TRULICITY Solution for injection Ref.[6812] Active ingredients: Dulaglutide

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Product name and form

Trulicity 0.75 mg solution for injection in pre-filled pen.

Trulicity 1.5 mg solution for injection in pre-filled pen.

Trulicity 3 mg solution for injection in pre-filled pen.

Trulicity 4.5 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

Clear, colourless solution.

Qualitative and quantitative composition

Trulicity 0.75 mg solution for injection in pre-filled pen: Each pre-filled pen contains 0.75 mg of dulaglutide* in 0.5 ml solution.

Trulicity 1.5 mg solution for injection in pre-filled pen: Each pre-filled pen contains 1.5 mg of dulaglutide* in 0.5 ml solution.

Trulicity 3 mg solution for injection in pre-filled pen: Each pre-filled pen contains 3 mg of dulaglutide* in 0.5 ml solution.

Trulicity 4.5 mg solution for injection in pre-filled pen: Each pre-filled pen contains 4.5 mg of dulaglutide* in 0.5 ml solution.

* produced in CHO cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient

Dulaglutide is a long-acting glucagon-like peptide 1 (GLP-1) receptor agonist. Dulaglutide exhibits several antihyperglycaemic actions of GLP-1. In the presence of elevated glucose concentrations, dulaglutide increases intracellular cyclic AMP (cAMP) in pancreatic beta cells leading to insulin release. Dulaglutide suppresses glucagon secretion which is known to be inappropriately elevated in patients with type 2 diabetes.

List of Excipients

Sodium citrate
Citric acid
Mannitol
Polysorbate 80
Water for injections

Pack sizes and marketing

Glass syringe (type I) encased in a disposable pen.

Each pre-filled pen contains 0.5 ml of solution.

Packs of 2 and 4 pre-filled pens and multipack of 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed.

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Marketing authorization dates and numbers

EU/1/14/956/001
EU/1/14/956/002
EU/1/14/956/003
EU/1/14/956/006
EU/1/14/956/007
EU/1/14/956/008
EU/1/14/956/011
EU/1/14/956/012
EU/1/14/956/013
EU/1/14/956/014
EU/1/14/956/015
EU/1/14/956/016

Date of first authorisation: 21 November 2014
Date of latest renewal: 23 August 2019

Drugs

Drug Countries
TRULICITY Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

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