HUMIRA 40mg/0.8ml Solution for injection in pre-filled syringe / pen Ref.[6075] 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 solution for injection in pre-filled syringe.

Humira 40 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection. (injection)

Clear, colourless solution.

Qualitative and quantitative composition

Humira 40 mg solution for injection in pre-filled syringe: Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.

Humira 40 mg solution for injection in pre-filled pen: Each 0.8 ml single dose pre-filled pen 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

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 pre-filled syringe: Humira 40 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:

  • 1 pre-filled syringe (0.8 ml sterile solution) with 1 alcohol pad in a blister.
  • 2 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
  • 4 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
  • 6 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.

Humira 40 mg solution for injection in pre-filled syringe with needle guard: Humira 40 mg solution for injection in single-use pre-filled syringe (type I glass) with needle guard for hospital and caregiver use. The syringe is made from type 1 glass with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).

Packs of: 1 pre-filled syringe with needle guard (0.8 ml sterile solution) in a blister, and 1 alcohol pad.

Humira 40 mg solution for injection in pre-filled pen: Humira 40 mg solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe. The syringe inside the pen is made from type 1 glass with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).

Packs of:

  • 1 pre-filled pen (0.8 ml sterile solution), with 2 alcohol pads in a blister.
  • 2 pre-filled pens (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
  • 4 pre-filled pens (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
  • 6 pre-filled pens (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.

Not all presentations or pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

Humira 40 mg solution for injection in pre-filled syringe:

EU/1/03/256/002
EU/1/03/256/003
EU/1/03/256/004
EU/1/03/256/005

Humira 40 mg solution for injection in pre-filled syringe with needle guard:

EU/1/03/256/006

Humira 40 mg solution for injection in pre-filled pen:

EU/1/03/256/007
EU/1/03/256/008
EU/1/03/256/009
EU/1/03/256/010

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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