines), Inc.
|
| Distributor |
Johnson & Johnson (Philippines), Inc.
|
| Application Type |
Monitored Release
|
| Issuance Date |
02 September 2022
|
| Expiry Date |
02 September 2027
|