| Product Information |
|
| Registration Number |
DR-XY45596
|
| Generic Name |
Rupatadine (as fumarate)
|
| Brand Name |
Rupafin
|
| Dosage Strength |
1 mg/mL
|
| Dosage Form |
Oral Solution
|
| Classification |
Prescription (Rx) Drug
|
| Pharmacologic Category |
-
|
| Packaging |
120 mL (net content) amber PET bottle with yellow child- resistant HDPE closure with perforated LDPE stopper + 5 mL-capacity oral graduated syringe (Box of 1's)
|
| Manufacturer |
Italfarmaco, S.A.
|
| Country of Origin |
Spain
|
| Trader |
Hyphens Pharma Pte. Ltd
|
| Importer |
Hyphens Pharma Philippines, Inc.
|
| Distributor |
Hyphens Pharma Philippines, Inc.
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
12 September 2023
|
| Expiry Date |
07 September 2026
|