Is Paclitaxel registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 15 valid registrations of Paclitaxel, including ABRAXANE (5 mg/ml, Powder for suspension, SAR 1157.05); ANZATAX 6MG-ML VIAL (6 mg/ml, concentrate for solution for injection, SAR 135.15); EBETAXEL 6MG-ML SOLU. FOR I.V. INFUSION (6 mg/ml, Concentrate for solution for infusion, SAR 736.15); Ebetaxel 150mg/25ml (6 mg/ml, Concentrate for solution for infusion, SAR 992.15); Ebetaxel 300mg/50ml (6 mg/ml, Concentrate for solution for infusion, SAR 1762.85).

Is Paclitaxel approved by the US FDA?

Drugs@FDA lists 24 application product lines for Paclitaxel, including PACLITAXEL (Prescription); PACLITAXEL (Prescription); PACLITAXEL (Prescription); ABRAXANE (Prescription); PACLITAXEL (Prescription).

Is Paclitaxel authorised in the European Union?

EMA lists 4 centrally authorised medicines containing Paclitaxel: Abraxane, Pazenir, Naveruclif, Apexelsin.

Is Paclitaxel on the WHO Model List of Essential Medicines?

Yes — 8.2.1. Cytotoxic medicines (complementary list): Malignant neoplasms of cervix uteri; Kaposi sarcoma of unspecified primary site; Other specified malignant neoplasms of the ovary; Malignant neoplasms of nasopharynx; Other specified carcinomas of ovary; Other specified malignant neoplasms of bronchus or lung; Other specified malignant neoplasms of breast; Malignant neoplasms of breast.

Are there safety signals or safety updates for Paclitaxel?

EMA PRAC: 2 entries; US FDA: 2 entries (latest 2023-11-21).

Active substance

Paclitaxel

SFDA 16
US FDA 24
EMA 6
Health Canada 5
WHO EML 1
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ABRAXANE	5 mg/ml	Powder for suspension · Intravenous use	1 Vial	SAR 1157.05	NCE · Prescription	Bristol-Myers Squibb / Pharma EEIG	Valid
ANZATAX 6MG-ML VIAL	6 mg/ml	concentrate for solution for injection · Intravenous use	1 Vial	SAR 135.15	NCE · Prescription	Pfizer Australia Pty LTD	Valid
EBETAXEL 6MG-ML SOLU. FOR I.V. INFUSION	6 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 736.15	Generic · Prescription	EBEWE PHARMA	Valid
Ebetaxel 150mg/25ml	6 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 992.15	Generic · Prescription	EBEWE PHARMA	Valid
Ebetaxel 300mg/50ml	6 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 1762.85	Generic · Prescription	EBEWE PHARMA	Valid
Ebetaxel 30mg/5ml	6 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 220.40	Generic · Prescription	EBEWE PHARMA	Valid
Paclitaxel Kabi	6 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 162.80	Generic · Prescription	Fresenius Kabi Oncology Limited	Valid
Paclitaxel Kabi	6 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 510.90	Generic · Prescription	Fresenius Kabi Oncology Limited	Valid
Paclitaxel Kabi	6 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 778.45	Generic · Prescription	Fresenius Kabi Oncology Limited	Valid
Paclitaxel Kabi	6 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 1354.15	Generic · Prescription	Fresenius Kabi Oncology Limited	Valid
Paclitaxel Kabi	6 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 1560.10	Generic · Prescription	Fresenius Kabi Oncology Limited	Valid
ROTUB 6 mg/ml Concentrate For Solution For Infusion	6 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 197.90	Generic · Prescription	VITANE PHARMA GMBH	Valid
ROTUB 6 mg/ml Concentrate For Solution For Infusion	6 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 727.80	Generic · Prescription	VITANE PHARMA GMBH	Valid
ROTUB 6 mg/ml Concentrate For Solution For Infusion	6 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 846.30	Generic · Prescription	VITANE PHARMA GMBH	Valid
ROTUB 6 mg/ml Concentrate For Solution For Infusion	6 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 2209.45	Generic · Prescription	VITANE PHARMA GMBH	Valid
ANZATAX 6MG-ML VIAL	6 mg/ml	concentrate for solution for injection · Intravenous use	1 Vial	SAR 636.95	NCE · Prescription	Pfizer Australia Pty LTD	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

Cervical Cancer; ENDOMETRIAL CANCER; ESOPHAGEAL CANCER; MALIGNANT NEOPLASM OF THE PANCREAS; OVARIAN CANCER; RENAL CELL CARCINOMA (RCC)-COLLECTING DUCT, MEDULLARY NON-CC RCC; VAGINAL AND VULVAR CANCERS

