HUMIRA 40mg/0.8ml Solution for injection Ref.[7461] Active ingredients: Adalimumab

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Product name and form

Humira 40 mg/0.8 ml solution for injection.

Pharmaceutical Form

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.

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

Mannitol
Citric acid monohydrate
Sodium citrate
Sodium dihydrogen phosphate dihydrate
Disodium phosphate dihydrate
Sodium chloride
Polysorbate 80
Sodium hydroxide
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.

Marketing authorization holder

AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Marketing authorization dates and numbers

EU/1/03/256/001

Date of first authorisation: 8 September 2003
Date of latest renewal: 8 September 2008

Drugs

Drug Countries
HUMIRA Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa
 
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