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

Source: European Medicines Agency (EU)  Revision Year: 2019  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.

Pharmaceutical Form

Solution for injection (injection).

Clear, colourless solution.

Qualitative and quantitative composition

Trulicity 0.75 mg solution for injection:

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

Trulicity 1.5 mg solution for injection:

Each pre-filled pen contains 1.5 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 Description
Dulaglutide

Dulaglutide is a long-acting glucagon-like peptide 1 (GLP-1) receptor agonist. In contrast to native GLP-1, dulaglutide is resistant to degradation by DPP-4, and has a large size that slows absorption and reduces renal clearance. Dulaglutide improves glycaemic control through the sustained effects of lowering fasting, pre-meal and postprandial glucose concentrations in patients with type 2 diabetes.

List of Excipients

Sodium citrate
Citric acid, anhydrous
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

Date of first authorisation: 21 November 2014

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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