| Product Information |
DR-XY47770_PI_01.pdf
|
| Registration Number |
DR-XY47770
|
| Generic Name |
Macitentan
|
| Brand Name |
Opsumit
|
| Dosage Strength |
10 mg
|
| Dosage Form |
Film-Coated Tablet
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antihypertensive
|
| Packaging |
PVC/PE/PVDC-Aluminum Foil Blister Pack x 15's
(Box of 30's)
|
| Manufacturer |
Excella GmbH & Co. KG
|
| Country of Origin |
Germany
|
| Trader |
Actelion Pharmaceuticals Ltd.
|
| Importer |
Johnson & Johnson (Phils.), Inc.
|
| Distributor |
N/A
|
| Application Type |
Monitored Release
|
| Issuance Date |
03 March 2022
|
| Expiry Date |
03 March 2027
|