Zessly (infliximab)
Biosimilar
- Region
- 🇪🇺 EU
- Active substance
- infliximab
- Company
- Sandoz GmbH
- Status
- Authorised
- Therapeutic area
- Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
- CHMP opinion
- Thu 22 Mar 2018
- EU approval
- Fri 18 May 2018
- Designations
- Biosimilar
- Application
- EMEA/H/C/004647
- ATC
- L04AB02
- Official record
- www.ema.europa.eu
Indication
Treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 ABP 710 Application withdrawn · Amgen Europe B.V.
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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.