Cabazitaxel Teva

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cabazitaxel

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

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