Is Bortezomib 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 Bortezomib, including BORTEZOMIB NEAPOLIS (3.5 mg, powder for solution for injection, SAR 2177.05); BORTEZOMIB SPC 3.5 mg Powder for Solution for Infusion (3.5 mg, powder for solution for injection, SAR 3029.45); BORTEZON 3.5 mg Powder For Solution For Injection (3.5 mg, powder for solution for injection, SAR 2177.05); Bortada (2.5 mg, Solution for injection, SAR 2164.65); Bortezomib BOS (3.5 mg, powder for solution for injection, SAR 1523.95).

Is Bortezomib approved by the US FDA?

Drugs@FDA lists 29 application product lines for Bortezomib, including VELCADE (Prescription); BORTEZOMIB (Prescription); BORTEZOMIB (Prescription); BORTEZOMIB (Prescription); BORTEZOMIB (Prescription).

Is Bortezomib authorised in the European Union?

EMA lists 4 centrally authorised medicines containing Bortezomib: Velcade, Bortezomib Accord, Bortezomib Sun, Bortezomib Fresenius Kabi.

Is Bortezomib on the WHO Model List of Essential Medicines?

Yes — 8.2.2. Targeted therapies (complementary list): Plasma cell myeloma.

Are there safety signals or safety updates for Bortezomib?

US FDA: 4 entries (latest 2022-12-09).

Active substance

Bortezomib

SFDA 16
US FDA 29
EMA 5
Health Canada 12
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
BORTEZOMIB NEAPOLIS	3.5 mg	powder for solution for injection · Intravenous, Subcutaneous	1 Vial	SAR 2177.05	Generic · Prescription	LES LABORATORIES NEAPOLIS PHARMA	Valid
BORTEZOMIB SPC 3.5 mg Powder for Solution for Infusion	3.5 mg	powder for solution for injection · Subcutaneous use	1 Vial	SAR 3029.45	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
BORTEZON 3.5 mg Powder For Solution For Injection	3.5 mg	powder for solution for injection · Subcutaneous use	1 Vial	SAR 2177.05	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Bortada	2.5 mg	Solution for injection · Intravenous, Subcutaneous	1 Vial	SAR 2164.65	NCE · Prescription	STADA ARZNEIMITTEL GmbH	Valid
Bortezomib BOS	3.5 mg	powder for solution for injection · Intravenous, Subcutaneous	1 Vial	SAR 1523.95	Generic · Prescription	Boston Oncology Arabia	Valid
Bortezomib EPC	3.5 mg	powder for solution for injection · Intravenous, Subcutaneous	1 Vial	SAR 2177.05	Generic · Prescription	Eastern Pharma Co (EPC)	Valid
Bortezomib EPC	1 mg	powder for solution for injection · Intravenous use	1 Vial	SAR 565.47	Generic · Prescription	Eastern Pharma Co (EPC)	Valid
Borvix	3.5 mg	powder for solution for injection · Intravenous use	1 Vial	SAR 2177.05	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Botzbenav	3.5 mg	powder for solution for injection · Intravenous, Subcutaneous	1 Vial	SAR 2177.05	Generic · Prescription	Eugia Pharma Specialities Limited	Valid
MARZOMO	3.5 mg	Solution for injection · Intramuscular and intravenous use	1 Vial	SAR 2177.05	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Proteomib	3.5 mg	powder for solution for injection · Intravenous, Subcutaneous	1 Vial	SAR 2177.05	Generic · Prescription	VENUS REMEDIES LIMITED	Valid
VEELBORE 3.5 mg Powder For Solution For Injection	3.5 mg	powder for solution for injection · Subcutaneous use	1 Vial	SAR 2692.85	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
VELCADE 3.5MG POWDER FOR I.V. INJECTION	3.5 mg	powder for solution for injection · Subcutaneous use	1 Vial	SAR 3960.05	NCE · Prescription	JANSSEN-CILAG	Valid
Valtroza	3.5 mg/ml	powder for solution for injection · Intravenous, Subcutaneous	1 Vial	SAR 2699.70	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Veltero	3.5 mg	Solution for injection · Intravenous use	10 Vial	SAR 2177.05	Generic · Prescription	Saudi Amarox	Valid
IMOZET 3.5MG POWDER FOR SOLUTION FOR INJECTION	3.5 mg	powder for solution for injection · Intravenous, Subcutaneous	1 Vial	SAR 2418.95	Generic · Prescription	Accord Healthcare S.L.U	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

AMYLOIDOSIS - LIGHT CHAIN; CASTLEMAN DISEASE; HODGKIN'S LYMPHOMA- PEDIATRIC; LYMPHOPLASMACYTIC LYMPHOMA; MANTLE CELL LYMPHOMA; MULTIPLE MYELOMA; RENAL TRANSPLANT; T-CELL LYMPHOMA; THROMBOTIC THROMBOCYTOPENIC PURPURA

