Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany
Humira 40 mg solution for injection in pre-filled syringe.
Humira 40 mg solution for injection in pre-filled pen.
Solution for injection. (injection)
Clear, colourless solution.
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.
Mannitol
Citric acid monohydrate
Sodium citrate
Sodium dihydrogen phosphate dihydrate
Disodium phosphate dihydrate
Sodium chloride
Polysorbate 80
Sodium hydroxide
Water for injections
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:
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:
Not all presentations or pack sizes may be marketed.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany
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
© 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.