| Product Information |
|
| Registration Number |
BR-1057
|
| Generic Name |
Insulin detemir
|
| Brand Name |
Levemir FlexPen
|
| Dosage Strength |
100 U/mL
|
| Dosage Form |
Solution for Injection (SC)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
3 mL solution in cartridge (Type I glass) with a plunger
(bromobutyl) and a stopper (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene (Box of 5's)
|
| Pharmacologic Category |
Antidiabetics
|
| Manufacturer |
Novo Nordisk Producao Farmaceutica do Brasil Ltda.
|
| Country of Origin |
Brazil
|
| Trader |
|
| Importer |
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
| Distributor |
Novo Nordisk Pharmaceuticals (Philippines), Inc.
|
| Application Type |
Renewal
|
| Issuance Date |
31 March 2025
|
| Expiry Date |
18 March 2031
|