Is Doxorubicin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Doxorubicin, including DOXORUBICIN 2 MG/ML SOLUTION FOR INFUSION (2 mg/ml, Concentrate for solution for infusion, SAR 42.15); DOXORUBICIN 2MG-MLVIAL (2 mg/ml, Concentrate for solution for infusion, SAR 211.10); DOXORUBICIN 2MG/ML SOLUTION FOR INFUSION (2 mg/ml, Concentrate for solution for infusion, SAR 175.05); Deroxi Liposomal (2 mg/ml, Concentrate for solution for infusion, SAR 1493.05); Deroxi Liposomal 50 mg per 25 ml (2 mg/ml, Solution for injection, SAR 3733.95).

Is Doxorubicin approved by the US FDA?

Drugs@FDA lists 32 application product lines for Doxorubicin, including DOXORUBICIN HYDROCHLORIDE (Prescription); DOXORUBICIN HYDROCHLORIDE (Prescription); DOXORUBICIN HYDROCHLORIDE (Prescription); DOXORUBICIN HYDROCHLORIDE (Prescription); DOXORUBICIN HYDROCHLORIDE (Prescription).

Is Doxorubicin authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Doxorubicin: Caelyx pegylated liposomal, Myocet liposomal (previously Myocet).

Is Doxorubicin on the WHO Model List of Essential Medicines?

Yes — 8.2.1. Cytotoxic medicines (complementary list): Diffuse large B-cell lymphoma, not otherwise specified; Plasma cell myeloma; Burkitt lymphoma including Burkitt leukaemia; Lymphoid leukaemia, not elsewhere classified; Anaplastic large cell lymphoma, ALK-negative; Anaplastic large cell lymphoma, ALK-positive; Osteosarcoma of bone or articular cartilage of unspecified sites; Kaposi sarcoma of unspecified primary site; Malignant neoplasms of breast; Other specified malignant neoplasms of breast; Hodgkin lymphoma; Follicular lymphoma; Ewing sarcoma of bone or articular cartilage of unspecified sites; Malignant neoplasms of kidney, except renal pelvis.

Are there safety signals or safety updates for Doxorubicin?

US FDA: 3 entries (latest 2026-03-10).

Active substance

Doxorubicin

SFDA 13
US FDA 32
EMA 6
Health Canada 7
WHO EML 2
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DOXORUBICIN 2 MG/ML SOLUTION FOR INFUSION	2 mg/ml	Concentrate for solution for infusion · Intravenous, Intravesical	1 Vial	SAR 42.15	Generic · Prescription	Accord Healthcare Limited	Valid
DOXORUBICIN 2MG-MLVIAL	2 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 211.10	Generic · Prescription	EBEWE PHARMA	Valid
DOXORUBICIN 2MG-MLVIAL	2 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 105.25	Generic · Prescription	EBEWE PHARMA	Valid
DOXORUBICIN 2MG-MLVIAL	2 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 40.15	Generic · Prescription	EBEWE PHARMA	Valid
DOXORUBICIN 2MG/ML SOLUTION FOR INFUSION	2 mg/ml	Concentrate for solution for infusion · Intravenous, Intravesical	1 Vial	SAR 175.05	Generic · Prescription	Accord Healthcare Limited	Valid
Deroxi Liposomal	2 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 1493.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Deroxi Liposomal 50 mg per 25 ml	2 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 3733.95	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
ADRIBLASTINA 10MG VIAL & SOLV	10 mg	Injection · Intravenous use	1 Vial	SAR 28.30	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed
ADRIBLASTINA 10MG VIAL & SOLV	10 mg	Solution · Intravenous use	1 Vial	SAR 28.30	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed
ADRIBLASTINA 10MG/5ML VIAL	2 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 51.75	Generic · Prescription	Pfizer Australia Pty LTD	Withdrawn by MAH · Not Marketed
ADRIBLASTINA 50MG VIAL & SOLV	50 mg	Injection · Intravenous use	1 Vial	SAR 116.90	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed
ADRIBLASTINA 50MG VIAL & SOLV	50 mg	Solution · Intravenous use	1 Vial	SAR 116.90	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed
ADRIBLASTINA 50MG/25ML VIAL	2 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 116.90	Generic · Prescription	Pfizer Australia Pty LTD	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); BLADDER CANCER; BONE SARCOMAS; BREAST CANCER EARLY HER-2 -VE; BREAST CANCER HER-2 +VE; BREAST CANCER MET.HER-2 -VE; BURKITT`S LYMPHOMA; CASTLEMAN DISEASE; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); ENDOMETRIAL CANCER; FOLLICULAR LYMPHOMA; HODGKIN'S LYMPHOMA; LYMPHOPLASMACYTIC LYMPHOMA; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; MULTIPLE MYELOMA; OVARIAN CANCER; PEDIATRIC B-CELL LYMPHOMA; PERITONEAL MESOTHELIOMA; RETINOBLASTOMA; SMALL CELL LUNG CANCER (SCLC); SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA; T-CELL LYMPHOMA; THYROID CANCER-ANAPLASTIC CARCINOMA; WILMS TUMOR

