Avzivi (bevacizumab)
- Region
- 🇪🇺 EU
- Active substance
- bevacizumab
- Company
- FGK Representative Service GmbH
- Status
- Authorised
- Therapeutic area
- Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Uterine Cervical Neoplasms
- CHMP opinion
- Thu 30 May 2024
- EU approval
- Fri 26 Jul 2024
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/005574
- ATC
- L01XC07
- Official record
- www.ema.europa.eu
Indication
Treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer and recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer first-line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer. first line treatment of patients with advanced and/or metastatic renal cell cancer.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 Orblid Application withdrawn · Laboratoires Delbert
- 🇪🇺 Abevmy Authorised · Biosimilar Collaborations Ireland Limited
- 🇪🇺 Zirabev Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Alymsys Authorised · Mabxience Research SL
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- 🇪🇺 Vegzelma Authorised · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Avastin Authorised · Roche Registration GmbH
- 🇪🇺 Onbevzi Withdrawn · Samsung Bioepis NL B.V.
- 🇪🇺 Ipique Refused · Rotterdam Biologics 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.