Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Sanofi-aventis groupe, 54, rue La Boétie, 75008, Paris, France
Dupixent 300 mg solution for injection in pre-filled syringe.
Dupixent 300 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear to slightly opalescent, colourless to pale yellow sterile solution, which is free from visible particulates, with a pH of approximately 5.9. |
Dupilumab 300 mg solution for injection in pre-filled syringe: Each single-use pre-filled syringe contains 300 mg of dupilumab in 2 ml solution (150 mg/ml).
Dupilumab 300 mg solution for injection in pre-filled pen: Each single-use pre-filled pen contains 300 mg of dupilumab in 2 ml solution (150 mg/ml).
Dupilumab is a fully human monoclonal antibody against interleukin (IL)-4 receptor alpha that inhibits IL-4/IL-13 signalling, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dupilumab |
Dupilumab is a recombinant human IgG4 monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling. Dupilumab inhibits IL-4 signaling via the Type I receptor (IL-4Rα/γc), and both IL-4 and IL-13 signaling through the Type II receptor (IL-4Rα/IL-13Rα). IL-4 and IL-13 are major drivers of human type 2 inflammatory disease, such as atopic dermatitis, asthma, and CRSwNP. Blocking the IL-4/IL-13 pathway with dupilumab in patients decreases many of the mediators of type 2 inflammation. |
| List of Excipients |
|---|
|
Arginine hydrochloride |
2 ml solution in a siliconised type-1 clear glass pre-filled syringe with or without needle shield, with a fixed 27 gauge 12.7 mm (1⁄2 inch), thin wall stainless steel staked needle.
Pack size:
2 mL solution in a siliconised type-1 clear glass syringe in a pre-filled pen, with a fixed 27 gauge 12.7 mm (½ inch), thin wall stainless steel staked needle.
The pre-filled pen is available either with a round cap and oval viewing window encircled with an arrow or with a square cap with ridges and an oval viewing window without an arrow.
Pack size:
Not all pack sizes may be marketed.
Sanofi-aventis groupe, 54, rue La Boétie, 75008, Paris, France
EU/1/17/1229/001
EU/1/17/1229/002
EU/1/17/1229/004
EU/1/17/1229/005
EU/1/17/1229/006
EU/1/17/1229/008
EU/1/17/1229/017
EU/1/17/1229/018
EU/1/17/1229/020
EU/1/17/1229/026
EU/1/17/1229/027
EU/1/17/1229/028
Date of first authorisation: 26 September 2017
Date of latest renewal: 02 September 2022
| Drug | Countries | |
|---|---|---|
| DUPIXENT | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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