Human Drugs View

Product Information BR-999_PI_01.pdf
Registration Number BR-999
Generic Name Insulin Degludec
Brand Name Tresiba Flextouch
Dosage Strength 100 Units/mL
Dosage Form Solution For Injection (SC)
Classification Prescription Drug (Rx)
Pharmacologic Category -
Packaging Cartridge (Type I Glass) with a Plunger (Halobutyl) and a Stopper (Halobutyl/Polyisoprene) contained in a Pre-filled Multidose Disposable Pen made of Polypropylene
Manufacturer Novo Nordisk A/S
Country of Origin Denmark
Trader
Importer Novo Nordisk Pharmaceuticals (Phils.) Inc.
Distributor Novo Nordisk Pharmaceuticals (Phils.) Inc.
Application Type Initial
Issuance Date 12 May 2021
Expiry Date 16 December 2024