| Product Information |
DR-XY45059_PI_01.pdf
|
| Registration Number |
DR-XY45059
|
| Generic Name |
Ceritinib
|
| Brand Name |
Zykadia
|
| Dosage Strength |
150 mg
|
| Dosage Form |
Capsule
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Anaplastic Lymphoma Kinase (ALK) inhibitor
|
| Packaging |
Alu/PCTFE/PVC Blister Pack x 10's x 50's in monocarton. One (1) box contains 3 monocartons x 50 capsules
|
| Manufacturer |
Novartis Pharma Stein
|
| Country of Origin |
Switzerland
|
| Trader |
N/A
|
| Importer |
Novartis Healthcare Philippines, Inc.
|
| Distributor |
N/A
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
20 May 2022
|
| Expiry Date |
11 February 2026
|