Drug name: Humira ®
API type: Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells.
Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors.
ATC code: L04AB04
Original license holder:
Marketing authorisation numbers: EU/1/03/256/001 - 015
Marketing authorisation holder: AbbVie Ltd; Maidenhead; SL6 4UB; United Kingdom
Name of the manufacturer of the biological active substance:
Name and address of the manufacturer responsible for batch release:
Max shelf life: 24 months
Storage conditions: 2°C – 8°C
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