Tremelimumab AstraZeneca (tremelimumab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- tremelimumab
- Company
- AstraZeneca AB
- Status
- Withdrawn
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 15 Dec 2022
- EU approval
- Mon 20 Feb 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004650
- ATC
- L01FX20
- Official record
- www.ema.europa.eu
Indication
Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Imjudo Authorised · AstraZeneca AB
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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.