Is Docetaxel registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 24 valid registrations of Docetaxel, including DOCADEX 20 mg/ml Injection (20 mg/ml, Concentrate for solution for infusion, SAR 126.30); DOCADEX 80MG/4ML (20 mg/ml, Concentrate for solution for infusion, SAR 505.10); DOCETAXEL ACCORD 20 mg/ml Vial (20 mg/ml, Concentrate for solution for infusion, SAR 111.10); DOCETAXEL EBEWE 10 mg/ml concentration For Solution For Infusion (10 mg/ml, Concentrate for solution for infusion, SAR 199.05); DOCETAXEL SPC 20 mg/ml Solution for Infusion (20 mg/ml, Concentrate for solution for infusion, SAR 801.80).

Is Docetaxel approved by the US FDA?

Drugs@FDA lists 36 application product lines for Docetaxel, including TAXOTERE (Prescription); DOCETAXEL (Prescription); DOCETAXEL (Prescription); DOCETAXEL (Prescription); DOCETAXEL (Prescription).

Is Docetaxel authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Docetaxel: Taxotere, Docetaxel Kabi, Docetaxel Accord.

Is Docetaxel on the WHO Model List of Essential Medicines?

Yes — 8.2.1. Cytotoxic medicines (complementary list): Malignant neoplasms of breast; Other specified malignant neoplasms of breast; Malignant neoplasms of prostate.

Are there safety signals or safety updates for Docetaxel?

EMA PRAC: 5 entries; US FDA: 9 entries (latest 2024-08-26).

Active substance

Docetaxel

SFDA 36
US FDA 36
EMA 11
Health Canada 3
WHO EML 1
Safety 14

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DOCADEX 20 mg/ml Injection	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 126.30	Generic · Prescription	Boston Oncology Arabia	Valid
DOCADEX 80MG/4ML	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 505.10	Generic · Prescription	Boston Oncology Arabia	Valid
DOCETAXEL ACCORD 20 mg/ml Vial	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 111.10	Generic · Prescription	Accord Healthcare S.L.U	Valid
DOCETAXEL ACCORD 20 mg/ml Vial	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 444.40	Generic · Prescription	Accord Healthcare S.L.U	Valid
DOCETAXEL ACCORD 20 mg/ml Vial	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 888.80	Generic · Prescription	Accord Healthcare S.L.U	Valid
DOCETAXEL EBEWE 10 mg/ml concentration For Solution For Infusion	10 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 199.05	Generic · Prescription	EBEWE PHARMA	Valid
DOCETAXEL EBEWE 10 mg/ml concentration For Solution For Infusion	10 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 758.65	Generic · Prescription	EBEWE PHARMA	Valid
DOCETAXEL SPC 20 mg/ml Solution for Infusion	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 801.80	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Docetaxel AqVida 160 mg per 8 ml	20 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 888.80	Generic · Prescription	AqVida GmbH	Valid
Docetaxel AqVida 20 mg per 1 ml	20 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 111.10	Generic · Prescription	AqVida GmbH	Valid
Docetaxel AqVida 80 mg per 4 ml	20 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 444.40	Generic · Prescription	AqVida GmbH	Valid
Docetaxel BOS	10 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 111.10	Generic · Prescription	Boston Oncology Arabia	Valid
Docetaxel BOS	10 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 444.40	Generic · Prescription	Boston Oncology Arabia	Valid
Docetaxel Venus (1 ml)	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 111.10	Generic · Prescription	VENUS REMEDIES LIMITED	Valid
Docetaxel Venus (4 ml)	20 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 444.40	Generic · Prescription	VENUS REMEDIES LIMITED	Valid
Docetere	20 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 444.40	Generic · Prescription	Saudi Amarox	Valid
Docetere	20 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 888.80	Generic · Prescription	Saudi Amarox	Valid
Specrodoce	10 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 434.20	Generic · Prescription	ALTAIF PHARMACEUTICALS COMPANY	Valid
Specrodoce	10 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 108.55	Generic · Prescription	ALTAIF PHARMACEUTICALS COMPANY	Valid
TAXOTERE 20 MG/ML SOLUTION FOR INFUSION	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 323.20	NCE · Prescription	Aventis Pharma S.A.	Valid
TAXOTERE 20 MG/ML SOLUTION FOR INFUSION	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 1292.75	NCE · Prescription	Aventis Pharma S.A.	Valid
TAXOTERE 20 MG/ML SOLUTION FOR INFUSION	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 2585.50	NCE · Prescription	Aventis Pharma S.A.	Valid
Tadoxel	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 111.10	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Tadoxel 80 mg/4 ml	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 444.40	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
DOCETAXEL Actavis 40 mg/ml concentrate for solution for infusion	40 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 890.90	Generic · Prescription	ACTAVIS	Withdrawn by MAH · Not Marketed

