Herwenda (trastuzumab)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- trastuzumab
- Company
- Sandoz GmbH
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms; Stomach Neoplasms
- CHMP opinion
- Thu 14 Sep 2023
- EU approval
- Wed 15 Nov 2023
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/005769
- 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
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- 🇪🇺 Kadcyla Authorised · Roche Registration GmbH
- 🇪🇺 Ogivri Authorised · Biosimilar Collaborations Ireland Limited
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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.