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

Product	Strength	Form · route	Applicant	Status	First approved
VELCADE	3.5MG/VIAL	injectable · intravenous, subcutaneous	TAKEDA PHARMS USA	Prescription	13 May 2003
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	APOTEX	Prescription	2 May 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	PHARMASCIENCE INC	Prescription	2 May 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	FRESENIUS KABI USA	Prescription	2 May 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	ZYDUS PHARMS	Prescription	2 May 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	QILU PHARM HAINAN	Prescription	2 May 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	EUGIA PHARMA	Prescription	2 May 2022
BORTEZOMIB	1MG/VIAL; 2.5MG/VIAL	powder · intravenous, subcutaneous	HOSPIRA	Prescription	2 May 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	DR REDDYS	Prescription	26 Jul 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	HOSPIRA	Prescription	26 Jul 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	MSN	Prescription	26 Jul 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	MEITHEAL	Prescription	26 Jul 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	JIANGSU HANSOH PHARM	Prescription	26 Jul 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	RELIANCE LIFE SCI	Prescription	11 Oct 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	HETERO LABS LTD VI	Prescription	3 May 2024
BORTEZOMIB	3.5MG/1.4ML (2.5MG/ML)	solution · intravenous, subcutaneous	SHILPA	Prescription	26 Aug 2024
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	VILIN BIO MED	Prescription	2 Jun 2025
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	SHUANGCHENG	Prescription	17 Dec 2025
BORTEZOMIB	1MG/VIAL; 2.5MG/VIAL	powder · intravenous, subcutaneous	GLAND	Prescription	6 Jan 2026
BORTEZOMIB	3.5MG/VIAL	powder · intravenous	FRESENIUS KABI USA	Discontinued	6 Nov 2017
BORTEZOMIB	3.5MG/VIAL	powder · intravenous	DR REDDYS	Discontinued	4 Oct 2019
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	TEVA PHARMS USA	Discontinued	2 May 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	BAXTER HLTHCARE CORP	Discontinued	2 May 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	CAPLIN ONE LABS	Discontinued	26 Jul 2022
BORTEZOMIB	3.5MG/VIAL	injectable · intravenous, subcutaneous	ACCORD HLTHCARE	Discontinued	26 Jul 2022

4 more — full table

EMA European Union — centrally authorised medicines

Velcade Janssen-Cilag International NV · Authorised · authorised 26 Apr 2004 · ATC L01XG01

Therapeutic indication (EMA)

Velcade as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Velcade in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high dose chemotherapy with haematopoietic stem cell transplantation. Velcade in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high dose chemotherapy with haematopoietic stem cell transplantation. Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Bortezomib Accord Accord Healthcare S.L.U. · Authorised · authorised 20 Jul 2015 · ATC L01XX32

Therapeutic indication (EMA)

Bortezomib Accord as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib Accord in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high?dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Accord in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high?dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Accord in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Bortezomib Sun SUN Pharmaceutical Industries (Europe) B.V. · Authorised · authorised 22 Jul 2016 · ATC L01XG01

Therapeutic indication (EMA)

Bortezomib SUN as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib SUN in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib SUN in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib SUN in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Bortezomib Fresenius Kabi Fresenius Kabi Deutschland GmbH · Authorised · authorised 14 Nov 2019 · ATC L01XG01

Therapeutic indication (EMA)

Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Bortezomib Hospira Pfizer Europe MA EEIG · Withdrawn · authorised 22 Jul 2016 · ATC L01XG01

Therapeutic indication (EMA)

Bortezomib Hospira as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib Hospira in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Hospira in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Hospira in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACT BORTEZOMIB	02438399	3.5 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS; INTRAVENOUS	TEVA CANADA LIMITED
BORTEZOMIB	02456176	3.5 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS; SUBCUTANEOUS	APOTEX INC
BORTEZOMIB FOR INJECTION	02423405	3.5 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS; INTRAVENOUS	TEVA CANADA LIMITED
BORTEZOMIB FOR INJECTION	02452456	3.5 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS; SUBCUTANEOUS	DR REDDY'S LABORATORIES LTD
BORTEZOMIB FOR INJECTION	02467003	2.5 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS; SUBCUTANEOUS	PFIZER CANADA ULC
BORTEZOMIB FOR INJECTION	02485257	3.5 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS; SUBCUTANEOUS	JUNO PHARMACEUTICALS CORP.
BORTEZOMIB FOR INJECTION	02493306	3.5 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS; INTRAVENOUS	MARCAN PHARMACEUTICALS INC
BORTEZOMIB INJECTION	02550075	2.5 MG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	DR REDDY'S LABORATORIES LTD
PMS-BORTEZOMIB	02466708	3.5 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS; SUBCUTANEOUS	PHARMASCIENCE INC
TARO-BORTEZOMIB	02499061	3.5 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS; SUBCUTANEOUS	TARO PHARMACEUTICALS INC
TARO-BORTEZOMIB	02511932	2.5 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS; SUBCUTANEOUS	TARO PHARMACEUTICALS INC
VELCADE	02262452	3.5 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS; SUBCUTANEOUS	JANSSEN INC

WHO WHO Model List of Essential Medicines (2025)

8.2.2. Targeted therapies · complementary
Plasma cell myeloma
Parenteral > General injections > unspecified: 3.5 mg in vial powder for injection

Safety signals and safety-related labeling changes

US FDA 9 Dec 2022 BORTEZOMIB — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
US FDA 28 Feb 2022 BORTEZOMIB — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
US FDA 25 Oct 2021 VELCADE — 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 20 Sep 2021 BORTEZOMIB — 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

All safety entries for bortezomib →

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.