Approvals/TGA/SEMGLEE insulin glargine (rDNA) 100 IU/mL, 3 mL solution for injection injector pen

Approved

STANDARD

SEMGLEE insulin glargine (rDNA) 100 IU/mL, 3 mL solution for injection injector pen

Maxx Pharma Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: d2e62ea81cfb8e73
Product Name: SEMGLEE insulin glargine (rDNA) 100 IU/mL, 3 mL solution for injection injector pen
Artg Id: 286207
Artg Name: SEMGLEE insulin glargine (rDNA) 100 IU/mL, 3 mL solution for injection injector pen
Sponsor: Maxx Pharma Pty Ltd
Company Detail Path: /organization/maxx-pharma-pty-ltd
Artg Date: 2018-03-28
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2025-CMI-01331-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2025-PI-01332-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

d2e62ea81cfb8e73

Type

Standard