LIBMYRIS 40 mg Solution for injection Ref.[28338] Active ingredients: Adalimumab

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany

Product name and form

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.

Qualitative and quantitative composition

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
Sucrose
Polysorbate 80
Water for injections
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

Libmyris 40 mg solution for injection in pre-filled syringe

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).

Libmyris 40 mg solution for injection in pre-filled pen

0.4 ml 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). 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).

Marketing authorization holder

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

Marketing authorization dates and numbers

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

Date of first authorisation: 12 November 2021

Drugs

Drug Countries
LIBMYRIS Austria, Estonia, France, Croatia, Ireland, Lithuania, Poland
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