- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 15 January 2019, the European Commission withdrew the marketing authorisation for Cyltezo (adalimumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Boehringer Ingelheim International GmbH, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Cyltezo was granted marketing authorisation in the EU on 10 November 2017 for treatment of Rheumatoid arthritis, Juvenile idiopathic arthritis, Axial spondyloarthritis, Psoriatic arthritis, Psoriasis, Paediatric plaque psoriasis, Hidradenitis suppurativa (HS), Crohn’s disease, Paediatric Crohn's disease, Ulcerative colitis, Uveitis, Paediatric Uveitis. The marketing authorisation was initially valid for a 5-year period. The product had never been marketed in the EU.
Cyltezo is a biosimilar medicine of Humira. There are other biosimilar medicinal products of Humira authorised and marketed in the EU.
The European Public Assessment Report (EPAR) for Cyltezo is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Cyltezo
- Active substance
- adalimumab
- International non-proprietary name (INN) or common name
- adalimumab
- Therapeutic area (MeSH)
- Hidradenitis Suppurativa
- Arthritis, Psoriatic
- Psoriasis
- Crohn Disease
- Arthritis, Juvenile Rheumatoid
- Uveitis
- Arthritis, Rheumatoid
- Colitis, Ulcerative
- Spondylitis, Ankylosing
- Anatomical therapeutic chemical (ATC) code
- L04AB04
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Please refer to section 4.1 of the Summary of product characteristics in the product information document.