Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Cosentyx 150 mg solution for injection in pre-filled syringe.
Cosentyx 300 mg solution for injection in pre-filled syringe.
Cosentyx 150 mg solution for injection in pre-filled pen.
Cosentyx 300 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
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Solution for injection (injection). The solution is clear and colourless to slightly yellow. |
Cosentyx 150 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 150 mg secukinumab in 1 ml.
Cosentyx 300 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 300 mg secukinumab in 2 ml.
Cosentyx 150 mg solution for injection in pre-filled pen: Each pre-filled pen contains 150 mg secukinumab in 1 ml.
Cosentyx 300 mg solution for injection in pre-filled pen: Each pre-filled pen contains 300 mg secukinumab in 2 ml.
Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Secukinumab |
Secukinumab is a fully human IgG1/κ monoclonal antibody that selectively binds to and neutralises the proinflammatory cytokine interleukin-17A (IL-17A). Secukinumab works by targeting IL-17A and inhibiting its interaction with the IL-17 receptor, which is expressed on various cell types including keratinocytes. As a result, secukinumab inhibits the release of proinflammatory cytokines, chemokines and mediators of tissue damage and reduces IL-17A-mediated contributions to autoimmune and inflammatory diseases. |
| List of Excipients |
|---|
|
Trehalose dihydrate |
Cosentyx 150 mg solution for injection in pre-filled syringe:
Cosentyx 150 mg solution for injection in pre-filled syringe is supplied in a pre-filled 1 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of styrene butadiene rubber assembled in an automatic needle guard of polycarbonate.
Cosentyx 150 mg solution for injection in pre-filled syringe is available in unit packs containing 1 or 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
Cosentyx 300 mg solution for injection in pre-filled syringe:
Cosentyx 300 mg solution for injection in pre-filled syringe is supplied in a pre-filled 2.25 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of synthetic polyisoprene rubber assembled in an automatic needle guard of polycarbonate.
Cosentyx 300 mg solution for injection in pre-filled syringe is available in unit packs containing 1 pre-filled syringe and in multipacks containing 3 (3 packs of 1) pre-filled syringes.
Cosentyx 150 mg solution for injection in pre-filled pen:
Cosentyx 150 mg solution for injection in pre-filled pen is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label. The pre-filled syringe inside the pen is a 1 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of styrene butadiene rubber.
Cosentyx 150 mg solution for injection in pre-filled pen is available in unit packs containing 1 or 2 pre-filled pens and in multipacks containing 6 (3 packs of 2) pre-filled pens.
Cosentyx 300 mg solution for injection in pre-filled pen:
Cosentyx 300 mg solution for injection in pre-filled pen is supplied in a single-use pre-filled syringe assembled into a squared-shaped pen with transparent window and label. The pre-filled syringe inside the pen is a 2.25 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of synthetic polyisoprene rubber.
Cosentyx 300 mg solution for injection in pre-filled pen is available in unit packs containing 1 pre-filled pen and in multipacks containing 3 (3 packs of 1) pre-filled pens.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Cosentyx 150 mg solution for injection in pre-filled syringe:
EU/1/14/980/002
EU/1/14/980/003
EU/1/14/980/006
Cosentyx 300 mg solution for injection in pre-filled syringe:
EU/1/14/980/008-009
Cosentyx150 mg solution for injection in pre-filled pen:
EU/1/14/980/004
EU/1/14/980/005
EU/1/14/980/007
Cosentyx 300 mg solution for injection in pre-filled pen:
EU/1/14/980/010-011
Date of first authorisation: 15 January 2015
Date of latest renewal: 03 September 2019
| Drug | Countries | |
|---|---|---|
| COSENTYX | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States, South Africa |
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