| Product Information |
|
| Registration Number |
DR-XY48477
|
| Generic Name |
Leuprorelin Acetate
|
| Brand Name |
Luprolex
|
| Dosage Strength |
11.25mg/mL
|
| Dosage Form |
Powder for Prolonged-Release
Suspension for Injection (IM/SC)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Dual Chamber Pre-filled Syringe with Safety Device (Box of 1's)
|
| Manufacturer |
Takeda Pharmaceutical Company Limited (Hikari
Plant)
|
| Country of Origin |
United Kingdom
|
| Trader |
N/A
|
| Importer |
Takeda Healthcare Philippines Inc.
|
| Distributor |
Takeda Healthcare Philippines Inc.
|
| Application Type |
Initial
|
| Issuance Date |
24 November 2022
|
| Expiry Date |
24 November 2027
|