| Product Information |
DR-XY45565_PI_01.pdf
|
| Registration Number |
DR-XY45565
|
| Generic Name |
Macitentan
|
| Brand Name |
Opsumit
|
| Dosage Strength |
10 mg
|
| Dosage Form |
Film-Coated Tablet
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
PVC/PE/PVDC/Aluminum Blister Pack x 15's
(Box of 30's)
|
| Manufacturer |
Patheon Italia S.P.A
|
| Country of Origin |
Italy
|
| Trader |
Actelion Pharmaceuticals Ltd.
|
| Importer |
Johnson & Johnson (Phils.) Inc.
|
| Distributor |
Zuellig Pharma Corporation
|
| Application Type |
Initial from Monitored Release]
|
| Issuance Date |
16 February 2023
|
| Expiry Date |
18 August 2026
|