Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Simponi 50 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). The solution is clear to slightly opalescent, colourless to light yellow. |
One 0.5 mL pre-filled syringe contains 50 mg of golimumab*.
* Human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology.
Excipients with known effect:
Each pre-filled syringe contains 20.5 mg sorbitol (E420) per 50 mg dose.
Each pre-filled syringe contains 0.075 mg of polysorbate 80 (E433) per 50 mg dose.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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Golimumab is a human monoclonal antibody that forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human TNF-α, which prevents the binding of TNF-α to its receptors. |
| List of Excipients |
|---|
|
Sorbitol (E420) |
Simponi 50 mg solution for injection in pre-filled syringe:
0.5 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex). Simponi is available in packs containing 1 pre-filled syringe and multipacks containing 3 (3 packs of 1) pre-filled syringes.
Not all pack sizes may be marketed.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/09/546/003 1 pre-filled syringe
EU/1/09/546/004 3 pre-filled syringes
Date of first authorisation: 1 October 2009
Date of latest renewal: 19 June 2014
| Drug | Countries | |
|---|---|---|
| SIMPONI | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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