| Product Information |
|
| Registration Number |
DR-XY45509
|
| Generic Name |
Irbesartan + Amlodipine (as besilate)
|
| Brand Name |
Aprovasc
|
| Dosage Strength |
150/5 mg
|
| Dosage Form |
Film-Coated Tablet
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antihypertensive (Angiotensin II Receptor Blocker/
Calcium Channel Blocker combination)
|
| Packaging |
Alu/White Opaque PVC/PE/PVDC Blister pack x 7's
(Box of 28's)
|
| Manufacturer |
Sanofi Aventis De México S.A. De C.V.
|
| Country of Origin |
Mexico
|
| Trader |
N/A
|
| Importer |
Sanofi-Aventis Philippines, Inc.
|
| Distributor |
N/A
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
08 February 2023
|
| Expiry Date |
14 July 2026
|