Hervelous (trastuzumab)
Biosimilar
- Region
- 🇪🇺 EU
- Active substance
- trastuzumab
- Company
- Prestige Biopharma Belgium
- Status
- Application withdrawn
- Therapeutic area
- Stomach Neoplasms; Breast Neoplasms
- Designations
- Biosimilar
- Application
- EMEA/H/C/005880
- ATC
- L01XC03
- Official record
- www.ema.europa.eu
Indication
Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC)
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Enhertu Authorised · Daiichi Sankyo Europe GmbH
- 🇪🇺 Herwenda Authorised · Sandoz GmbH
- 🇪🇺 Herceptin Authorised · Roche Registration GmbH
- 🇪🇺 Phesgo Authorised · Roche Registration GmbH
- 🇪🇺 Kanjinti Authorised · Amgen Europe B.V.
- 🇪🇺 Ontruzant Authorised · Samsung Bioepis NL B.V.
- 🇪🇺 Zercepac Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Herzuma Authorised · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Tuznue Authorised · Prestige Biopharma Belgium
- 🇪🇺 Trazimera Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Dazublys Authorised · CuraTeQ Biologics (Malta) Limited
- 🇪🇺 Kadcyla Authorised · Roche Registration GmbH
Follow Hervelous
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.