Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany
Libmyris 40 mg solution for injection in pre-filled syringe.
Libmyris 40 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear and colourless solution for injection. |
Libmyris 40 mg solution for injection in pre-filled syringe: One 0.4 ml single dose pre-filled syringe contains 40 mg adalimumab.
Libmyris 40 mg solution for injection in pre-filled pen: One 0.4 ml single dose pre-filled pen contains 40 mg adalimumab.
Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Adalimumab |
Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM). |
| List of Excipients |
|---|
|
Sodium chloride |
0.4 ml preservative-free solution for injection in a pre-filled type I glass syringe with a fixed 29-gauge needle, extended finger flanges and needle guard, and a plunger stopper (bromobutyl rubber, latexfree).
Pack sizes: 1, 2 or 6 pre-filled syringe(s) packed in a PVC/PE blister, with 1, 2 or 6 alcohol pad(s).
0.4 ml preservative-free solution for injection in pre-filled needle-based injection system (autoinjector) containing a pre-filled type I glass syringe with a fixed 29-gauge needle and a plunger stopper (bromobutyl rubber, latex-free). The pen is a single use, disposable, handheld, mechanical injection device.
Pack sizes: 1, 2 or 6 pre-filled pens packed in a PVC/PE blister, with 1, 2 or 6 alcohol pad(s).
STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany
Libmyris 40 mg solution for injection in pre-filled syringe:
EU/1/21/1590/001
EU/1/21/1590/002
EU/1/21/1590/003
Libmyris 40 mg solution for injection in pre-filled pen:
EU/1/21/1590/004
EU/1/21/1590/005
EU/1/21/1590/006
| Drug | Countries | |
|---|---|---|
| LIBMYRIS | Austria, Estonia, France, Croatia, Ireland, Lithuania, Poland |
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