RoACTEMRA Concentrate for solution for infusion Ref.[8353] Active ingredients: Tocilizumab

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Product name and form

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.

Qualitative and quantitative composition

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
Polysorbate 80
Disodium phosphate dodecahydrate
Sodium dihydrogen phosphate dihydrate
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Marketing authorization dates and numbers

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

Drugs

Drug Countries
RoACTEMRA Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom

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