Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Enspryng 120 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Colourless to slightly yellow liquid. The solution has a pH of approximately 6.0 and an osmolality of approximately 310 mOsm/kg. |
Each pre-filled syringe (PFS) contains 120 mg of satralizumab in 1 mL.
Satralizumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Satralizumab |
Satralizumab is a recombinant humanised immunoglobuline G2 (IgG2) monoclonal antibody (mAb) that binds to soluble and membrane-bound human IL-6 receptor (IL-6R) and thereby prevents IL-6 downstream signalling through these receptors. |
| List of Excipients |
|---|
|
Histidine |
1 mL solution in a PFS (polymer) with a staked-in, stainless steel needle, fitted with a chlorinated butyl rubber-polypropylene rigid needle shield and sealed with a chlorinated butyl rubber plunger stopper. The PFS is labelled and assembled with an automatic needle guard, plunger rod, and extended finger flanges (EFF).
Pack size of 1 PFS and multipack of 3 (3 packs of 1) PFS. Not all pack sizes may be marketed.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/21/1559/001
EU/1/21/1559/002
| Drug | Countries | |
|---|---|---|
| ENSPRYNG | Canada, Ecuador, Estonia, Finland, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Poland, Romania, Turkey, United States |
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