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

Product	Strength	Form · route	Applicant	Status	First approved
PACLITAXEL	6MG/ML	injectable · injection	TEVA PHARMS	Prescription	25 Jan 2002
PACLITAXEL	6MG/ML	injectable · injection	HIKMA PHARMS	Prescription	28 Jan 2002
PACLITAXEL	6MG/ML	injectable · injection	HOSPIRA	Prescription	8 May 2002
ABRAXANE	100MG/VIAL	powder · intravenous	BRISTOL-MYERS	Prescription	7 Jan 2005
PACLITAXEL	6MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	27 Nov 2006
PACLITAXEL	6MG/ML	injectable · injection	ACTAVIS TOTOWA	Prescription	9 Dec 2009
PACLITAXEL	6MG/ML	injectable · injection	GLAND	Prescription	23 Aug 2016
PACLITAXEL	6MG/ML	injectable · injection	ACCORD HLTHCARE	Prescription	17 Aug 2018
PACLITAXEL	6MG/ML	injectable · injection	MSN	Prescription	24 Aug 2020
PACLITAXEL	100MG/VIAL	powder · intravenous	AM REGENT	Prescription	27 Jul 2022
PACLITAXEL	6MG/ML	injectable · injection	ALEMBIC	Prescription	20 Oct 2022
PACLITAXEL	100MG/VIAL	powder · intravenous	TEVA PHARMS INC	Prescription	11 May 2023
PACLITAXEL	100MG/VIAL	powder · intravenous	HENGRUI PHARMA	Prescription	8 Oct 2024
PACLITAXEL	100MG/VIAL	powder · intravenous	CIPLA	Prescription	10 Apr 2025
PACLITAXEL	100MG/VIAL	powder · intravenous	SHUANGCHENG	Prescription	15 May 2025
PACLITAXEL	100MG/VIAL	powder · intravenous	MYLAN	Prescription	19 Aug 2025
TAXOL	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	HQ SPCLT PHARMA	Discontinued	29 Dec 1992
PACLITAXEL	6MG/ML	injectable · injection	PHARMOBEDIENT	Discontinued	25 Jan 2002
PACLITAXEL	6MG/ML	injectable · injection	TEVA PHARMS USA	Discontinued	25 Jan 2002
PACLITAXEL	6MG/ML	injectable · injection	HOSPIRA	Discontinued	1 Aug 2002
PACLITAXEL	6MG/ML	injectable · injection	ACCORD HLTHCARE	Discontinued	12 Nov 2004
PACLITAXEL	6MG/ML	injectable · injection	SANDOZ	Discontinued	26 Dec 2007
PACLITAXEL	6MG/ML	injectable · injection	PLIVA LACHEMA	Discontinued	12 Mar 2008
PACLITAXEL	6MG/ML	injectable · injection	NATCO PHARMA USA	Discontinued	29 Sep 2011

EMA European Union — centrally authorised medicines

Abraxane Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 11 Jan 2008 · ATC L01CD01

Therapeutic indication (EMA)

Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.

Pazenir ratiopharm GmbH · Authorised · authorised 6 May 2019 · ATC L01CD01

Therapeutic indication (EMA)

Pazenir monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Pazenir in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.

Naveruclif Accord Healthcare S.L.U. · Authorised · authorised 5 Jan 2024 · ATC L01CD01

Therapeutic indication (EMA)

Naveruclif monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (see section 4.4). Naveruclif in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Naveruclif in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.

Apexelsin Whiteoak Pharmaceutical B.V. · Authorised · authorised 24 Jul 2024 · ATC L01CD01

Therapeutic indication (EMA)

Apexelsin monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Apexelsin in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Apexelsin in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.

Paxene Norton Healthcare Ltd. · Withdrawn · authorised 19 Jul 1999 · ATC L01CD01

Therapeutic indication (EMA)

Paxene is indicated for the treatment of patients with: advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy; metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy; advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment; metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment; non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin. Limited efficacy data supports this indication (see section 5.1).

Apealea Inceptua AB · Withdrawn · authorised 20 Nov 2018 · ATC L01CD01

Therapeutic indication (EMA)

Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum?sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ABRAXANE FOR INJECTABLE SUSPENSION	02281066	100 MG / VIAL	POWDER FOR SUSPENSION · INTRAVENOUS	BRISTOL-MYERS SQUIBB CANADA
PACLITAXEL FOR INJECTION	02244372	6 MG / ML	SOLUTION · INTRAVENOUS	BIOLYSE PHARMA CORPORATION
PACLITAXEL INJECTION USP	02320150	6 MG / ML	SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
PACLITAXEL INJECTION USP	02391465	6 MG / ML	SOLUTION · INTRAVENOUS	ACCORD HEALTHCARE INC
PACLITAXEL POWDER FOR INJECTABLE SUSPENSION NANOPARTICLE, ALBUMIN-BOUND PACLITAXEL	02496097	100 MG / VIAL	POWDER FOR SUSPENSION · INTRAVENOUS	PANACEA BIOTEC PHARMA LIMITED

WHO WHO Model List of Essential Medicines (2025)

8.2.1. Cytotoxic medicines · complementary
Malignant neoplasms of cervix uteri; Kaposi sarcoma of unspecified primary site; Other specified malignant neoplasms of the ovary; Malignant neoplasms of nasopharynx; Other specified carcinomas of ovary; Other specified malignant neoplasms of bronchus or lung; Other specified malignant neoplasms of breast; Malignant neoplasms of breast
Parenteral > General injections > IV: 6 mg per mL

Safety signals and safety-related labeling changes

US FDA 21 Nov 2023 PACLITAXEL — safety-related labeling change
Labeling sections changed: Use in Specific Populations
EMA PRAC 3 Sep 2020 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No
US FDA 25 Aug 2020 ABRAXANE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 17 Apr 2020 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No

All safety entries for paclitaxel →

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.