Refused
This medicine was refused authorisation for use in the European Union.
Overview
On 26 April 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Cabazitaxel Teva, intended for the treatment of prostate cancer.
The company that applied for authorisation is Teva B.V. It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
This EPAR was last updated on 24/07/2019
Application details
Product details | |
---|---|
Name |
Cabazitaxel Teva
|
Active substance |
cabazitaxel
|
International non-proprietary name (INN) or common name |
cabazitaxel
|
Therapeutic area (MeSH) |
Prostatic Neoplasms
|
Anatomical therapeutic chemical (ATC) code |
L01CD04
|
Application details | |
---|---|
Marketing-authorisation applicant |
Teva B.V.
|
Date of opinion |
26/04/2019
|
Date of refusal of marketing authorisation |
11/07/2019
|
Assessment history
-
List item
Cabazitaxel Teva : EPAR - Refusal public assessment report (PDF/838.31 KB)
Adopted
First published: 24/07/2019
EMA/280661/2019 -
List item
Questions and answers on the refusal of the marketing authorisation for Cabazitaxel Teva (cabazitaxel) (PDF/98.51 KB)
Adopted
First published: 26/04/2019
Last updated: 24/07/2019
EMA/280533/2019 -