Lextemy
Withdrawn
This medicine's authorisation has been withdrawn
bevacizumab
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 21 June 2021, the European Commission withdrew the marketing authorisation for Lextemy (bevacizumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Mylan IRE Healthcare Limited, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Lextemy was granted marketing authorisation in the EU on 21 April 2021 for 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.
The marketing authorisation was initially valid for a 5-year period. Lextemy was a duplicate application to Abevmy, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Abevmy.
The European Public Assessment Report (EPAR) for Lextemy is updated to indicate that the marketing authorisation is no longer valid.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Lextemy
- Active substance
- bevacizumab
- International non-proprietary name (INN) or common name
- bevacizumab
- Therapeutic area (MeSH)
- Colorectal Neoplasms
- Breast Neoplasms
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Renal Cell
- Uterine Cervical Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01XC07
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
News on Lextemy
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