Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland
Nucala 100 mg powder for solution for injection.
| Pharmaceutical Form |
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Powder for solution for injection. Lyophilised white powder. |
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 |
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Sucrose |
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:
Not all pack-sizes may be marketed.
GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland
EU/1/15/1043/001
EU/1/15/1043/002
Date of first authorisation: 02 December 2015
| 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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