Ituxredi (rituximab)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- rituximab
- Company
- Reddy Holding GmbH
- Status
- Authorised
- Therapeutic area
- Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid
- CHMP opinion
- Thu 25 Jul 2024
- EU approval
- Thu 19 Sep 2024
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006224
- ATC
- L01FA01
- Official record
- www.ema.europa.eu
Indication
Treatment of Non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukaemia (CLL) and rheumatoid arthritis
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Riximyo Authorised · Sandoz GmbH
- 🇪🇺 Rixathon Authorised · Sandoz GmbH
- 🇺🇸 Zimrixby Approved · Dr Reddys Labs Sa
- 🇪🇺 Ruxience Authorised · Pfizer Europe MA EEIG
- 🇪🇺 MabThera Authorised · Roche Registration GmbH
- 🇪🇺 Blitzima Authorised · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Truxima Authorised · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Ritemvia Withdrawn · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Rituximab Mabion Application withdrawn · Mabion Spolka Akcyjna
- 🇪🇺 Rituzena (previously Tuxella) Withdrawn · Celltrion Healthcare Hungary Kft.
Follow Ituxredi
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.