| Product Information |
|
| Registration Number |
BRP-056
|
| Generic Name |
Insulin Glargine
|
| Brand Name |
Lantus XR
|
| Dosage Strength |
300 Units (equivalent to 10.91 mg)/mL
|
| Dosage Form |
Solution for Injection (SC)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Insulins and Analogues
|
| Packaging |
Type I colorless glass cartridge with bromobutyl rubber plunger stopper and aluminum flanged cap with punch laminated sealing disk assembled in a pre-filled pen x 1.5 mL (Box of 1's, 3's and 5's).
|
| Manufacturer |
Sanofi-Aventis Deutschland GmbH
|
| Country of Origin |
Germany
|
| Trader |
|
| Importer |
Sanofi-Aventis Philippines, Inc.
|
| Distributor |
Sanofi-Aventis Philippines, Inc.
|
| Application Type |
Initial Variation]
|
| Issuance Date |
19 April 2024
|
| Expiry Date |
19 April 2029
|