LIBMYRIS 80 mg Solution for injection Ref.[28339] Active ingredients: Adalimumab

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany

Product name and form

Libmyris 80 mg solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection.

Clear and colourless solution for injection.

Qualitative and quantitative composition

One 0.8 ml single dose pre-filled syringe contains 80 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
Sucrose
Polysorbate 80
Water for injections
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

0.8 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 pre-filled syringe packed in a PVC/PE blister, with 1 alcohol pad.

Marketing authorization holder

STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany

Marketing authorization dates and numbers

EU/1/21/1590/007

Drugs

Drug Countries
LIBMYRIS Austria, Estonia, France, Croatia, Ireland, Lithuania, Poland

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