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

Product	Strength	Form · route	Applicant	Status	First approved
DOXORUBICIN HYDROCHLORIDE	2MG/ML; 200MG/100ML	injectable · injection	PFIZER	Prescription	23 Dec 1987
DOXORUBICIN HYDROCHLORIDE	10MG/VIAL; 20MG/VIAL; 50MG/VIAL	injectable · injection	HIKMA PHARMS	Prescription	17 Mar 1989
DOXORUBICIN HYDROCHLORIDE	2MG/ML	injectable · injection	HIKMA PHARMS	Prescription	17 Mar 1989
DOXORUBICIN HYDROCHLORIDE	200MG/100ML	injectable · injection	HIKMA	Prescription	13 Sep 1994
DOXORUBICIN HYDROCHLORIDE	2MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	26 Oct 1995
DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML); 50MG/25ML (2MG/ML)	injectable, liposomal · injection	BAXTER HLTHCARE CORP	Prescription	17 Nov 1995
DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	injectable · injection	MYLAN LABS LTD	Prescription	28 Oct 2011
DOXORUBICIN HYDROCHLORIDE	2MG/ML	injectable · injection	SUN PHARM INDS	Prescription	15 Feb 2012
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML); 50MG/25ML (2MG/ML)	injectable, liposomal · injection	SUN PHARM	Prescription	4 Feb 2013
DOXORUBICIN HYDROCHLORIDE	2MG/ML	injectable · injection	SAGENT PHARMS	Prescription	18 Mar 2013
DOXORUBICIN HYDROCHLORIDE	2MG/ML; 200MG/100ML	injectable · injection	ACTAVIS INC	Prescription	27 Jun 2014
DOXORUBICIN HYDROCHLORIDE	20MG/VIAL; 50MG/VIAL	injectable · injection	AMNEAL	Prescription	17 Feb 2017
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML); 50MG/25ML (2MG/ML)	injectable, liposomal · injection	DR REDDYS	Prescription	15 May 2017
DOXORUBICIN HYDROCHLORIDE	2MG/ML	injectable · injection	GLAND	Prescription	11 Aug 2017
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML); 50MG/25ML (2MG/ML)	injectable, liposomal · injection	ZYDUS LIFESCIENCES	Prescription	10 Sep 2020
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML); 50MG/25ML (2MG/ML)	injectable, liposomal · injection	AYANA PHARMA LTD	Prescription	12 Oct 2021
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML); 50MG/25ML (2MG/ML)	injectable, liposomal · injection	BAXTER HLTHCARE CORP	Prescription	19 Oct 2022
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML); 50MG/25ML (2MG/ML)	injectable, liposomal · injection	LUPIN	Prescription	16 Jul 2024
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML); 50MG/25ML (2MG/ML)	injectable, liposomal · injection	ALEMBIC	Prescription	27 Jun 2025
DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML); 50MG/25ML (2MG/ML)	injectable, liposomal · injection	QILU PHARM HAINAN	Prescription	3 Feb 2026
DOXORUBICIN HYDROCHLORIDE	10MG/VIAL; 50MG/VIAL; 20MG/VIAL; 150MG/VIAL	injectable · injection	PFIZER	Discontinued	7 Aug 1974
DOXORUBICIN HYDROCHLORIDE	150MG/75ML	injectable · injection	PFIZER	Discontinued	23 Dec 1987
RUBEX	10MG/VIAL; 50MG/VIAL; 100MG/VIAL	injectable · injection	BRISTOL MYERS SQUIBB	Discontinued	13 Apr 1989
DOXORUBICIN HYDROCHLORIDE	10MG/VIAL; 20MG/VIAL; 50MG/VIAL	injectable · injection	PHARMACHEMIE BV	Discontinued	21 May 1990
ADRIAMYCIN PFS	2MG/ML; 200MG/100ML	injectable · injection	PFIZER	Discontinued	30 Jan 1991

