Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
Simponi 50 mg solution for injection in pre-filled pen.
Simponi 50 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection in pre-filled pen (injection), SmartJect. Solution for injection in pre-filled syringe (injection). The solution is clear to slightly opalescent, colourless to light yellow. |
Simponi 50 mg solution for injection in pre-filled pen: One 0.5 mL pre-filled pen contains 50 mg of golimumab*.
Simponi 50 mg solution for injection in pre-filled syringe: One 0.5 mL pre-filled syringe contains 50 mg of golimumab*.
* Human IgG1Îș monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology.
Excipient with known effect:
Each pre-filled pen contains 20.5 mg sorbitol per 50 mg dose.
Each pre-filled syringe contains 20.5 mg sorbitol per 50 mg dose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Golimumab |
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 pen: 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) in a pre-filled pen. Simponi is available in packs containing 1 pre-filled pen and multipacks containing 3 (3 packs of 1) pre-filled pens.
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 Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
1 pre-filled pen: EU/1/09/546/001
3 pre-filled pens: EU/1/09/546/002
1 pre-filled syringe: EU/1/09/546/003
3 pre-filled syringes: EU/1/09/546/004
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, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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