Overview

The marketing authorisation for Docetaxel Teva Pharma has lapsed because it ceased to be marketed in the European Union more than three years ago and an exemption granted by the European Commission has expired.

Docetaxel Teva Pharma : EPAR - Summary for the public

български (BG) (318.47 KB - PDF)
español (ES) (275.38 KB - PDF)
čeština (CS) (294.23 KB - PDF)
dansk (DA) (274.22 KB - PDF)
Deutsch (DE) (275.97 KB - PDF)
eesti keel (ET) (268.9 KB - PDF)
ελληνικά (EL) (321.07 KB - PDF)
français (FR) (276.46 KB - PDF)
italiano (IT) (273.94 KB - PDF)
latviešu valoda (LV) (292.35 KB - PDF)
lietuvių kalba (LT) (284.42 KB - PDF)
magyar (HU) (293.88 KB - PDF)
Malti (MT) (287.11 KB - PDF)
Nederlands (NL) (273.77 KB - PDF)
polski (PL) (287.03 KB - PDF)
português (PT) (275.95 KB - PDF)
română (RO) (274.87 KB - PDF)
slovenčina (SK) (300.68 KB - PDF)
slovenščina (SL) (290.81 KB - PDF)
Suomi (FI) (270.23 KB - PDF)
svenska (SV) (274.16 KB - PDF)

Product information

Docetaxel Teva Pharma : EPAR - Product Information

български (BG) (3.94 MB - PDF)
español (ES) (960.66 KB - PDF)
čeština (CS) (2.44 MB - PDF)
dansk (DA) (1.74 MB - PDF)
Deutsch (DE) (1.89 MB - PDF)
eesti keel (ET) (1.71 MB - PDF)
ελληνικά (EL) (3.36 MB - PDF)
français (FR) (1.88 MB - PDF)
íslenska (IS) (1.88 MB - PDF)
italiano (IT) (1.91 MB - PDF)
latviešu valoda (LV) (2.77 MB - PDF)
lietuvių kalba (LT) (2.16 MB - PDF)
magyar (HU) (1.6 MB - PDF)
Malti (MT) (2.97 MB - PDF)
Nederlands (NL) (1.67 MB - PDF)
norsk (NO) (1.81 MB - PDF)
polski (PL) (2.45 MB - PDF)
português (PT) (2.08 MB - PDF)
română (RO) (1.96 MB - PDF)
slovenčina (SK) (2.43 MB - PDF)
slovenščina (SL) (2.63 MB - PDF)
Suomi (FI) (1.82 MB - PDF)
svenska (SV) (1.71 MB - PDF)

Latest procedure affecting product information: IB/7/G

21/01/2014

Globe icon

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).

Docetaxel Teva Pharma : EPAR - All Authorised presentations

български (BG) (169.26 KB - PDF)
español (ES) (162.51 KB - PDF)
čeština (CS) (168.77 KB - PDF)
dansk (DA) (163.4 KB - PDF)
Deutsch (DE) (164.78 KB - PDF)
eesti keel (ET) (161.32 KB - PDF)
ελληνικά (EL) (176.94 KB - PDF)
français (FR) (162.49 KB - PDF)
íslenska (IS) (163.74 KB - PDF)
italiano (IT) (162.14 KB - PDF)
latviešu valoda (LV) (169.87 KB - PDF)
lietuvių kalba (LT) (163.26 KB - PDF)
magyar (HU) (169.58 KB - PDF)
Malti (MT) (169.93 KB - PDF)
Nederlands (NL) (162.92 KB - PDF)
norsk (NO) (164.22 KB - PDF)
polski (PL) (169.44 KB - PDF)
português (PT) (151.44 KB - PDF)
română (RO) (163.29 KB - PDF)
slovenčina (SK) (169.98 KB - PDF)
slovenščina (SL) (168.26 KB - PDF)
Suomi (FI) (161.51 KB - PDF)
svenska (SV) (163.89 KB - PDF)

Product details

Name of medicine
Docetaxel Teva Pharma
Active substance
docetaxel
International non-proprietary name (INN) or common name
docetaxel
Therapeutic area (MeSH)
  • Carcinoma, Non-Small-Cell Lung
  • Breast Neoplasms
  • Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L01CD02

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

Docetaxel Teva Pharma monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

Non-small-cell lung cancer

Docetaxel Teva Pharma is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.

Docetaxel Teva Pharma in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.

Prostate cancer

Docetaxel Teva Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Authorisation details

EMA product number
EMEA/H/C/002032

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder
Teva Pharma B.V.

Computerweg 10
NL-3542 DR Utrecht
The Netherlands

Marketing authorisation issued
21/01/2011
Revision
6

Assessment history

Docetaxel Teva Pharma : EPAR - Procedural steps taken and scientific information after authorisation

Docetaxel Teva Pharma : EPAR - Public assessment report

CHMP summary of positive opinion for Docetaxel Teva Pharma

This page was last updated on

How useful do you find this page?