ZEGALOGUE Solution for injection Ref.[115117] Active ingredients: Dasiglucagon

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Novo Nordisk A/S, Novo Alle 1, DK-2880 Bagsvaerd, Denmark

Product name and form

Zegalogue 0.6 mg solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection (injection).

Clear, colorless solution, pH 6.5 and osmolality of 330-490 mOsm/kg.

Qualitative and quantitative composition

Each pre-filled syringe contains 0.6 mg dasiglucagon (as hydrochloride) in 0.6 mL.

For the full list of excipients, see section 6.1.

Active Ingredient

Dasiglucagon is a glucagon receptor agonist analogue, which increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for dasiglucagon to produce an antihypoglycaemic effect.

List of Excipients

Trometamol
Sodium chloride
Water for injections
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

Zegalogue 0.6 mg solution for injection in pre-filled syringe:

Glass (type I) pre-filled syringe with staked stainless steel needle, rigid needle shield/grey needle cover, rubber plunger (bromobutyl) and red plunger rod (polypropylene). Each pre-filled syringe contains 0.6 mL of solution for injection and is individually packaged in a protective case.

Pack sizes of 1 or 2 single-dose pre-filled syringes.

Not all pack sizes or presentations may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/24/1829/003
EU/1/24/1829/004

Date of first authorisation: 24 July 2024

Drugs

Drug Countries
ZEGALOGUE Estonia, Lithuania

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