Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain
Ebglyss 250 mg solution for injection in pre-filled syringe.
Ebglyss 250 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear to opalescent, colourless to slightly yellow to slightly brown solution, free of visible particles. |
Ebglyss 250 mg solution for injection in pre-filled syringe: Each single-use pre-filled syringe contains 250 mg of lebrikizumab in 2 mL solution (125 mg/mL).
Ebglyss 250 mg solution for injection in pre-filled pen: Each single-use pre-filled pen contains 250 mg of lebrikizumab in 2 mL solution (125 mg/mL). Lebrikizumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lebrikizumab |
Lebrikizumab is an immunoglobulin (IgG4) monoclonal antibody that binds with high affinity to interleukin (IL)-13 and selectively inhibits IL-13 signalling through the IL-4 receptor alpha (IL-4RĪ±)/ IL-13 receptor alpha 1 (IL-13RĪ±1) heterodimer, thereby inhibiting the downstream effects of IL-13. Inhibition of IL-13 signalling is expected to be of benefit in diseases in which IL-13 is a key contributor to the disease pathogenesis. Lebrikizumab does not prevent the binding of IL-13 to the IL-13 receptor alpha 2 (IL-13RĪ±2 or decoy receptor), which allows the internalisation of IL-13 into the cell. |
| List of Excipients |
|---|
|
Histidine |
2 mL solution in a 2.25 mL Type-1 clear glass pre-filled syringe with small round flange, with a 27 gauge special thin wall x 12.7 mm stacked stainless steel needle, closed with a laminated bromobutyl elastomeric plunger and a rigid needle shield and assembled in a passive safety device.
Pack sizes:
1 pre-filled syringe
2 pre-filled syringes
multipack containing 3 (3 packs of 1) single-dose pre-filled syringes
multipack containing 4 (2 packs of 2) single-dose pre-filled syringes
multipack containing 5 (5 packs of 1) single-dose pre-filled syringes
multipack containing 6 (3 packs of 2) single-dose pre-filled syringes
2 mL solution in a 2.25 mL Type-1 clear glass syringe in a pre-filled pen with extra-small round flange, with a 27 gauge special thin wall x 8 mm stacked stainless steel needle, and closed with a laminated bromobutyl elastomeric plunger and a rigid needle shield.
Pack sizes:
1 pre-filled pen
2 pre-filled pens
multipack containing 3 (3 packs of 1) single-dose pre-filled pens
multipack containing 4 (2 packs of 2) single-dose pre-filled pens
multipack containing 5 (5 packs of 1) single-dose pre-filled pens
multipack containing 6 (3 packs of 2) single-dose pre-filled pens
Not all pack sizes may be marketed.
Almirall, S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain
EU/1/23/1765/001
EU/1/23/1765/002
EU/1/23/1765/003
EU/1/23/1765/004
EU/1/23/1765/005
EU/1/23/1765/006
EU/1/23/1765/007
EU/1/23/1765/008
EU/1/23/1765/009
EU/1/23/1765/010
EU/1/23/1765/011
EU/1/23/1765/012
| Drug | Countries | |
|---|---|---|
| EBGLYSS | Austria, Estonia, Croatia, Ireland, Italy, Lithuania, United Kingdom, United States |
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