Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
RoActemra 162 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). A colourless to slightly yellowish solution. |
Each pre-filled syringe contains 162 mg of tocilizumab in 0.9 mL.
Tocilizumab is a recombinant humanized, anti-human monoclonal antibody of the immunoglobulin G1 (IgG1) sub-class directed against soluble and membrane-bound interleukin 6 receptors.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tocilizumab |
Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R). IL-6 is involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, induction of hepatic acute phase protein synthesis and stimulation of haemopoiesis. IL-6 has been implicated in the pathogenesis of diseases including inflammatory diseases, osteoporosis and neoplasia. |
| List of Excipients |
|---|
|
L-Histidine |
0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle. The syringe is closed by a rigid needle shield (elastomer seal with a polypropylene shell) and a plunger stopper (butyl rubber with a fluororesin coating).
Pack sizes of 4 pre-filled syringes and multipacks containing 12 (3 packs of 4) pre-filled syringes. Not all pack sizes may be marketed.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
EU/1/08/492/007
EU/1/08/492/008
Date of first authorisation: 16 January 2009
Date of last renewal: 25 September 2013
| Drug | Countries | |
|---|---|---|
| RoACTEMRA | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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