Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Simponi 45 mg/0.45 mL solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
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Solution for injection (injection) in pre-filled pen (VarioJect). The solution is clear to slightly opalescent, colourless to light yellow. |
One pre-filled pen contains 45 mg golimumab* in 0.45 mL. 1 mL solution contains 100 mg golimumab.
Each pre-filled pen can deliver 0.1 mL to 0.45 mL (corresponding to 10 mg to 45 mg golimumab) in increments of 0.05 mL.
* Human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology.
Excipients with known effect:
Each pre-filled pen contains 18.5 mg sorbitol (E420) per 45 mg dose.
Each pre-filled pen contains 0.068 mg of polysorbate 80 (E433) per 45 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 45 mg/0.45 mL solution for injection:
0.45 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex) in a pre-filled pen. Each pre-filled pen can deliver 0.1 mL to 0.45 mL in increments of 0.05 mL.
Pack size of 1 pre-filled pen.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/09/546/009 1 pre-filled pen
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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