NUCALA Powder for solution for injection Ref.[8924] Active ingredients: Mepolizumab

Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Nucala 100 mg powder for solution for injection.

Pharmaceutical Form
Powder for solution for injection. Lyophilised white powder.

Qualitative and quantitative composition

Each vial contains 100 mg mepolizumab. After reconstitution, each ml of solution contains 100 mg mepolizumab.

Mepolizumab is a humanised monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Mepolizumab	Mepolizumab is a humanised monoclonal antibody (IgG1, kappa), which targets human interleukin-5 (IL-5) with high affinity and specificity. IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation and survival of eosinophils. Mepolizumab is indicated as an add-on treatment for severe refractory eosinophilic asthma.

List of Excipients
Sucrose Sodium phosphate dibasic heptahydrate Polysorbate 80

Pack sizes and marketing

Clear, colourless 10 mL type I glass vial, with bromobutyl rubber stopper and a grey aluminium overseal with a plastic flip-cap containing 100 mg powder for solution for injection.

Pack sizes:

1 vial
Multipack comprising 3 (3 packs of 1) vials

Not all pack-sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

EU/1/15/1043/001
EU/1/15/1043/002

Date of first authorisation: 02 December 2015
Date of latest renewal: 10 August 2020

Drugs

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

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