Gefitinib Mylan (gefitinib)
Generic
- Region
- 🇪🇺 EU
- Active substance
- gefitinib
- Company
- Mylan Pharmaceuticals Limited
- Status
- Withdrawn
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 26 Jul 2018
- EU approval
- Thu 27 Sep 2018
- Designations
- Generic
- Application
- EMEA/H/C/004826
- ATC
- L01XE02
- Official record
- www.ema.europa.eu
Indication
Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with activating mutations of EGFR TK.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Iressa 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.