Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
RoActemra 20 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to opalescent, colourless to pale yellow solution. |
Each mL concentrate contains 20 mg tocilizumab*.
Each vial contains 80 mg of tocilizumab* in 4 mL (20 mg/mL).
Each vial contains 200 mg of tocilizumab* in 10 mL (20 mg/mL).
Each vial contains 400 mg of tocilizumab* in 20 mL (20 mg/mL).
==*==humanised IgG1 monoclonal antibody against the human interleukin-6 (IL-6) receptor produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Excipients with known effects:
Each 80 mg vial contains 0.10 mmol (2.21 mg) sodium.
Each 200 mg vial contains 0.20 mmol (4.43 mg) sodium.
Each 400 mg vial contains 0.39 mmol (8.85 mg) sodium.
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 |
|---|
|
Sucrose |
RoActemra is supplied in a vial (type I glass) with a stopper (butyl rubber) containing 4 mL, 10 mL or 20 mL concentrate. Pack sizes of 1 and 4 vials.
Not all pack sizes may be marketed.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
EU/1/08/492/001
EU/1/08/492/002
EU/1/08/492/003
EU/1/08/492/004
EU/1/08/492/005
EU/1/08/492/006
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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