AWIQLI Solution for injection Ref.[110293] Active ingredients: Insulin icodec

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Novo Nordisk A/S, Novo Alle 1, DK-2880 Bagsvaerd, Denmark

Product name and form

Awiqli 700 units/mL solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection in pre-filled pen (FlexTouch).

Clear and colourless isotonic solution with a pH of approximately 7.4.

Qualitative and quantitative composition

1 mL solution contains 700 units of insulin icodec* (equivalent to 26.8 mg insulin icodec).

Each pre-filled pen contains 700 units of insulin icodec in 1 mL solution.

Each pre-filled pen contains 1 050 units of insulin icodec in 1.5 mL solution.

Each pre-filled pen contains 2 100 units of insulin icodec in 3 mL solution.

* produced in Saccharomyces cerevisiae by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Insulin icodec

The primary action of insulin, including insulin icodec, is to regulate glucose metabolism. A slow and steady glucose-lowering effect of insulin icodec is driven by albumin binding as well as reduced insulin receptor binding and clearance. The extended half-life of insulin icodec reflects a depot of insulin icodec in the circulation and in the interstitial compartment, from which insulin icodec is slowly and continuously released and binds specifically to the insulin receptor.
List of Excipients

Glycerol
Metacresol
Phenol
Zinc acetate
Sodium chloride
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

1, 1.5 or 3 mL solution in a cartridge (type I glass) with a plunger (halobutyl) and a laminated rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene, polyoxymethylene, polycarbonate and acrylonitrile butadiene styrene. The cap holder for the longer cartridge containing 3 mL (2 100 units solution has a design feature as a clip on the pen injector cap.

The pre-filled pen is designed to be used with disposable needles up to a length of 8 mm.

The pen body is in green while the pen label is in darker green with a yellow box highlighting the strength. The outer packaging is in green with the formulation strength indicated in a yellow-coloured box.

Pack sizes:

Awiqli pre-filled pen containing 700 units of insulin icodec in 1 mL solution.

  • 1 pre-filled pen (without needles).
  • 1 pre-filled pen with 9 disposable NovoFine Plus needles.
  • 1 pre-filled pen with 14 disposable NovoFine Plus needles.

Awiqli pre-filled pen containing 1 050 units of insulin icodec in 1.5 mL solution.

  • 1 pre-filled pen (without needles).
  • 1 pre-filled pen with 13 disposable NovoFine Plus needles.
  • 1 pre-filled pen with 14 disposable NovoFine Plus needles.
  • Multipack containing 2 (2 packs of 1) pre-filled pens with 26 (2 packs of 13) disposable NovoFine Plus needles.
  • Multipack containing 2 (2 packs of 1) pre-filled pens with 28 (2 packs of 14) disposable NovoFine Plus needles.

Awiqli pre-filled pen containing 2 100 units of insulin icodec in 3 mL solution.

  • 1 pre-filled pen (without needles).
  • 2 pre-filled pens (without needles).
  • 1 pre-filled pen with 13 disposable NovoFine Plus needles.
  • 1 pre-filled pen with 14 disposable NovoFine Plus needles.
  • Multipack containing 2 (2 packs of 1) pre-filled pens with 26 (2 packs of 13) disposable NovoFine Plus needles.
  • Multipack containing 2 (2 packs of 1) pre-filled pens with 28 (2 packs of 14) disposable NovoFine Plus needles.

Not all pack sizes may be marketed.

Marketing authorization holder

Novo Nordisk A/S, Novo Alle 1, DK-2880 Bagsvaerd, Denmark

Marketing authorization dates and numbers

Awiqli 700 units/mL solution for injection in pre-filled pen:

EU/1/24/1815/001
EU/1/24/1815/002
EU/1/24/1815/003
EU/1/24/1815/004
EU/1/24/1815/005
EU/1/24/1815/006
EU/1/24/1815/007
EU/1/24/1815/008
EU/1/24/1815/009
EU/1/24/1815/010
EU/1/24/1815/011
EU/1/24/1815/012
EU/1/24/1815/013
EU/1/24/1815/014

Drugs

Drug Countries
AWIQLI Lithuania
 
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