Is Plerixafor registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Plerixafor, including Azafor (20 mg/ml, Solution for injection, SAR 14507.70); HEMABO 24MG/1.2ML (20 mg/ml, Solution for injection, SAR 11847.95); MOZOBIL 24mg/1.2ml solution for injection (20 mg/ml, Solution for injection, SAR 15876.40); Plerix (20 mg/ml, Solution for injection, SAR 15716.65).

Is Plerixafor approved by the US FDA?

Drugs@FDA lists 10 application product lines for Plerixafor, including MOZOBIL (Prescription); PLERIXAFOR (Prescription); PLERIXAFOR (Prescription); PLERIXAFOR (Prescription); PLERIXAFOR (Prescription).

Is Plerixafor authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Plerixafor: Mozobil, Plerixafor Accord.

Are there safety signals or safety updates for Plerixafor?

US FDA: 1 entry (latest 2023-09-21).

Active substance

Plerixafor

SFDA 4
US FDA 10
EMA 2
Health Canada 2
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Azafor	20 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 14507.70	Generic · Prescription	Seacross Pharmaceuticals Ltd	Valid
HEMABO 24MG/1.2ML	20 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 11847.95	Generic · Prescription	Boston Oncology Arabia	Valid
MOZOBIL 24mg/1.2ml solution for injection	20 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 15876.40	NCE · Prescription	Sanofi B.V	Valid
Plerix	20 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 15716.65	Generic · Prescription	Saudi Amarox	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
MOZOBIL	24MG/1.2ML (20MG/ML)	solution · subcutaneous	GENZYME	Prescription	15 Dec 2008
PLERIXAFOR	24MG/1.2ML (20MG/ML)	solution · subcutaneous	DR REDDYS	Prescription	24 Jul 2023
PLERIXAFOR	24MG/1.2ML (20MG/ML)	solution · subcutaneous	MSN	Prescription	24 Jul 2023
PLERIXAFOR	24MG/1.2ML (20MG/ML)	solution · subcutaneous	EUGIA PHARMA	Prescription	24 Jul 2023
PLERIXAFOR	24MG/1.2ML (20MG/ML)	solution · subcutaneous	AMNEAL	Prescription	24 Jul 2023
PLERIXAFOR	24MG/1.2ML (20MG/ML)	solution · subcutaneous	MEITHEAL	Prescription	24 Jul 2023
PLERIXAFOR	24MG/1.2ML (20MG/ML)	solution · subcutaneous	GLAND	Prescription	3 May 2024
PLERIXAFOR	24MG/1.2ML (20MG/ML)	solution · subcutaneous	HETERO LABS LTD VI	Prescription	16 Jun 2025
PLERIXAFOR	24MG/1.2ML (20MG/ML)	solution · subcutaneous	TEVA PHARMS USA INC	Discontinued	24 Jul 2023
PLERIXAFOR	24MG/1.2ML (20MG/ML)	solution · subcutaneous	ZYDUS PHARMS	Discontinued	26 Jul 2023

EMA European Union — centrally authorised medicines

Mozobil Sanofi B.V. · Authorised · authorised 30 Jul 2009 · ATC L03AX16

Therapeutic indication (EMA)

Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.

Plerixafor Accord Accord Healthcare S.L.U. · Authorised · authorised 16 Dec 2022 · ATC L03AX16

Therapeutic indication (EMA)

Adult patients Plerixafor Accord is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4.2). Paediatric patients (1 to less than 18 years) Plerixafor Accord is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.2).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PLERIXAFOR INJECTION	02529815	20 MG / ML	SOLUTION · SUBCUTANEOUS	JAMP PHARMA CORPORATION
PLERIXAFOR INJECTION	02539454	20 MG / ML	SOLUTION · SUBCUTANEOUS	EUGIA PHARMA INC.

Safety signals and safety-related labeling changes

US FDA 21 Sep 2023 MOZOBIL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for plerixafor →

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.