11 more — full table

Indications — CHI Daman Drug Formulary

ANAL CANCER; BLADDER CANCER; BONE SARCOMAS; BREAST CANCER EARLY HER-2 -VE; BREAST CANCER HER-2 +VE; BREAST CANCER MET.HER-2 +VE; BREAST CANCER MET.HER-2 -VE; Cervical Cancer; ENDOMETRIAL CANCER; ESOPHAGEAL CANCER; GASTRIC CANCER; HEAD AND NECK CANCER; MALIGNANT NEOPLASM OF THE PANCREAS; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); OVARIAN CANCER; PROSTATE CANCER; SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA; THYROID CANCER-ANAPLASTIC CARCINOMA; VAGINAL AND VULVAR CANCERS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
TAXOTERE	160MG/8ML (20MG/ML)	injectable · injection	SANOFI AVENTIS US	Prescription	14 May 1996
DOCETAXEL	20MG/2ML (10MG/ML); 80MG/8ML (10MG/ML); 160MG/16ML (10MG/ML); 20MG/ML (20MG/ML); 80MG/4ML (20MG/ML); 160MG/8ML (20MG/ML)	injectable · injection	HOSPIRA INC	Prescription	8 Mar 2011
DOCETAXEL	20MG/ML (20MG/ML); 80MG/4ML (20MG/ML); 160MG/8ML (20MG/ML)	injectable · injection	ACCORD HLTHCARE	Prescription	8 Jun 2011
DOCETAXEL	20MG/2ML (10MG/ML); 80MG/8ML (10MG/ML); 160MG/16ML (10MG/ML)	injectable · injection	SANDOZ	Prescription	29 Jun 2011
DOCETAXEL	20MG/ML (20MG/ML); 80MG/4ML (20MG/ML); 140MG/7ML (20MG/ML); 160MG/8ML (20MG/ML)	injectable · injection	ACTAVIS	Prescription	12 Apr 2013
DOCETAXEL	20MG/ML (20MG/ML); 80MG/4ML (20MG/ML)	injectable · injection	DR REDDYS	Prescription	5 Nov 2014
DOCETAXEL	20MG/ML (20MG/ML); 80MG/4ML (20MG/ML); 160MG/8ML (20MG/ML)	injectable · injection	SHILPA	Prescription	22 Dec 2015
DOCETAXEL	20MG/ML (20MG/ML); 80MG/4ML (20MG/ML); 160MG/8ML (20MG/ML)	injectable · injection	HENGRUI PHARMA	Prescription	9 Aug 2017
DOCETAXEL	20MG/ML (20MG/ML); 80MG/4ML (20MG/ML); 160MG/8ML (20MG/ML)	injectable · injection	AMNEAL	Prescription	19 Jan 2018
DOCETAXEL	160MG/16ML (10MG/ML)	injectable · injection	MYLAN LABS LTD	Prescription	30 Apr 2018
DOCETAXEL	20MG/2ML (10MG/ML)	injectable · injection	MYLAN LABS LTD	Prescription	2 Jul 2018
DOCETAXEL	80MG/8ML (10MG/ML)	injectable · injection	MYLAN LABS LTD	Prescription	6 Jul 2018
DOCETAXEL	20MG/2ML (10MG/ML); 80MG/8ML (10MG/ML); 160MG/16ML (10MG/ML)	injectable · injection	MEITHEAL	Prescription	24 Aug 2018
DOCETAXEL	160MG/8ML (20MG/ML)	injectable · injection	MYLAN LABS LTD	Prescription	1 Apr 2019
DOCETAXEL	20MG/ML (20MG/ML); 80MG/4ML (20MG/ML); 160MG/8ML (20MG/ML)	injectable · injection	ADAPTIS	Prescription	16 May 2019
DOCETAXEL	20MG/ML (20MG/ML); 80MG/4ML (20MG/ML)	injectable · injection	HIKMA	Prescription	14 Jan 2021
DOCETAXEL	20MG/2ML (10MG/ML); 80MG/8ML (10MG/ML); 160MG/16ML (10MG/ML)	injectable · injection	GLAND	Prescription	1 Jul 2021
DOCIVYX	20MG/2ML (10MG/ML); 80MG/8ML (10MG/ML); 160MG/16ML (10MG/ML)	solution · intravenous	AVYXA HOLDINGS	Prescription	22 Nov 2022
DOCETAXEL	160MG/16ML	injectable · injection	AVYXA HOLDINGS	Prescription	22 Nov 2022
DOCETAXEL	20MG/2ML (10MG/ML); 80MG/8ML (10MG/ML); 160MG/16ML (10MG/ML)	injectable · injection	ALEMBIC	Prescription	28 Feb 2023
DOCETAXEL	20MG/ML (20MG/ML); 80MG/4ML (20MG/ML); 160MG/8ML (20MG/ML)	injectable · injection	HERITAGE	Prescription	28 Feb 2024
BEIZRAY	80MG/4ML (20MG/ML); 20MG/ML (20MG/ML)	solution · intravenous	ZHUHAI	Prescription	23 Oct 2024
TAXOTERE	40MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 20MG/ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 80MG/4ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	SANOFI AVENTIS US	Discontinued	14 May 1996
DOCETAXEL	120MG/6ML (20MG/ML)	injectable · injection	HOSPIRA INC	Discontinued	8 Mar 2011
DOCEFREZ	20MG/VIAL; 80MG/VIAL	injectable · injection	SUN PHARM	Discontinued	3 May 2011