7 more — full table

EMA European Union — centrally authorised medicines

Caelyx pegylated liposomal Baxter Holding B.V. · Authorised · authorised 20 Jun 1996 · ATC L01DB

Therapeutic indication (EMA)

Caelyx pegylated liposomal is indicated: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk; for treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen; in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant; for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. Caelyx pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standarddoxorubicin (or other anthracycline).

Myocet liposomal (previously Myocet) CHEPLAPHARM Arzneimittel GmbH · Authorised · authorised 13 Jul 2000 · ATC L01DB01

Therapeutic indication (EMA)

Myocet liposomal, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult women.

Doxorubicin SUN Sun Pharmaceutical Industries Europe B.V. · Application withdrawn

Doxolipad TLC Biopharmaceuticals B.V. · Refused · ATC L01DB01

Therapeutic indication (EMA)

Treatment of breast and ovarian cancer.

Doxorubicin Hydrochloride Tillomed Laboratorios Tillomed Spain S.L.U · Application withdrawn · ATC L01DB01

Therapeutic indication (EMA)

Treatment of breast cancer, ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi's sarcoma.

Celdoxome pegylated liposomal Baxter Holding B.V. · Lapsed · authorised 15 Sep 2022 · ATC L01DB01

Therapeutic indication (EMA)

Celdoxome pegylated liposomal is indicated in adults: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CAELYX	02238389	2 MG / ML	SUSPENSION · INTRAVENOUS	BAXTER CORPORATION
DOXORUBICIN	02410397	2 MG / ML	SOLUTION · INTRAVENOUS; INTRAVESICAL	PFIZER CANADA ULC
DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP	02194465	50 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS; INTRAVESICAL	PFIZER CANADA ULC
DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP	02194473	150 MG / VIAL	POWDER FOR SOLUTION · INTRAVESICAL; INTRAVENOUS	PFIZER CANADA ULC
DOXORUBICIN HYDROCHLORIDE INJECTION	02409275	2 MG / ML	SOLUTION · INTRAVESICAL; INTRAVENOUS	TEVA CANADA LIMITED
DOXORUBICIN INJECTION, BP	02381982	2 MG / ML	SOLUTION · INTRAVENOUS; INTRAVESICAL	ACCORD HEALTHCARE INC
TARO-DOXORUBICIN LIPOSOMAL	02493020	2 MG / ML	SUSPENSION · INTRAVENOUS	TARO PHARMACEUTICALS INC

WHO WHO Model List of Essential Medicines (2025)

8.2.1. Cytotoxic medicines · complementary
Diffuse large B-cell lymphoma, not otherwise specified; Plasma cell myeloma; Burkitt lymphoma including Burkitt leukaemia; Lymphoid leukaemia, not elsewhere classified; Anaplastic large cell lymphoma, ALK-negative; Anaplastic large cell lymphoma, ALK-positive; Osteosarcoma of bone or articular cartilage of unspecified sites; Kaposi sarcoma of unspecified primary site; Malignant neoplasms of breast; Other specified malignant neoplasms of breast; Hodgkin lymphoma; Follicular lymphoma; Ewing sarcoma of bone or articular cartilage of unspecified sites; Malignant neoplasms of kidney, except renal pelvis
Parenteral > General injections > IV: 10 mg in vial (hydrochloride) powder for injection; 50 mg in vial (hydrochloride) powder for injection; 2 mg per mL in 5 mL vial (hydrochloride); 2 mg per mL in 25 mL vial (hydrochloride)
8.2.1. Cytotoxic medicines · complementary
Kaposi sarcoma of unspecified primary site
Parenteral > General injections > IV: 2 mg per mL in 10 mL vial (hydrochloride); 2 mg per mL in 25 mL vial (hydrochloride)

Safety signals and safety-related labeling changes

US FDA 10 Mar 2026 DOXIL (LIPOSOMAL) — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations
US FDA 20 Dec 2019 DOXORUBICIN HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 20 Dec 2019 DOXORUBICIN HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations

All safety entries for doxorubicin →

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.