HUMIRA 40mg/0.8ml Solution for injection (2018)
Active ingredients: Adalimumab
Product Name and Form
Humira 40 mg/0.8 ml solution for injection.
Solution for injection. (injection)
Clear, colourless solution.
Qualitative and Quantitative Composition
Each 0.8 ml single dose vial contains 40 mg of adalimumab.
Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
For the full list of excipients, see section 6.1.
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).
Citric acid monohydrate
Sodium dihydrogen phosphate dihydrate
Disodium phosphate dihydrate
Water for injections
Pack sizes and Marketing
Humira 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals.
1 Pack of 2 boxes each containing: 1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe, 1 needle, 1 vial adapter and 2 alcohol pads.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Date of first authorisation: 8 September 2003
Date of latest renewal: 8 September 2008