HUMIRA 20mg Solution for injection in pre-filled syringe Ref.[7460] 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 20 mg solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection. (injection)

Clear, colourless solution.

Qualitative and quantitative composition

Each 0.2 ml single dose pre-filled syringe contains 20 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
Polysorbate 80
Water for injections

Pack sizes and marketing

Humira 20 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).

Packs of: 2 pre-filled syringes (0.2 ml sterile solution), each with 1 alcohol pad, in a blister.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/03/256/022

Date of first authorisation: 08 September 2003
Date of latest renewal: 08 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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