Cyltezo (adalimumab)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- adalimumab
- Company
- Boehringer Ingelheim International GmbH
- Status
- Withdrawn
- Therapeutic area
- Hidradenitis Suppurativa; Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
- EU approval
- Fri 10 Nov 2017
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/004319
- ATC
- L04AB04
- Official record
- www.ema.europa.eu
Indication
Please refer to section 4.1 of the Summary of product characteristics in the product information document.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Idacio Authorised · Fresenius Kabi Deutschland GmbH
- 🇪🇺 Humira Authorised · AbbVie Deutschland GmbH & Co. KG
- 🇪🇺 Yuflyma Authorised · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Hulio Authorised · Biosimilar Collaborations Ireland Limited
- 🇪🇺 Amgevita Authorised · Amgen Europe B.V.
- 🇪🇺 Hukyndra Authorised · Stada Arzneimittel AG
- 🇪🇺 Libmyris Authorised · Stada Arzneimittel AG
- 🇪🇺 Hefiya Authorised · Sandoz GmbH
- 🇪🇺 Imraldi Authorised · Samsung Bioepis NL B.V.
- 🇪🇺 Hyrimoz Authorised · Sandoz GmbH
- 🇪🇺 Amsparity Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Halimatoz Withdrawn · Sandoz GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.