Cabazitaxel Teva

cabazitaxel

Opinion

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.

Key facts

Name
Cabazitaxel Teva
Agency product number
EMEA/H/C/004951
International non-proprietary name (INN) or common name
  • cabazitaxel
Active substance
  • cabazitaxel
Therapeutic area
Prostatic Neoplasms
Date opinion adopted
26/04/2019
Company name
Teva B.V.
Status
Negative
Application type
Initial authorisation

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