11 more — full table

EMA European Union — centrally authorised medicines

Taxotere Sanofi Winthrop Industrie · Authorised · authorised 27 Nov 1995 · ATC L01CD02

Therapeutic indication (EMA)

Breast cancer Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Taxotere 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 Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Docetaxel Kabi Fresenius Kabi Deutschland GmbH · Authorised · authorised 22 May 2012 · ATC L01CD02

Therapeutic indication (EMA)

Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Kabi 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. Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Kabi 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 Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer. Docetaxel Kabi in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer. Gastric adenocarcinoma Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Docetaxel Accord Accord Healthcare S.L.U. · Authorised · authorised 22 May 2012 · ATC L01CD02

Therapeutic indication (EMA)

Breast cancer Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Accord 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. Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Accord 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 Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Docetaxel Mylan Mylan S.A.S. · Application withdrawn

Docetaxel SUN Sun Pharmaceutical Industries Europe B.V. · Application withdrawn · ATC L01CD02

Therapeutic indication (EMA)

Treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, head and neck cancer.

Docetaxel Zentiva (previously Docetaxel Winthrop) Zentiva k.s. · Withdrawn · authorised 20 Apr 2007 · ATC L01CD02

Therapeutic indication (EMA)

Breast cancer Docetaxel Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Winthrop in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Winthrop 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. Docetaxel Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Winthrop in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Winthrop 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 Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Docetaxel Teva Teva B.V. · Withdrawn · authorised 26 Jan 2010 · ATC L01CD02

Therapeutic indication (EMA)

Breast cancer Docetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Teva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Teva 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. Docetaxel Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Teva 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 in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Teva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Teva in combination with cisplatin and 5 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Docefrez Sun Pharmaceutical Industries Europe B.V. · Withdrawn · authorised 10 May 2010 · ATC L01CD02

Therapeutic indication (EMA)

Breast cancer Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel 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. Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small cell lung cancer Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Docetaxel 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 in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Docetaxel Teva Pharma Teva Pharma B.V. · Lapsed · authorised 21 Jan 2011 · ATC L01CD02

Therapeutic indication (EMA)

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.

Docetaxel Mylan Mylan S.A.S. · Lapsed · authorised 31 Jan 2012 · ATC L01CD02

Therapeutic indication (EMA)

Treatment of breast cancer, special forms of lung cancer (non-small-cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer.

Taxespira (previously Docetaxel Hospira UK Limited ) Hospira UK Limited · Withdrawn · authorised 28 Aug 2015 · ATC L01CD02

Therapeutic indication (EMA)

Breast cancer Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxespira in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxespira 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. Taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. Taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small cell lung cancer Taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Taxespira 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 Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DOCETAXEL INJECTION	02439336	10 MG / ML	SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
DOCETAXEL INJECTION	02458020	20 MG / ML	SOLUTION · INTRAVENOUS	BIOLYSE PHARMA CORPORATION
DOCETAXEL INJECTION USP	02361957	10 MG / ML	SOLUTION · INTRAVENOUS	PFIZER CANADA ULC

WHO WHO Model List of Essential Medicines (2025)

8.2.1. Cytotoxic medicines · complementary
Malignant neoplasms of breast; Other specified malignant neoplasms of breast; Malignant neoplasms of prostate
Parenteral > General injections > IV: 20 mg per mL; 40 mg per mL

Safety signals and safety-related labeling changes

US FDA 26 Aug 2024 DOCETAXEL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Apr 2024 DOCETAXEL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 21 Sep 2023 DOCETAXEL — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 20 Sep 2023 DOCETAXEL — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Aug 2023 DOCEFREZ — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 Jul 2023 DOCETAXEL — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 May 2023 DOCETAXEL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Jan 2023 TAXOTERE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Sep 2018 DOCETAXEL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 9 Jun 2017 PRAC signal: Unexpected seriousness of reported adverse drug reactions (ADRs) with docetaxel in particular neutropenic enterocolitis and suspicion of an increase in ADR reporting rate in France with docetaxel-containing products
Action for MAH: update of the product information: No
EMA PRAC 6 Apr 2017 PRAC signal: Unexpected seriousness of reported adverse drug reactions (ADRs) with docetaxel in particular neutropenic enterocolitis and suspicion of an increase in ADR reporting rate in France with docetaxel-containing products
Action for MAH: update of the product information: No
EMA PRAC 9 Mar 2017 PRAC signal: Unexpected seriousness of reported adverse drug reactions (ADRs) with docetaxel in particular neutropenic enterocolitis and suspicion of an increase in ADR reporting rate in France with docetaxel-containing products
Action for MAH: update of the product information: No
EMA PRAC 11 Apr 2013 PRAC signal: Serious and fatal drug interactions involving CYP3A4 inhibitors (grapefruit juice and dronedarone)
Action for MAH: update of the product information: Yes
EMA PRAC 11 Apr 2013 PRAC signal: Thrombotic microangiopathy
Action for MAH: update of the product information: No

All safety entries for docetaxel →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.